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

Not Applicable

Completed

Conditions: Myopia

Interventions: Device: comfilcon A
Device: lotrafilcon B

Registration Number: NCT01952665

Lead Sponsor: Coopervision, Inc.

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

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 63

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

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
lotrafilcon B	comfilcon A	Daily wear soft contact lens lotrafilcon B
comfilcon A	lotrafilcon B	Daily wear soft contact lens comfilcon A

Primary Outcome Measures

Name	Time	Method
Dryness	4 weeks	Participant rating for lens dryness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Dry, 10= No Dryness).
Eye Whiteness/Redness	4 weeks	Participant rating for Eye Whiteness/Redness. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Significant Redness, 10= Totally White)
Overall Comfort Satisfaction	4 weeks	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
Overall Vision Satisfaction	4 weeks	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
Rewetting Drops	4 weeks	Participant use of rewetting drops. Collected at 4 weeks wear for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).
Comfortable Wearing Time	4 weeks	Participant rating of lens Comfortable Wearing Time for both study pairs. Collected at 4 weeks wear. (The hours of average comfortable wearing time)
Overall Sensation of Moistness	4 weeks	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.
Overall Sensation of Smoothness	4 weeks	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.
Overall Dryness Satisfaction	4 weeks	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
Overall Handling Satisfaction	4 weeks	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
Overall Satisfaction	4 weeks	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
Lens Preference, Pair 1 Lotrafilcon B	2 weeks	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 )
Lens Preference	4 weeks	Participant lens preference in regard for comfort, dryness, handling, vision and overall. Collected at 4 weeks. (Forced Choice; Study Pair 1, Study Pair 2).
Lens Preference Comfort, Dryness, Vision and Overall.	4 weeks	Participant lens preference regarding comfort, dryness, vision and overall. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).
Comfort at Insertion	Dispense	Participant rating for lens comfort on insertion. Collected at dispense for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot feel).
Visual Quality	Dispense	Participant rating of visual quality. Collected at dispense for both study pairs. (0-10, 0= Very Poor Vision, 10= Perfectly Sharp, Clear Vision)
Lens Preference, Pair 1 Comfilcon A	2 weeks	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)
Average Daily Wearing Time	4 weeks	Participants measure of average daily wear time for study lenses at 4 weeks.
Comfort	4 weeks	Participant rating for lens comfort. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Uncomfortable, 10= Cannot Feel).
Handling	4 weeks	Participant rating for lens handling. Collected at 4 weeks. (0-10, 0= Very Difficult, 10= Very Easy).
Vision Satisfaction	4 weeks	Participant rating for vision satisfaction. Collected at 4 weeks wear for both study lens pairs. (0-10, 0= Very Unsatisfied, 10= Very Satisfied)
Lens Preference for Handling	4 weeks	Participant lens preference regarding handling. Collected at study exit. (Forced Choice; Study Pair 1, Study Pair 2, Habitual).

Secondary Outcome Measures

Name	Time	Method
Rewetting Drops	2 weeks	Participant use of rewetting drops. Collected at 2 weeks for both study lens pairs. (Uses rewetting drops / Does not use rewetting drops).
Overall Fit Acceptance	4 Weeks	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)
Likelihood of Switching From Habitual Lens to Study Lens	4 weeks	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
Participant Likelihood of Recommendation of a Study Lens	4 weeks	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).
Corneal Coverage	4 Weeks	Assessment of lens corneal coverage. Collected at 4 weeks. (Biomicroscopy; assessed in primary gaze, Normal Coverage or Not Covering)
Surface Wetting	4 Weeks	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)
Surface Deposition	4 Weeks	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)
Binocular Visual Acuity logMAR	4 Weeks	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
Centration	4 Weeks	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)
Post Blink Movement	4 Weeks	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)
Push Up Test	4 Weeks	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)
Likelihood to Continue Wearing the Study Lens	4 weeks	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
Participant Recommendation of a Study Lens	4 weeks	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).

Trial Locations

Locations (6): Family Eye Care Center
🇺🇸
Campbell, California, United States
Golden Optometric Group
🇺🇸
Whittier, California, United States
Drs. Quinn, Foster, &Associates
🇺🇸
Athens, Georgia, United States
Davis EyeCare Associates
🇺🇸
Oak Lawn, Illinois, United States
Kannarr Eye Care LLC
🇺🇸
Pittsburg, Kansas, United States
Complete Eye Care of Medina
🇺🇸
Medina, Minnesota, United States