NCT04178720

Clinical Evaluation of a Daily Wear Monthly Replacement Silicone Hydrogel Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 119 (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 effectiveness of an investigational soft contact lens compared to a commercially available soft contact lens when worn for daily wear and replaced monthly.

Detailed description

Subjects are expected to attend 6 study visits. The expected duration of study lens exposure is approximately 3 months.

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 system for cleaning and disinfecting silicone hydrogel contact lenses

Timeline

• Start date: 2020-01-28
• Primary completion: 2020-06-10
• Completion: 2020-06-10
• First posted: 2019-11-26
• Last updated: 2021-10-19
• Results posted: 2021-05-13

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study