NCT04055519

Clinical Performance Assessment of a Daily Wear Monthly Replacement Soft Silicone Hydrogel Contact Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to obtain on-eye performance data to inform contact lens product development.

Detailed description

Subjects are expected to attend 5 scheduled visits. The expected duration of subject participation in the study is approximately 60 days, with approximately 30 days (± 2 days) per product.

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	Multi-purpose disinfection solution	Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses

Timeline

• Start date: 2019-09-19
• Primary completion: 2019-12-03
• Completion: 2019-12-03
• First posted: 2019-08-13
• Last updated: 2021-05-13
• Results posted: 2021-05-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study