NCT04532099

Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the overall performance of an investigational silicone hydrogel lens when compared to ACUVUE OASYS® with HYDRACLEAR® PLUS (AOHP).

Detailed description

Part A of this study is a randomized, double masked, crossover study comparing 2 contact lens products. The expected duration of subject participation in Part A is approximately 8 weeks with 5 scheduled visits. Part B of this study is a non-randomized, single masked, single group study with 1 contact lens product. The expected duration of subject participation in Part B is approximately 4 weeks with 3 scheduled visits.

Conditions

• Refractive Errors
• Ametropia

Interventions

Type	Name	Description
DEVICE	Lehfilcon A contact lenses	Investigational soft contact lenses for daily wear worn in Part A of the study
DEVICE	Senofilcon A contact lenses	Commercially available soft contact lenses for daily wear worn in Part A of the study
DEVICE	Comfilcon A contact lenses	Commercially available soft contact lenses for daily wear worn in Part B of the study
DEVICE	Hydrogen peroxide-based cleaning and disinfecting solution	For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study

Timeline

• Start date: 2020-09-09
• Primary completion: 2021-05-04
• Completion: 2021-05-04
• First posted: 2020-08-31
• Last updated: 2022-05-03
• Results posted: 2022-05-03

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study