PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses
PAVES
1 other identifier
interventional
144
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2019
Shorter than P25 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2019
CompletedFirst Submitted
Initial submission to the registry
April 17, 2019
CompletedFirst Posted
Study publicly available on registry
July 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 2, 2019
CompletedOctober 6, 2020
October 1, 2020
5 months
April 17, 2019
October 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) score
Visit 2 and 3 - Approximately 1 and 2 weeks, respectively
Study Arms (12)
A1 - SiHyDD to Moist
ACTIVE COMPARATOR1 week of Test SiHyDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.
A2 - Moist to SiHyDD
ACTIVE COMPARATOR1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.
A3 - SiHyDD to OASDD
ACTIVE COMPARATOR1 week of Test SiHyDD contact lenses followed by cross over to 1 week of ACUVUE® OASYS 1-Day contact lenses.
A4 - OASDD to SiHyDD
ACTIVE COMPARATOR1 week of ACUVUE® OASYS 1-Day contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.
A5 - SiHyDD to DT1
ACTIVE COMPARATOR1 week of Test SiHyDD contact lenses followed by cross over to 1 week of Alcon DAILIES TOTAL 1® contact lenses.
A6 - DT1 to SiHyDD
ACTIVE COMPARATOR1 week of Alcon DAILIES TOTAL 1® contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.
B1 - HydDD to Moist
ACTIVE COMPARATOR1 week of Test HydDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.
B2 - Moist to HydDD
ACTIVE COMPARATOR1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test HydDD contact lenses.
B3 - HydDD to BioTrue
ACTIVE COMPARATOR1 week of Test HydDD contact lenses followed by cross over to 1 week of BIOTRUE ONEday® contact lenses.
B4 - BioTrue to HydDD
ACTIVE COMPARATOR1 week of BIOTRUE ONEday® contact lenses followed by cross over to 1 week of Test HydDD contact lenses.
B5 - HydDD to AqCom+
ACTIVE COMPARATOR1 week of Test HydDD contact lenses followed by cross over to 1 week of DAILIES® AquaComfort PLUS® contact lenses.
B6 - AqCom+ to HydDD
ACTIVE COMPARATOR1 week of DAILIES® AquaComfort PLUS® contact lenses followed by cross over to 1 week of Test HydDD contact lenses.
Interventions
Daily disposable silicone hydrogel contact lens
Daily disposable hydrogel contact lens
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Participating in another clinical trial
- Vision not correctable to 20/30 with lens powers listed above
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vision Service Planlead
- Foresight Regulatory Strategies, Inc.collaborator
Study Sites (6)
Ross Eyecare
Atlanta, Georgia, 30324, United States
Professional Eye Care Center
Niles, Illinois, 60714, United States
RevolutionEyes
Carmel, Indiana, 46032, United States
Andover Optometry on Central
Andover, Massachusetts, 01810, United States
Professional VisionCare
Westerville, Ohio, 43081, United States
Primary Eyecare Group, PC
Brentwood, Tennessee, 37027, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robin L Chalmers, OD
Clinical Trial Consultant
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Masking Details
- Clinician masking achieved by clinic coordinator dispensing lenses. Open label to participants.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2019
First Posted
July 25, 2019
Study Start
March 15, 2019
Primary Completion
August 2, 2019
Study Completion
August 2, 2019
Last Updated
October 6, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share