PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses

Refractive Errors Clinical Trial

— PAVES  

Official title:

PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04032457
• Other study ID #: VS-19-01
• Status: Completed
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: August 2, 2019

Study information

• Verified date: October 2020
• Source: Vision Service Plan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: August 2, 2019
• Est. primary completion date: August 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• Phase A - olifilcon B with Tangible Coatings
Daily disposable silicone hydrogel contact lens
• Phase B - etafilcon A with Tangible Coatings
Daily disposable hydrogel contact lens

Locations

Country	Name	City	State
United States	Andover Optometry on Central	Andover	Massachusetts
United States	Ross Eyecare	Atlanta	Georgia
United States	Primary Eyecare Group, PC	Brentwood	Tennessee
United States	RevolutionEyes	Carmel	Indiana
United States	Professional Eye Care Center	Niles	Illinois
United States	Professional VisionCare	Westerville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Vision Service Plan	Foresight Regulatory Strategies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Visit 3 - Approximately 2 weeks
Secondary	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.	Visit 2 and 3 - Approximately 1 and 2 weeks, respectively