PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses

Not Applicable

Completed

• Conditions: Refractive Errors

• 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

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

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

Professional VisionCare; 🇺🇸 Westerville, Ohio, United States

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