PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses

Vision Service Plan144 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

144

Conditions

Refractive Errors

Interventions

Phase A - olifilcon B with Tangible CoatingsDEVICE

Daily disposable silicone hydrogel contact lens

Phase B - etafilcon A with Tangible CoatingsDEVICE

Daily disposable hydrogel contact lens

Eligibility

Sex: ALLMin age: 18 YearsMax age: 42 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

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.

Time frame: Visit 3 - Approximately 2 weeks

Secondary Outcomes

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.

Time frame: Visit 2 and 3 - Approximately 1 and 2 weeks, respectively

Data from ClinicalTrials.gov

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