PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses

Not Applicable

Completed

• Conditions: Refractive Errors
• Interventions: Device: Phase B - etafilcon A with Tangible Coatings; Device: Phase A - olifilcon B with Tangible Coatings

• Registration Number: NCT04032457
• Lead Sponsor: Vision Service Plan

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.

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 Timeline

• Study Start: 2019-03-15
• Study First Submitted: 2019-04-17
• Study First Submitted QC: 2019-07-23
• Study First Posted: 2019-07-25
• Primary Completion: 2019-08-02
• Study Completion: 2019-08-02
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B1 - HydDD to Moist	Phase B - etafilcon A with Tangible Coatings	1 week of Test HydDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.
A1 - SiHyDD to Moist	Phase A - olifilcon B with Tangible Coatings	1 week of Test SiHyDD contact lenses followed by cross over to 1 week of 1-DAY ACUVUE® Moist contact lenses.
B2 - Moist to HydDD	Phase B - etafilcon A with Tangible Coatings	1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test HydDD contact lenses.
B6 - AqCom+ to HydDD	Phase B - etafilcon A with Tangible Coatings	1 week of DAILIES® AquaComfort PLUS® contact lenses followed by cross over to 1 week of Test HydDD contact lenses.
A2 - Moist to SiHyDD	Phase A - olifilcon B with Tangible Coatings	1 week of 1-DAY ACUVUE® Moist contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.
A3 - SiHyDD to OASDD	Phase A - olifilcon B with Tangible Coatings	1 week of Test SiHyDD contact lenses followed by cross over to 1 week of ACUVUE® OASYS 1-Day contact lenses.
B4 - BioTrue to HydDD	Phase B - etafilcon A with Tangible Coatings	1 week of BIOTRUE ONEday® contact lenses followed by cross over to 1 week of Test HydDD contact lenses.
A4 - OASDD to SiHyDD	Phase A - olifilcon B with Tangible Coatings	1 week of ACUVUE® OASYS 1-Day contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.
A5 - SiHyDD to DT1	Phase A - olifilcon B with Tangible Coatings	1 week of Test SiHyDD contact lenses followed by cross over to 1 week of Alcon DAILIES TOTAL 1® contact lenses.
B5 - HydDD to AqCom+	Phase B - etafilcon A with Tangible Coatings	1 week of Test HydDD contact lenses followed by cross over to 1 week of DAILIES® AquaComfort PLUS® contact lenses.
A6 - DT1 to SiHyDD	Phase A - olifilcon B with Tangible Coatings	1 week of Alcon DAILIES TOTAL 1® contact lenses followed by cross over to 1 week of Test SiHyDD contact lenses.
B3 - HydDD to BioTrue	Phase B - etafilcon A with Tangible Coatings	1 week of Test HydDD contact lenses followed by cross over to 1 week of BIOTRUE ONEday® contact lenses.

Primary Outcome Measures

Name	Time	Method
Subjective Lens Preference	Visit 3 - Approximately 2 weeks	Subjective preference for either lens intervention or no preference. Likert question with forced preference for Test or Benchmark lens or no preference.

Secondary Outcome Measures

Name	Time	Method
8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) score	Visit 2 and 3 - Approximately 1 and 2 weeks, respectively	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.

Trial Locations

Locations (6)

Ross Eyecare; 🇺🇸 Atlanta, Georgia, United States

Professional Eye Care Center; 🇺🇸 Niles, Illinois, United States

RevolutionEyes; 🇺🇸 Carmel, Indiana, United States

Professional VisionCare; 🇺🇸 Westerville, Ohio, United States

Andover Optometry on Central; 🇺🇸 Andover, Massachusetts, United States

Primary Eyecare Group, PC; 🇺🇸 Brentwood, Tennessee, United States