NCT04032457

PAVES Benchmarking Pilot Study of Daily Disposable Contact Lenses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Vision Service Plan · Industry
• Sex: All
• Age: 18 Years – 42 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Refractive Errors

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-03-15
• Primary completion: 2019-08-02
• Completion: 2019-08-02
• First posted: 2019-07-25
• Last updated: 2020-10-06

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study