Clinical Evaluation of Daily Disposable Contact Lenses
- Conditions
- Myopia
- Registration Number
- NCT02097030
- Lead Sponsor
- Coopervision, Inc.
- Brief Summary
The objective of the study is to compare the overall subjective preference of filcon II 3 daily disposable silicone hyrogel contact lenses compared to etafilcon A and nelfilcon A daily disposable conventional hydrogel contact lenses.
- Detailed Description
Double-masked, randomised, controlled crossover trial. Subjects were randomized to wear one or the other of the conventional hydriogel lenses; all subjects wore the filcon II 3 lenses. The first randomly assigned lens type was worn for 3 days, with daily replacement, followed by 3 days of wear of the other lens type, with daily replacement.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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 CL wearer
- Must be able to wear their lenses at least 3 full days, 10 hours per day, assuming there are no contraindications for doing so
- Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
- Has less than 1.25 D spectacle cylinder in each eye.
- Baseline vision of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- Is correctable to at least 20/25 distance visual acuity with study contact lenses in each eye
- 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 3 full days)
- Is willing to comply with the visit schedule
- Has never worn contact lenses before.
- Currently wears rigid gas permeable contact lenses.
- Has a history of not achieving comfortable CL wear (3 days per week; > 8 hours/day)
- Has a CL prescription outside the range of - 1.00 to -6.00D
- Has a spectacle cylinder greater than -1.25D 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, (includes rewetting drops, artificial tears and allergy drops), that will affect ocular health. Occasional use is acceptable but not during the trial.
- 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
- Primary Outcome Measures
Name Time Method Overall Lens Preference - Hydrogel vs. Filcon II 3 Study Exit Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).
Overall Lens Preference - All Study Lenses Study Exit Participant's subjective response for overall lens preference after 3 days of daily disposable wear of each pair of lenses. Surveyed at exit. (4 possible ratings: Strongly prefer pair#1, Slightly prefer pair #1, Slightly prefer pair #2, Strongly prefer pair #2).
- Secondary Outcome Measures
Name Time Method Subjective Response for Insertion Baseline Participant's subjective response for insertion measured at baseline. (Insertion Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).
Subjective Response for Vision Baseline and 3 day follow-up Participant's subjective response for vision measured at baseline and at 3 day follow-up of daily disposable wear of lenses. (Vision Scale 0-100, 0=very blurry, 100=very clear).
Overall Satisfaction, Handling 3 Days Participant's subjective response for overall handling satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Overall Satisfaction 3 Days Follow-up Participant's subjective response for overall satisfaction. Measured after 3 days of daily disposable lens wear. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Overall Satisfaction, Comfort 3 Days Follow-up Participant's subjective response for overall comfort satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Subjective Response for Comfort Baseline and 3 day follow-up Participant's subjective response for comfort measured at baseline and 3 day follow-up. (Continuous Comfort Scale 0-100, 0=cannot be worn/causes pain, 100=cannot be felt ever)
Overall Satisfaction, Vision 3 Days Follow-up Participant's subjective response for overall vision satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Lens Fit and Performance - Wettability (Baseline and 3 Days Follow-up) Baseline and 3 days follow-up The investigator's objective assessment for contact lens fit and performance - wettability. Measured at baseline (10-15mins settling) for both study pairs. Wettability (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced).
Subjective Response for Handling (Insertion and Removal) 3 days follow-up Participant's subjective response for handling (insertion and removal) measured at 3 day follow-up of daily disposable wear of lenses. (Handling Scale 0-100, 0=very hard to handle, 100=very easy to handle).
Subjective Response for Dryness 3 Days Follow-up Participant's subjective response for dryness, measured at baseline and after 3 day follow-up of daily disposable wear of lenses. (Dryness Scale 0-100, 0=Cannot be worn/extremely dry, 100=no dryness experienced at any time).
Lens Fit and Performance - Debris (Baseline and 3 Day Follow-up) Baseline and 3 day follow-up The investigator's objective assessment for contact lens fit and performance - debris. Measured at baseline (10-15mins settling) for both study pairs. (Debris scale 0-4; 0.25 steps; 0=no debris, 4=significant debris)
Lens Fit and Performance - Tightness (Baseline and 3 Day Follow-up) Baseline and 3 day follow-up The investigator's objective assessment for contact lens fit and performance - tightness. Measured at baseline (10-15mins settling) for both study pairs. Tightness (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).
Overall Satisfaction, Dryness 3 Days Follow-up Participant's subjective response for overall dryness satisfaction. Measured after 3 days daily disposable wear of lenses. (4 point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied.
Lens Fit and Performance - Deposits (Baseline and 3 Days Follow-up) Baseline and 3 days follow-up The investigator's objective assessment for contact lens fit and performance - deposits. Measured at baseline (10-15mins settling) for both study pairs. Deposits (scale 0-4, 0.25 steps, 0=excellent, 4 severely reduced);
Lens Fit and Performance - Movement (Baseline and 3 Days Follow-up) Baseline and 3 days follow-up The investigator's objective assessment for contact lens fit and performance - movement. Measured at baseline (10-15mins settling) for both study pairs. Movement (scale in millimeters).
Ocular Health - Biomicroscopy 3 Days Follow-up The investigator's objective assessment of ocular health assessed for each study Pair after 3 days wear by biomicroscopy. Bulbar and Limbal Hyperemia; Corneal Staining Type, Extent and Depth, Conjunctival Staining and Indentation. BrienHolden Vision Institute Continuous Scale: 1-4, 0.5 steps (1=Very, 2=Slight, 3=Moderate, 4=Severe)
Lens Fit and Performance - Fit Acceptance Baseline and 3 day follow-up The investigator's objective assessment for contact lens fit and performance - fit acceptance. Measured at baseline and 3 day follow-up (10-15mins settling) for both study pairs. Fit acceptance (Scale 0-4, 0.25 steps, 0=Should not be worn, 4=Perfect).
Trial Locations
- Locations (1)
University of California, Berkeley Clinical Research Center (UCB-CRC)
🇺🇸Berkeley, California, United States
University of California, Berkeley Clinical Research Center (UCB-CRC)🇺🇸Berkeley, California, United States