Clinical Performance of Habitual Hydrogel vs. Silicone Hydrogel Toric Contact Lenses

Astigmatism Clinical Trial

Official title:

Clinical Performance of Habitual Wearers of Hydrogel Toric Lenses When Refitted With Avaira Toric Silicone Hydrogel Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02142361
• Other study ID #: EX-MKTG-48
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: July 2014

Study information

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

Clinical Trial Summary

Evaluate the clinical performance of existing wearers of hydrogel toric lenses when refitted with Avaira toric silicone hydrogel contact lenses over 1 week of wear.

Description:

This is a 60-subject, single masked, bilateral, parallel study design comparing the fitting characteristics of enfilcon A toric lenses against the subjects habitual hydrogel toric lenses (omafilcon A, ocufilcon D or methafilcon B wearers). Subject's habitual toric lenses will be evaluated at the first visit and then re-fitted with a pair of Avaira toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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 - 8.00 (inclusive)

• Have no less than 0.75D of astigmatism and no more than 1.75 D 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:

• 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 -1.75D 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.

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• enfilcon A
Silicone hydrogel toric lenses.

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	Participant's Subjective Rating for Lens Initial Comfort	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)	Baseline and 1 week
Primary	Participant's Subjective Rating for Lens Comfort Prior to Removal	Surveyed prior to removal of each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)	Baseline and 1 week
Primary	Participant's Subjective Rating for Overall Lens Comfort	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel)	Baseline and 1 week
Primary	Participant's Subjective Rating for Dryness During the Day	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)	Baseline and 1 week
Primary	Participant's Subjective Rating for Dryness Prior to Removal	Surveyed prior to removal of each lens pair. Habitual pair at baseline . Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)	Baseline and 1 week
Primary	Participant's Subjective Rating for Overall Dryness	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness)	Baseline and 1 week
Primary	Participant's Subjective Rating for Lens Handling - Insertion	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= very easy)	Baseline and 1 week
Primary	Participant's Subjective Rating for Overall Lens Fit Stability	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very unstable / excessive movement, 10= very stable / good movement)	Baseline and 1 week
Primary	Participant's Subjective Rating for Overall Vision Satisfaction	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=completely dissatisfied, 10= very satisfied)	Baseline and 1 week
Primary	Participant's Subjective Rating for Vision Quality at Insertion	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week .Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)	Baseline and 1 week
Primary	Participant's Subjective Rating for Vision Quality During the Day	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)	Baseline and 1 week
Primary	Participant's Subjective Rating for Vision Quality End of the Day	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week end of the day. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)	Baseline and 1 week
Primary	Participant's Subjective Rating for Night Vision Quality	Surveyed for each lens pair. Habitual pair at baseline. Study pair dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp)	Baseline and 1 week
Primary	Participant's Subjective Rating for Vision Stability at Insertion	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)	Baseline and 1 week
Primary	Participant's Subjective Rating for Vision Stability During the Day	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)	Baseline and 1 week
Primary	Participant's Subjective Rating for Vision Stability at End of Day	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing)	Baseline and 1 week
Primary	Participant's Subjective Rating for Lens Pair Preference	Participants subjective preference in relation to comfort, dryness, handling, vision, lens fit and overall of the patient after wearing the study and their habitual lenses.	1 week
Primary	Participant's Subjective Rating for Overall Satisfaction - Dryness	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)	Baseline and 1 week
Primary	Participant's Subjective Rating for Overall Satisfaction - Handling	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)	Baseline and 1 week
Primary	Participant's Subjective Rating for Overall Satisfaction - Vision	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)	Baseline and 1 week
Primary	Participant's Subjective Rating for Overall Satisfaction - Lens Fit	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)	Baseline and 1 week
Primary	Participant's Subjective Rating for Overall Satisfaction - Overall	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)	Baseline and 1 week
Primary	Clinician's Objective Assessment Monocular High Contrast Distance Visual	Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value.	Baseline and 1 week
Primary	Clinician's Objective Assessment Binocular High Contrast Distance Visual Acuity	Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value	Baseline and 1 week
Primary	Clinician's Assessment Overall Lens Stability-Right Eye	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)	Baseline and 1 week
Primary	Clinician's Assessment Overall Lens Stability-Left Eye	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent)	Baseline and 1 week
Primary	Clinician's Assessment Overall Fit Acceptance- Right Eye	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)	Baseline and 1 week
Primary	Clinician's Assessment Overall Fit Acceptance- Left Eye	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent)	Baseline and 1 week
Primary	Clinician's Assessment Lens Centration-Right Eye	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Lens centration recorded by degree and direction in the primary position. (0-2, 0=centered/optimal, 1=decentered slightly, 2=substantially decentered (>0.5mm))	Baseline and 1 week
Primary	Clinician's Assessment Lens Centration- Left Eye	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Lens centration recorded by degree and direction in the primary positions. (0-2, 0=centered/optimal, 1=decentered slightlty, 2=substantially decentered (>0.5mm)	Baseline and 1 week
Primary	Clinician's Assessment Corneal Coverage-Right Eye	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no, incomplete corneal coverage)	Baseline and 1 week
Primary	Clinicians Assessment Corneal Coverage-Left Eye	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no incomplete corneal coverage)	Baseline and 1 week
Primary	Clinician's Assessment Post-Blink Movement- Right Eye	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement	Baseline and 1 week
Primary	Clinician's Assessment Post-Blink Movement-Left Eye	Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement	Baseline and 1 week
Primary	Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye	Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.	Baseline and 1 week
Primary	Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye	Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees.	Baseline and 1 week
Primary	Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Right Eye	Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.	Baseline and 1 week
Primary	Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Left Eye	Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally.	Baseline and 1 week
Primary	Participant's Subjective Rating for Overall Satisfaction - Comfort	Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied)	Baseline and 1 week