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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01965288
Other study ID # EX-MKTG-42
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2013
Est. completion date May 2014

Study information

Verified date July 2020
Source Coopervision, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare the clinical performance of the Biofinity Toric (comfilcon A) contact lens, versus Air Optix for Astigmatism (lotrafilcon B) over 1 month of daily wear.


Description:

Single masked, open label, randomized, bilateral, crossover study design comparing comfilcon A against lotrafilcon B lenses over 1 month of daily wear for each study lens. Each subject will be randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

- Is between 18 and 40 years of age (inclusive)

- Has had a self-reported visual exam in the last two years

- Is an adapted soft toric contact lens wearer

- Has a contact lens spherical prescription between +6.00 to - 10.00 (inclusive)

- Have no less than 0.75diopter (D) of astigmatism and no more than 2.25D in both eyes.

- Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.

- Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.

- Has clear corneas and no active ocular disease

- Has read, understood and signed the information consent letter.

- Patient contact lens refraction should fit within the available parameters of the study lenses.

- Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).

- Is willing to comply with the visit schedule

Exclusion Criteria:

A person will be excluded from the study if he/she:

- Has a contact lens prescription outside the range of the available parameters of the study lenses.

- Has a spectacle cylinder less than -0.75D or more than -2.25 D of cylinder in either eye.

- Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day)

- Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.

- Presence of clinically significant (grade 2-4) anterior segment abnormalities

- Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.

- Slit lamp findings that would contraindicate contact lens wear such as:

- Pathological dry eye or associated findings

- Pterygium, pinguecula, or corneal scars within the visual axis

- Neovascularization > 0.75 mm in from of the limbus

- Giant papillary conjunctivitis (GCP) worse than grade 1

- Anterior uveitis or iritis (past or present)

- Seborrheic eczema, Seborrheic conjunctivitis

- History of corneal ulcers or fungal infections

- Poor personal hygiene

- Has a known history of corneal hypoesthesia (reduced corneal sensitivity)

- Has aphakia, keratoconus or a highly irregular cornea.

- Has Presbyopia or has dependence on spectacles for near work over the contact lenses.

- Has undergone corneal refractive surgery.

- Is participating in any other type of eye related clinical or research study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
comfilcon A
test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)
lotrafilcon B
test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)

Locations

Country Name City State
Spain Optometry Research Group (GIO) - Optics Department, University of Valencia Valencia

Sponsors (1)

Lead Sponsor Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Daily and Comfortable Wearing Time Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses. (The hours of average comfortable wearing time and average daily wearing time.) Baseline
Primary Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at baseline for all habitual lenses. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling) Baseline
Primary Vision Quality Insertion, During Day, End Day Participant rating of vision quality on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp) Baseline
Primary Vision Stability Insertion, During Day, End Day Participant rating of vision stability on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing) Baseline
Primary Overall Sensation of Moistness Participant rating for overall sensation of moistness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average) Baseline
Primary Overall Sensation of Smoothness Participant rating for overall sensation of smoothness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average) Baseline
Primary Comfort Satisfaction Participant rating for comfort satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) Baseline
Primary Dryness Satisfaction Participant rating for dryness satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) Baseline
Primary Handling Satisfaction Participant rating for handling satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) Baseline
Primary Lens Fit Satisfaction Participant rating for lens fit satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) Baseline
Primary Vision Satisfaction Participant rating for vision satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) Baseline
Primary Overall Satisfaction Participant rating for overall satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) Baseline
Primary Comfort Upon Contact Lens Insertion Participant rating of comfort upon insertion. Collected at dispense for each lens. (0-10; 10=Can't Feel) Dispense
Primary Vision Satisfaction Upon Contact Lens Insertion Participant rating of vision satisfaction upon insertion. Collected at dispense for each lens. (0-10; 10= Very Satisfied) Dispense
Primary Vision Quality With Contact Lens Prescription Participant rating of Vision Quality with contact lens prescription. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp) Dispense
Primary Vision Stability Upon Contact Lens Insertion Participant rating of vision stability on insertion. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp) Dispense
Primary Visual Acuity logMAR Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at dispense for each lens. logMAR (VA). Dispense
Primary Centration Assessment of Lens Fit Performance for centration. Collected at dispense for each lens. (Biomicroscopy; centered or slightly decentered) Dispense
Primary Corneal Coverage Assessment of Lens Fit Performance for corneal coverage. Collected at dispense for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage) Dispense
Primary Post Blink Movement Assessment of Lens Fit Performance for post blink movement. Collected at dispense for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement) Dispense
Primary Lens Orientation Primary Gaze Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Collected at dispense for each lens. (Degree of mislocation relative to lens axis mark.) Dispense
Primary Lens Marking Visibility Assessment of Lens Fit Performance for lens marking visibility. Collected at dispense for each lens. (1-3, 1=excellent, 2=average, 3=poor) Dispense
Primary Lens Stability on Blink Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at dispense for each lens. (No rotation and 5-10 degrees rotation from axis location mark) Dispense
Primary Lens Stability 5-10 Min Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at dispense for each lens. (Varied less than 5 degrees from lens marking location between 5-10 min) Dispense
Primary Lens Overall Stability Assessment of Lens Fit Performance for overall lens stability. Collected at dispense for each lens. (Excellent or Good) Dispense
Primary Rotational Recovery 30/45 Deg Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at dispense for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec) Dispense
Primary Overall Fit Acceptance Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at dispense for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect) Dispense
Primary Daily and Comfortable Wearing Time Participant rating of lens Daily and Comfortable Wearing Time. Collected at 2 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.) 2 weeks
Primary Daily and Comfortable Wearing Time Participant rating of lens Daily and Comfortable Wearing Time. Collected at 4 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.) 4 weeks
Primary Participants Use of Rewetting Drops Proportion of subjects using rewetting drops. Collected at 2 weeks for each lens. (Yes, No) 2 Weeks
Primary Participants Use of Rewetting Drops Proportion of subjects using rewetting drops. Collected at 4 weeks for each lens. (Yes, No) 4 Weeks
Primary Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 2 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling) 2 weeks
Primary Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 4 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling) 4 weeks
Primary Vision Quality Insertion, During Day, End Day, Night Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 2 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp) 2 weeks
Primary Vision Quality Insertion, During Day, End Day, Night Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 4 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp) 4 weeks
Primary Vision Stability on Insertion, During Day, End Day Participant rating of vision stability on insertion, during the day, end of day. Collected at 2 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing) 2 weeks
Primary Vision Stability on Insertion, During Day, End Day Participant rating of vision stability on insertion, during the day, end of day. Collected at 4 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing) 4 weeks
Primary Overall Sensation of Moistness Participant rating for overall sensation of moistness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor) 2 weeks
Primary Overall Sensation of Moistness Participant rating for overall sensation of moistness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor) 4 weeks
Primary Overall Sensation of Smoothness Participant rating for overall sensation of smoothness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor) 2 weeks
Primary Overall Sensation of Smoothness Participant rating for overall sensation of smoothness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor) 4 weeks
Primary Comfort Satisfaction Participant rating for comfort satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) 2 weeks
Primary Comfort Satisfaction Participant rating for comfort satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) 4 weeks
Primary Dryness Satisfaction Participant rating for dryness satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) 2 weeks
Primary Dryness Satisfaction Participant rating for dryness satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) 4 weeks
Primary Handling Satisfaction Participant rating for handling satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) 2 weeks
Primary Handling Satisfaction Participant rating for handling satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) 4 weeks
Primary Vision Satisfaction Participant rating for vision satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) 2 weeks
Primary Vision Satisfaction Participant rating for vision satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) 4 weeks
Primary Lens Fit Satisfaction Participant rating for lens fit satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) 2 weeks
Primary Lens Fit Satisfaction Participant rating for lens fit satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) 4 weeks
Primary Overall Satisfaction Participant rating for overall satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) 2 weeks
Primary Overall Satisfaction Participant rating for overall satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied) 4 weeks
Primary Wavefront Aberrations Root Mean Square (RMS) (3mm) Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm). 2 Weeks
Primary Wavefront Aberrations RMS (3mm) Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm). 4 Weeks
Primary Wavefront Aberrations RMS (5mm) Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm). 2 Weeks
Primary Wavefront Aberrations RMS (5mm) Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm). 4 Weeks
Primary Visual Acuity logMAR Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 2 weeks for each lens. logMAR (VA).
Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)
2 Weeks
Primary Visual Acuity logMAR Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 4 weeks for each lens. logMAR (VA).
Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)
4 Weeks
Primary Lens Orientation Primary Gaze Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 2 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.) 2 weeks
Primary Lens Orientation Primary Gaze Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 4 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.) 4 weeks
Primary Rotational Recovery 30/45 Deg Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec) 2 weeks
Primary Rotational Recovery 30/45 Deg Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec) 4 weeks
Primary Lens Surface Deposits Assessment of lens front surface deposits. Collected at 2 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits =0.5) 2 weeks
Primary Lens Surface Deposits Assessment of lens front surface deposits. Collected at 4 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits =0.5) 4 weeks
Primary Centration Assessment of Lens Fit Performance for centration. Collected at 2 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy) 2 weeks
Primary Centration Assessment of Lens Fit Performance for centration. Collected at 4 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy) 4 weeks
Primary Corneal Coverage Assessment of Lens Fit Performance for corneal coverage. Collected at 2 weks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage) 2 weeks
Primary Corneal Coverage Assessment of Lens Fit Performance for corneal coverage. Collected at 4 weeks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage) 4 weeks
Primary Post Blink Movement Assessment of Lens Fit Performance for post blink movement. Collected at 2 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement) 2 weeks
Primary Post Blink Movement Assessment of Lens Fit Performance for post blink movement. Collected at 4 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement) 4 weeks
Primary Lens Marking Visibility Assessment of Lens Fit Performance for lens marking visibility. Collected at 2 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor) 2 weeks
Primary Lens Marking Visibility Assessment of Lens Fit Performance for lens marking visibility. Collected at 4 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor) 4 weeks
Primary Lens Stability on Blink Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 2 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark) 2 weeks
Primary Lens Stability on Blink Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 4 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark) 4 weeks
Primary Lens Stability 5-10 Min Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 2 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min. 2 weeks
Primary Lens Stability 5-10 Min Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 4 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min. 4 weeks
Primary Overall Stability Assessment of Lens Fit Performance for overall lens stability. Collected at 2 weeks for each lens. (Excellent or Good. 2 weeks
Primary Overall Stability Assessment of Lens Fit Performance for overall lens stability. Collected at 4 weeks for each lens. (Excellent or Good. 4 weeks
Primary Overall Fit Acceptance Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 2 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect) 2 weeks
Primary Overall Fit Acceptance Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 4 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect) 4 weeks
Secondary Limbal Hyperaemia Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) Baseline
Secondary Limbal Hyperaemia Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) 2 weeks
Secondary Limbal Hyperaemia Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) 4 weeks
Secondary Bulbar Hyperaemia Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) Baseline
Secondary Bulbar Hyperaemia Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) 2 weeks
Secondary Bulbar Hyperaemia Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) 4 weeks
Secondary Lower Palpebral Hyperaemia Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) Baseline
Secondary Lower Palpebral Hyperaemia Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) 2 weeks
Secondary Lower Palpebral Hyperaemia Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) 4 weeks
Secondary Corneal Stromal Haze Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) Baseline
Secondary Corneal Stromal Haze Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) 2 weeks
Secondary Corneal Stromal Haze Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) 4 weeks
Secondary Corneal Neovascularization Investigators' objective assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) Baseline
Secondary Corneal Neovascularization Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) 2 weeks
Secondary Corneal Neovascularization Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) 4 weeks
Secondary Corneal Infiltrates Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) Baseline
Secondary Corneal Infiltrates Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) 2 weeks
Secondary Corneal Infiltrates Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe) 4 weeks
Secondary Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses) 2 weeks
Secondary Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses) 2 weeks
Secondary Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses) 4 weeks
Secondary Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses) 4 weeks
Secondary Participants Likelihood of Switching From Habitual Lenses to the Study Lenses Participants likelihood of switching from habitual lenses to either pair of the study lenses when asked; How likely are they to switch from their habitual lenses to either the first study lenses or the second study lenses?" Collected at 4 weeks for each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely) 4 weeks
Secondary Participants Likelihood of Continuing to Wear the Study Lenses. Participants likelihood of continuing to wear either of the pairs of study lenses when asked; "How likely are they to continue to wearing either the first study lenses or the second study lenses?" Collected at 4 weeks fore each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely) 4 weeks
Secondary Participant Recommendation of a Study Lens to Friends, Family or Colleagues Percentage of participants that answer the question, "What study lens they will most likely recommend to friends, family or colleagues?" Collected at end of study. (Forced choice; First Study Lenses, Second Study Lenses) 8 weeks
Secondary Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues. Percentage of participants that answer the question, "How likely are they to recommend either the first pair of study lenses or the second pair of study lenses to friends, family or colleagues?" Collected at study end. (4 point Likert scale; very likely, likely, unlikely, very unlikely) 8 weeks
Secondary Participant Preference for Their Habitual Lenses or Either of the Study Lenses Percentage of participants that answer the question, "Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance?" Collected at study end. (Forced choice; habitual lenses, first study lenses, second study lenses) 8 weeks
Secondary Participant Preference for Either of the Study Lenses Percentage of participants that answer the question, "Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance?" Collected at study end. (Forced choice; first study lenses, second study lenses, neither) 8 weeks
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