NCT05565937

A Study to Evaluate the Safety and Effectiveness of a Contact Lens Cleaning and Disinfecting Solution

A Safety and Effectiveness Study of a Contact Lens Cleaning and Disinfecting Solution

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 295 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Approximately 340 participants (680 eyes) will be enrolled in this three-month, two-arm, 1:1 randomized, parallel-group, bilateral, double-masked study at approximately 22 investigative sites in the United States. Participants will be required to wear dispensed study lenses on a daily wear basis for three months with scheduled in-office replacement of study lenses at the 1-Month and 2-Month Follow-Up Visits.

Conditions

• Refractive Ametropia

Interventions

Type	Name	Description
DEVICE	BL-3100-NBR03 multi-purpose solution	BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses
DEVICE	renu® Advanced Formula multi-purpose solution	renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses

Timeline

• Start date: 2023-04-12
• Primary completion: 2024-02-28
• Completion: 2024-02-28
• First posted: 2022-10-04
• Last updated: 2025-05-20
• Results posted: 2025-05-20

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated device study