PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses (PAVES)

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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• Intervention / Treatment: Device: Phase A - olifilcon B with Tangible Coatings; Device: Phase B - etafilcon A with Tangible Coatings

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30324
      • Ross Eyecare
  • Illinois
    • Niles, Illinois, United States, 60714
      • Professional Eye Care Center
  • Indiana
    • Carmel, Indiana, United States, 46032
      • RevolutionEyes
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Optometry on Central
  • Ohio
    • Westerville, Ohio, United States, 43081
      • Professional VisionCare
  • Tennessee
    • Brentwood, Tennessee, United States, 37027
      • Primary Eyecare Group, PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: Phase A - olifilcon B with Tangible Coatings; Daily disposable silicone hydrogel contact lens
Active Comparator: 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.	Device: Phase A - olifilcon B with Tangible Coatings; Daily disposable silicone hydrogel contact lens
Active Comparator: 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.	Device: Phase A - olifilcon B with Tangible Coatings; Daily disposable silicone hydrogel contact lens
Active Comparator: 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.	Device: Phase A - olifilcon B with Tangible Coatings; Daily disposable silicone hydrogel contact lens
Active Comparator: 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.	Device: Phase A - olifilcon B with Tangible Coatings; Daily disposable silicone hydrogel contact lens
Active Comparator: 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.	Device: Phase A - olifilcon B with Tangible Coatings; Daily disposable silicone hydrogel contact lens
Active Comparator: 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.	Device: Phase B - etafilcon A with Tangible Coatings; Daily disposable hydrogel contact lens
Active Comparator: 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.	Device: Phase B - etafilcon A with Tangible Coatings; Daily disposable hydrogel contact lens
Active Comparator: B3 - HydDD to BioTrue; 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; Daily disposable hydrogel contact lens
Active Comparator: B4 - BioTrue to HydDD; 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; Daily disposable hydrogel contact lens
Active Comparator: B5 - HydDD to AqCom+; 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; Daily disposable hydrogel contact lens
Active Comparator: B6 - AqCom+ to HydDD; 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; Daily disposable hydrogel contact lens

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vision Service Plan
• Collaborators: Foresight Regulatory Strategies, Inc.
• Investigators: Principal Investigator: Robin L Chalmers, OD, Clinical Trial Consultant

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2019
• Primary Completion (Actual): August 2, 2019
• Study Completion (Actual): August 2, 2019

Study Registration Dates

• First Submitted: April 17, 2019
• First Submitted That Met QC Criteria: July 23, 2019
• First Posted (Actual): July 25, 2019

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 5, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Contact Lens
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: VS-19-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No