NCT04207749

Clinical Evaluation of a Daily Wear Silicone Hydrogel Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to assess 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 with frequent replacement.

Detailed description

Subjects will 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 months.

Conditions

• Refractive Errors
• Myopia
• Hyperopia

Interventions

Type	Name	Description
DEVICE	LID015385 contact lenses	Investigational soft contact lenses
DEVICE	Comfilcon A contact lenses	Commercially available soft contact lenses
DEVICE	CLEAR CARE	Hydrogen peroxide-based cleaning and disinfecting solution

Timeline

• Start date: 2020-01-22
• Primary completion: 2020-12-17
• Completion: 2020-12-17
• First posted: 2019-12-23
• Last updated: 2022-02-02
• Results posted: 2022-02-02

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated device study