PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Care Provider)
  • Study Primary Completion Date: October 2019

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.

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

Arms, Groups and Cohorts

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Subjective Lens Preference
    • Time Frame: 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 Measures

  • 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) score
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 42 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Vision Service Plan
  • Collaborator
    • Foresight Regulatory Strategies, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Robin L Chalmers, OD, Principal Investigator, Clinical Trial Consultant
  • Overall Contact(s)
    • Robin L Chalmers, OD, 678-427-6986, chalmers2097@gmail.com

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