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

Recruiting at 19 trial locations

Overseen By Daniel Donatello

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bausch & Lomb Incorporated

Must not be taking: Ocular medications

Disqualifiers: Pregnancy, Breastfeeding, Ocular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

296 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial involves 340 participants who will wear special contact lenses daily for a period of time. The lenses will be replaced regularly to test their effectiveness and safety.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but you cannot participate if you are using any medications that affect eye health or contact lens performance.

Research Team

Daniel Donatello

Principal Investigator

Bausch & Lomb Incorporated

Eligibility Criteria

Inclusion Criteria

Is a habitual wearer (at least 3 months)

Requires lens correction in both eyes

Has typically cleaned and disinfected their pre-study contact lenses daily

Exclusion Criteria

Participated in any drug or device clinical investigation within 30 days prior to entry into this study

Has ocular astigmatism of 1.00D or greater in either eye

Is currently using a hydrogen-peroxide cleaning and disinfecting solution

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants 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

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BL-3100-NBR03 multi-purpose solution
• renu® Advanced Formula multi-purpose solution

Participant Groups

Group I: BL-3100-NBR03 Experimental Treatment 1 Intervention

BL-3100-NBR03 multi-purpose solution

Group II: renu® Advanced Formula Active Control 1 Intervention

renu® Advanced Formula multi-purpose solution

Who Is Running the Clinical Trial?

Bausch & Lomb Incorporated

Lead Sponsor

Trials

263

Recruited

59,400+

Dr. Christina Ackermann

Bausch & Lomb Incorporated

Chief Medical Officer since 2023

MD from Harvard Medical School

Brent Saunders

Bausch & Lomb Incorporated

Chief Executive Officer since 2023

BA from the University of Pittsburgh, JD and MBA from Temple University