NCT04422990

Clinical Evaluation of a Silicone Hydrogel Daily Wear Monthly Replacement Contact Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to evaluate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.

Detailed description

Subjects will be expected to attend 4 office visits: Screening/Baseline/Dispense, Week 1 Follow-up, Month 1 Follow-up, and Month 3 Follow-up/Exit. The total expected duration of participation for each subject is approximately 3-4 months in this daily wear clinical study.

Conditions

• Refractive Errors

Interventions

Type	Name	Description
DEVICE	Lehfilcon A contact lenses	Investigational silicone hydrogel contact lenses
DEVICE	Comfilcon A contact lenses	Commercially available silicone hydrogel contact lenses
DEVICE	CLEAR CARE	Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-02-22
• Completion: 2021-05-18
• First posted: 2020-06-09
• Last updated: 2022-03-29
• Results posted: 2022-02-24

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated device study