NCT03897712

A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens When Compared to Alden Optical HP Sphere Lens

A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study is to evaluate the safety and efficacy of Bausch + Lomb custom samfilcon B (test) lens compared to the hioxifilcon D, 54% water, Alden Optical HP Sphere (control) lens when worn by participants who wear soft contact lens on a daily basis.

Conditions

• Contact Lens Wear

Interventions

Type	Name	Description
DEVICE	Custom Samfilcon B Contact Lenses	Contact lens
DEVICE	Alden Optical HP Sphere Contact Lens	Hioxifilcon D, 54% water, Alden Optical HP Sphere lens
DEVICE	ReNu MultiPlus Lubricating and Rewetting Drops	For use as needed during the study.
DEVICE	Biotrue Multi-Purpose Solution	For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study.

Timeline

• Start date: 2019-02-27
• Primary completion: 2019-08-28
• Completion: 2019-08-28
• First posted: 2019-04-01
• Last updated: 2022-11-14
• Results posted: 2022-10-26

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study