NCT03920280

Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to demonstrate 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 randomized to wear either the investigational contact lenses or the commercially available contact lenses in both eyes. Subjects will be expected to attend 6 scheduled study visits. Individual participation in the study will be approximately 3 months.

Conditions

• Refractive Errors

Interventions

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

Timeline

• Start date: 2019-05-22
• Primary completion: 2019-10-05
• Completion: 2019-10-05
• First posted: 2019-04-18
• Last updated: 2022-07-28
• Results posted: 2022-02-01

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study