A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear

Myopia Clinical Trial

Official title:

A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01952665
• Other study ID #: EX-MKTG-41
• Status: Completed
• Phase: N/A
• First received: September 18, 2013
• Last updated: August 20, 2015
• Start date: October 2013
• Est. completion date: March 2014

Study information

• Verified date: August 2015
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear

Description:

Two-month, single masked, randomized, bilateral, crossover, 1-month of daily wear in each study lens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

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

• Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study

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

• Is an adapted soft CL wearer

• Has a Contact Lens (CL) spherical prescription between - 1.00 and - 9.00 (inclusive)

• Has less than 0.75D spectacle cylinder in each eye

• Is correctable to a visual acuity of 20/25 or better in both eyes

• Has clear corneas and no active ocular disease

• Has read, understood and signed the information consent letter

• Is willing to comply with the wear schedule (at least 40 hrs per week)

• Is willing to comply with the visit schedule

Exclusion Criteria:

• Has never worn contact lenses before

• Currently wears rigid gas permeable contact lenses

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

• Has a contact lens prescription outside the range of - 1.00 to -9.00D

• Has a spectacle cylinder greater than -0.50D of cylinder in either eye

• Has best corrected spectacle distance vision worse then 20/25 in either eye

• Has any systemic disease affecting ocular health

• Is using any systemic or topical medications that will affect ocular health

• Has any ocular pathology or severe insufficiency of lacrimal secretion

• Has persistent, clinically significant corneal or conjunctival staining

• Has active neovascularization or any central corneal scars

• Is aphakic

• Is presbyopic

• Has undergone corneal refractive surgery

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• comfilcon A
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
• lotrafilcon B
Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.

Locations

Country	Name	City	State
United States	Drs. Quinn, Foster, &Associates	Athens	Georgia
United States	Family Eye Care Center	Campbell	California
United States	Complete Eye Care of Medina	Medina	Minnesota
United States	Davis EyeCare Associates	Oak Lawn	Illinois
United States	Kannarr Eye Care LLC	Pittsburg	Kansas
United States	Golden Optometric Group	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Number of Trials Needed to Achieve Final Dispensing Pair of Study Lenses.	The number of trials needed to achieve final dispensing pair of study lenses. Number of lenses required to dispense the final pair of study lenses. Collected at dispense for both study lens pairs. (Number required; 1, 2, 3, >3)	Dispense	No
Primary	Comfort at Insertion	Participant rating for lens comfort on insertion. Collected at dispense for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot feel).	Dispense	No
Primary	Visual Quality	Participant rating of visual quality. Collected at dispense for both study pairs. (0-10, 0= Very Poor Vision, 10= Perfectly Sharp, Clear Vision)	Dispense	No
Primary	Average Daily Wearing Time	Participants measure of average daily wear time for study lenses at 2 Weeks.	2 weeks	No
Primary	Comfortable Wearing Time	Participant rating of lens Comfortable Wearing Time for both study pairs. After 2 weeks wear for each pair. (The hours of average comfortable wearing time)	2 weeks	No
Primary	Comfort	Participant rating for lens comfort. After 2 weeks wear for each study pair. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).	2 weeks	No
Primary	Dryness	Participant rating for lens dryness. After 2 weeks wear for each study pair. (0-10, 0= Very Dry, 10= No Dryness).	2 weeks	No
Primary	Handling	Participant rating for lens handling. After 2 weeks wear for each study pair. (0-10, 0= Very Difficult, 10= Very Easy).	2 weeks	No
Primary	Vision Satisfaction	Participant rating for vision satisfaction. After 2 weeks wear for each study pair. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)	2 weeks	No
Primary	Eye Whiteness/Redness	Participant rating for Eye Whiteness/Redness. After 2 weeks wear for each study pair. (0-10, 0= Significant Redness, 10= Totally White)	2 weeks	No
Primary	Overall Sensation of Moistness	Participant rating of overall sensation for moistness (hydration). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.	2 weeks	No
Primary	Overall Sensation of Smoothness	Participant rating of overall sensation for smoothness (deposit resistance). After 2 weeks wear for each study pair. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.	2 weeks	No
Primary	Overall Comfort Satisfaction	Participant rating of satisfaction regarding comfort. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied	2 weeks	No
Primary	Overall Dryness Satisfaction	Participant rating of satisfaction regarding dryness. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied	2 weeks	No
Primary	Overall Handling Satisfaction	Participant rating of satisfaction regarding handling. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied	2 weeks	No
Primary	Overall Vision Satisfaction	Participant rating of satisfaction regarding vision. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied	2 weeks	No
Primary	Overall Satisfaction	Participant rating of satisfaction overall. After 2 weeks wear for each study pair. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied	2 weeks	No
Primary	Lens Preference, Pair 1 Comfilcon A	Participant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to comfilcon A as pair 1; Forced choice: Pair 1 or Habitual)	2 weeks	No
Primary	Lens Preference, Pair 1 Lotrafilcon B	Participant preference for habitual lenses or study lenses with regard to comfort, dryness, handling, vision and overall. Collected at 2 weeks for study pair 1. (Randomized to lotrafilcon B as pair 1; Forced choice: Pair 1 or Habitual )	2 weeks	No
Primary	Comfortable Wearing Time	Participant rating of lens Comfortable Wearing Time for both study pairs. Collected at 4 weeks wear. (The hours of average comfortable wearing time)	4 weeks	No
Primary	Average Daily Wearing Time	Participants measure of average daily wear time for study lenses at 4 weeks.	4 weeks	No
Primary	Rewetting Drops	Participant use of rewetting drops. Collected at 4 weeks wear for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).	4 weeks	No
Primary	Comfort	Participant rating for lens comfort. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).	4 weeks	No
Primary	Dryness	Participant rating for lens dryness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Dry, 10= No Dryness).	4 weeks	No
Primary	Handling	Participant rating for lens handling. Collected at 4 weeks. (0-10, 0= Very Difficult, 10= Very Easy).	4 weeks	No
Primary	Vision Satisfaction	Participant rating for vision satisfaction. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)	4 weeks	No
Primary	Eye Whiteness/Redness	Participant rating for Eye Whiteness/Redness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Significant Redness, 10= Totally White)	4 weeks	No
Primary	Overall Sensation of Moistness	Participant rating of overall sensation for moistness (hydration). Collected at 4 weeks wear for both study lens pairs. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.	4 weeks	No
Primary	Overall Sensation of Smoothness	Participant rating of overall sensation for smoothness (deposit resistance). Collected at 4 weeks wear for both study lens pairs. 5-point Likert Scale; 1=Excellent, 2=Good, 3=Average, 4=Below Average, 5=Poor.	4 weeks	No
Primary	Overall Comfort Satisfaction	Participant rating of satisfaction regarding comfort. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied	4 weeks	No
Primary	Overall Dryness Satisfaction	Participant rating of satisfaction regarding dryness. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied	4 weeks	No
Primary	Overall Handling Satisfaction	Participant rating of satisfaction regarding handling. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied	4 weeks	No
Primary	Overall Vision Satisfaction	Participant rating of overall satisfaction for vision. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied	4 weeks	No
Primary	Overall Satisfaction	Participant rating of satisfaction overall. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Completely Satisfied, 2=Somewhat Satisfied, 3=Somewhat Dissatisfied, 4=Completely Dissatisfied	4 weeks	No
Primary	Lens Preference	Participant lens preference in regard for comfort, dryness, handling, vision and overall. Collected at 4 weeks. (Forced Choice; Study Pair 1, Study Pair 2).	4 weeks	No
Primary	Lens Preference Comfort, Dryness, Vision and Overall.	Participant lens preference regarding comfort, dryness, vision and overall. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).	4 weeks	No
Primary	Lens Preference for Handling	Participant lens preference regarding handling. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).	4 weeks	No
Secondary	Binocular Visual Acuity logMAR	Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart	Dispense	No
Secondary	Surface Wetting	Assessment of surface wetting by slit lamp. Collected at dispense for both study pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)	Dispense	No
Secondary	Surface Deposition	Assessment of surface deposition by slit lamp. Collected at dispense for both study pairs. (Grade 0-4 in ½ steps; Clean= 0; Deposited = 4)	Dispense	No
Secondary	Centration	Assessment of lens centration. Collected at dispense for both study pairs. Biomicroscopy; by degree and direction in the primary position. (Rated as Optimal Centration or Not Optimal)	Dispense	No
Secondary	Corneal Coverage	Assessment of lens corneal coverage. Collected at dispense for both study pairs. Biomicroscopy; assessed in primary gaze. (Rated as Normal Coverage or Not Covering)	Dispense	No
Secondary	Post Blink Movement	Assessment of post blink movement. Collected at dispense for both study lens pairs. 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)	Dispense	No
Secondary	Push Up Test	Assessment of lens tightness. Collected at dispense for both study pairs. Digital push up test. Continuous Scale (0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)	Dispense	No
Secondary	Overall Fit Acceptance	Assessment of overall lens fit acceptance. Collected at dispense for both study pairs. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but okay to dispense, 4=perfect)	Dispense	No
Secondary	Rewetting Drops	Participant use of rewetting drops. Collected at 2 weeks for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).	2 weeks	No
Secondary	Binocular Visual Acuity logMAR	Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart	2 Weeks	No
Secondary	Surface Wetting	Assessment of surface wetting by slit lamp. Collected at 2 weeks for both study lens pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)	2 Weeks	No
Secondary	Surface Deposition	Assessment of surface deposition by slit lamp. Collected at 2 weeks for both study lens pairs. (Grade 0-4 in 1/2 steps; 0=clean, 4=deposited)	2 Weeks	No
Secondary	Centration	Assessment of lens centration. Collected at 2 weeks. Biomicroscopy; by degree and direction in the primary position. Optimal versus not optimal	2 Weeks	No
Secondary	Corneal Coverage	Assessment of lens corneal coverage. Collected at 2 weeks for both study pairs. Biomicroscopy; assessed in primary gaze. (Rated as Normal Coverage or Not Covering)	2 Weeks	No
Secondary	Post Blink Movement	Assessment of post blink movement. Collected at 2 weeks for both study lens pairs. Assessed immediately after the blink. (Graded 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)	2 Weeks	No
Secondary	Push Up Test	Assessment of lens tightness. Collected at 2 weeks for both study pairs. Digital push up test. (Continuous Scale 0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)	2 Weeks	No
Secondary	Overall Fit Acceptance	Assessment of overall lens fit acceptance. Collected at 2 weeks for both study pairs. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)	2 Weeks	No
Secondary	Binocular Visual Acuity logMAR	Assessment of visual acuity (VA). Collected at 2 weeks for both study lens pairs. Binocular High Contrast Distance. logMAR (negative logMAR values indicates better Visual Acuity (VA)). 0.0 logMAR = 20/20 snellen chart	4 Weeks	No
Secondary	Surface Wetting	Assessment of surface wetting by slit lamp. Collected at 4 weeks wear for both study lens pairs. 0=Non-wettable surface, 1= > 1 non-wetting area of some magnitude., 2=One non-wetting area of some magnitude, 3=Hazy surface that resolves with a blink. Typical soft lens appearance with long drying time., 4=Smooth uniformly reflective surface. Appearance of a healthy cornea (Grade 0-4 in ½ steps)	4 Weeks	No
Secondary	Surface Deposition	Assessment of surface deposition by slit lamp. Collected at 4 weeks wear for both study lens pairs. (Grade 0-4 in 1/2 steps; 0=clean, 4=deposited)	4 Weeks	No
Secondary	Centration	Assessment of lens centration. Collected at 4 weeks wear for both study lens pairs.. Biomicroscopy, by degree and direction in the primary position. (Optimal Centration or Not Optimal)	4 Weeks	No
Secondary	Corneal Coverage	Assessment of lens corneal coverage. Collected at 4 weeks. (Biomicroscopy; assessed in primary gaze, Normal Coverage or Not Covering)	4 Weeks	No
Secondary	Post Blink Movement	Assessment of post blink movement. Collected at 4 weeks. Assessed immediately after the blink. (Graded 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)	4 Weeks	No
Secondary	Push Up Test	Assessment of lens tightness. Collected at 4 weeks. Digital push up test. (Continuous Scale 0-100%, 0%=Falls from cornea without lid support, 50%= Optimum, 100%= No movement)	4 Weeks	No
Secondary	Overall Fit Acceptance	Assessment of overall lens fit acceptance. Collected at 4 weeks. (0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)	4 Weeks	No
Secondary	Likelihood of Switching From Habitual Lens to Study Lens	Participant likelihood of switching from their habitual lens to the study lens. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=very likely, 2=likely, 3=unlikely, 4=very unlikely	4 weeks	No
Secondary	Likelihood to Continue Wearing the Study Lens	Participant likelihood of continuing wear of the study lense. Collected at 4 weeks wear for both study lens pairs. 4-point Likert Scale; 1=Very Likely, 2=Likely, 3=Unlikely, 4=Very Unlikely	4 weeks	No
Secondary	Participant Recommendation of a Study Lens	Participant most likely recommendation of which study lens to friends, family or colleagues. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2).	4 weeks	No
Secondary	Participant Likelihood of Recommendation of a Study Lens	Participant likelihood of recommending a study lens to friends. Collected at study exit. (1-4; 1=Very Unlikely, 2=Unlikely, 3=Likely, 4=Very Likely).	4 weeks	No