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PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses

NCT04032457 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2020-10-06

No results posted yet for this study

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.

Conditions

  • Refractive Errors

Interventions

DEVICE

Phase A - olifilcon B with Tangible Coatings

Daily disposable silicone hydrogel contact lens

DEVICE

Phase B - etafilcon A with Tangible Coatings

Daily disposable hydrogel contact lens

Sponsors & Collaborators

  • Foresight Regulatory Strategies, Inc.

    collaborator INDUSTRY

  • Vision Service Plan

    lead INDUSTRY

Principal Investigators

  • Robin L Chalmers, OD · Clinical Trial Consultant

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2019-08-02
Completion
2019-08-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04032457 on ClinicalTrials.gov