PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses
NCT ID: NCT04032457
Last Updated: 2020-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
144 participants
INTERVENTIONAL
2019-03-15
2019-08-02
Brief Summary
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The primary outcome variables for this study are subjective comfort and lens preference.
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Detailed Description
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The primary outcome variables for this study are subjective comfort and lens preference.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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A1 - SiHyDD to Moist
1 week of Test SiHyDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.
Phase A - olifilcon B with Tangible Coatings
Daily disposable silicone hydrogel contact lens
A2 - Moist to SiHyDD
1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.
Phase A - olifilcon B with Tangible Coatings
Daily disposable silicone hydrogel contact lens
A3 - SiHyDD to OASDD
1 week of Test SiHyDD contact lenses followed by cross over to 1 week of ACUVUE® OASYS 1-Day contact lenses.
Phase A - olifilcon B with Tangible Coatings
Daily disposable silicone hydrogel contact lens
A4 - OASDD to SiHyDD
1 week of ACUVUE® OASYS 1-Day contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.
Phase A - olifilcon B with Tangible Coatings
Daily disposable silicone hydrogel contact lens
A5 - SiHyDD to DT1
1 week of Test SiHyDD contact lenses followed by cross over to 1 week of Alcon DAILIES TOTAL 1® contact lenses.
Phase A - olifilcon B with Tangible Coatings
Daily disposable silicone hydrogel contact lens
A6 - DT1 to SiHyDD
1 week of Alcon DAILIES TOTAL 1® contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.
Phase A - olifilcon B with Tangible Coatings
Daily disposable silicone hydrogel contact lens
B1 - HydDD to Moist
1 week of Test HydDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.
Phase B - etafilcon A with Tangible Coatings
Daily disposable hydrogel contact lens
B2 - Moist to HydDD
1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test HydDD contact lenses.
Phase B - etafilcon A with Tangible Coatings
Daily disposable hydrogel contact lens
B3 - HydDD to BioTrue
1 week of Test HydDD contact lenses followed by cross over to 1 week of BIOTRUE ONEday® contact lenses.
Phase B - etafilcon A with Tangible Coatings
Daily disposable hydrogel contact lens
B4 - BioTrue to HydDD
1 week of BIOTRUE ONEday® contact lenses followed by cross over to 1 week of Test HydDD contact lenses.
Phase B - etafilcon A with Tangible Coatings
Daily disposable hydrogel contact lens
B5 - HydDD to AqCom+
1 week of Test HydDD contact lenses followed by cross over to 1 week of DAILIES® AquaComfort PLUS® contact lenses.
Phase B - etafilcon A with Tangible Coatings
Daily disposable hydrogel contact lens
B6 - AqCom+ to HydDD
1 week of DAILIES® AquaComfort PLUS® contact lenses followed by cross over to 1 week of Test HydDD contact lenses.
Phase B - etafilcon A with Tangible Coatings
Daily disposable hydrogel contact lens
Interventions
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Phase A - olifilcon B with Tangible Coatings
Daily disposable silicone hydrogel contact lens
Phase B - etafilcon A with Tangible Coatings
Daily disposable hydrogel contact lens
Eligibility Criteria
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Inclusion Criteria
* 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
* Vision not correctable to 20/30 with lens powers listed above
18 Years
42 Years
ALL
Yes
Sponsors
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Foresight Regulatory Strategies, Inc.
INDUSTRY
Vision Service Plan
INDUSTRY
Responsible Party
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Principal Investigators
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Robin L Chalmers, OD
Role: PRINCIPAL_INVESTIGATOR
Clinical Trial Consultant
Locations
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Ross Eyecare
Atlanta, Georgia, United States
Professional Eye Care Center
Niles, Illinois, United States
RevolutionEyes
Carmel, Indiana, United States
Andover Optometry on Central
Andover, Massachusetts, United States
Professional VisionCare
Westerville, Ohio, United States
Primary Eyecare Group, PC
Brentwood, Tennessee, United States
Countries
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Other Identifiers
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VS-19-01
Identifier Type: -
Identifier Source: org_study_id
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