PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses

Study Overview
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Brief Summary
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The study will compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel daily disposable soft contact lens (SiHyDD) to three (3) benchmark soft daily disposable lenses (DD) and, subsequently, of a new-to-market hydrogel spherical daily disposable (HydDD) soft contact lens to three (3) other hydrogel daily disposable lenses. . The primary outcome variables for this study are subjective comfort and lens preference.

Detailed Description
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The objective of the study is to compare the short-term clinical performance and wearer and practitioner acceptability in a pilot study of a new-to-market spherical silicone hydrogel olifilcon B with Tangible Coating daily disposable soft contact lens (SiHyDD) to three (3) benchmark soft daily disposable lenses (DD) and, subsequently, of a new-to-market hydrogel etafilcon A with Tangible Coating spherical daily disposable (HydDD) soft contact lens to three (3) other hydrogel daily disposable lenses. . The primary outcome variables for this study are subjective comfort and lens preference.

Official Title
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PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses

Conditions
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Refractive Errors

Intervention / Treatment
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* Device: Phase A - olifilcon B with Tangible Coatings
* Device: Phase B - etafilcon A with Tangible Coatings


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy full-time wearers of spherical daily disposable contact lenses Vision correctable to 20/30 with spherical lenses in powers from +3.00 to +1.00 DS and from -1.00 to -7.00 DS Visual acuity corrected to at least 20/30 with spherical contact lens Exclusion Criteria: Participating in another clinical trial Vision not correctable to 20/30 with lens powers listed above

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized cross-over after 1 week of wear of two lens brands.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A1 - SiHyDD to Moist<br>1 week of Test SiHyDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses. | Device: Phase A - olifilcon B with Tangible Coatings<br>* Daily disposable silicone hydrogel contact lens<br>|
| Active Comparator: A2 - Moist to SiHyDD<br>1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses. | Device: Phase A - olifilcon B with Tangible Coatings<br>* Daily disposable silicone hydrogel contact lens<br>|
| Active Comparator: A3 - SiHyDD to OASDD<br>1 week of Test SiHyDD contact lenses followed by cross over to 1 week of ACUVUE® OASYS 1-Day contact lenses. | Device: Phase A - olifilcon B with Tangible Coatings<br>* Daily disposable silicone hydrogel contact lens<br>|
| Active Comparator: A4 - OASDD to SiHyDD<br>1 week of ACUVUE® OASYS 1-Day contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses. | Device: Phase A - olifilcon B with Tangible Coatings<br>* Daily disposable silicone hydrogel contact lens<br>|
| Active Comparator: A5 - SiHyDD to DT1<br>1 week of Test SiHyDD contact lenses followed by cross over to 1 week of Alcon DAILIES TOTAL 1® contact lenses. | Device: Phase A - olifilcon B with Tangible Coatings<br>* Daily disposable silicone hydrogel contact lens<br>|
| Active Comparator: A6 - DT1 to SiHyDD<br>1 week of Alcon DAILIES TOTAL 1® contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses. | Device: Phase A - olifilcon B with Tangible Coatings<br>* Daily disposable silicone hydrogel contact lens<br>|
| Active Comparator: B1 - HydDD to Moist<br>1 week of Test HydDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses. | Device: Phase B - etafilcon A with Tangible Coatings<br>* Daily disposable hydrogel contact lens<br>|
| Active Comparator: B2 - Moist to HydDD<br>1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test HydDD contact lenses. | Device: Phase B - etafilcon A with Tangible Coatings<br>* Daily disposable hydrogel contact lens<br>|
| Active Comparator: B3 - HydDD to BioTrue<br>1 week of Test HydDD contact lenses followed by cross over to 1 week of BIOTRUE ONEday® contact lenses. | Device: Phase B - etafilcon A with Tangible Coatings<br>* Daily disposable hydrogel contact lens<br>|
| Active Comparator: B4 - BioTrue to HydDD<br>1 week of BIOTRUE ONEday® contact lenses followed by cross over to 1 week of Test HydDD contact lenses. | Device: Phase B - etafilcon A with Tangible Coatings<br>* Daily disposable hydrogel contact lens<br>|
| Active Comparator: B5 - HydDD to AqCom+<br>1 week of Test HydDD contact lenses followed by cross over to 1 week of DAILIES® AquaComfort PLUS® contact lenses. | Device: Phase B - etafilcon A with Tangible Coatings<br>* Daily disposable hydrogel contact lens<br>|
| Active Comparator: B6 - AqCom+ to HydDD<br>1 week of DAILIES® AquaComfort PLUS® contact lenses followed by cross over to 1 week of Test HydDD contact lenses. | Device: Phase B - etafilcon A with Tangible Coatings<br>* Daily disposable hydrogel contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Lens Preference | Subjective preference for either lens intervention or no preference. Likert question with forced preference for Test or Benchmark lens or no preference. | Visit 3 - Approximately 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) score | Difference in CLDEQ-8 score with treatments relative to score with habitual lenses. The scale on the 8-item CLDEQ-8 instrument is from 1 to 33, with each item having a possible 4 or 5 points. | Visit 2 and 3 - Approximately 1 and 2 weeks, respectively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contact Lens