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OpenTrials
Completed

NCT Number: NCT04032457

PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses

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.

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Key information

Conditions

Refractive Errors Eye Diseases

Age range

18 year–42 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ross Eyecare, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phase A - olifilcon B with Tangible Coatings

Device

Daily disposable silicone hydrogel contact lens

Phase B - etafilcon A with Tangible Coatings

Device

Daily disposable hydrogel contact lens

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Vision Service Plan

Industry

Collaborators

  • Foresight Regulatory Strategies, Inc.

Registry information

Acronym: PAVES

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 25, 2019
Registry last updated
Oct 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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