Contact Lens Solution for Refractive Errors

No longer recruiting at 21 trial locations
DD
Overseen ByDaniel Donatello
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Bausch & Lomb Incorporated
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two contact lens cleaning solutions, BL-3100-NBR03 multi-purpose solution and renu® Advanced Formula multi-purpose solution, to determine which is safer and more effective for daily use. Participants will use one of the solutions for three months while wearing contact lenses replaced monthly. It suits individuals who regularly wear soft contact lenses and clean them daily without hydrogen-peroxide-based solutions. As an unphased trial, this study allows participants to contribute to research that could enhance daily contact lens care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the BL-3100-NBR03 multi-purpose solution is currently being tested for safety. Specific information from past studies is lacking, so it is uncertain how well people tolerate it. As this is an early-stage trial, comprehensive safety data may not yet be available, and safety is still under evaluation.

In contrast, the renu® Advanced Formula multi-purpose solution is already available in stores, indicating it has been deemed safe for most people when used for cleaning and disinfecting contact lenses.

So far, there have been no major reports of side effects from either solution. However, participants should report any discomfort or issues during the trial.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the BL-3100-NBR03 multi-purpose solution because it promises to redefine how we clean and disinfect contact lenses. Unlike typical solutions that rely on well-known disinfectants, BL-3100-NBR03 might incorporate a novel combination of ingredients that enhance its cleaning power while being gentle on the eyes. This could mean fewer irritations and a more comfortable experience for contact lens wearers. Meanwhile, the renu® Advanced Formula serves as a trusted benchmark in the trial, known for its reliable cleaning performance and safety profile.

What evidence suggests that this trial's treatments could be effective for eye care?

This trial will compare the effectiveness of two contact lens solutions: BL-3100-NBR03 and renu® Advanced Formula. Studies have shown that contact lens solutions effectively clean and disinfect lenses by removing dirt and killing bacteria that can cause eye infections. Researchers are studying the BL-3100-NBR03 solution, which participants in this trial may receive, for its ability to clean and maintain lens comfort. Meanwhile, the renu® Advanced Formula, another treatment option in this trial, has a proven record of keeping lenses clean and comfortable while reducing eye irritation. Both products aim to ensure that lenses are safe and comfortable for daily use.16789

Who Is on the Research Team?

DD

Daniel Donatello

Principal Investigator

Bausch & Lomb Incorporated

Are You a Good Fit for This Trial?

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
See 7 more

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
See 20 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • BL-3100-NBR03 multi-purpose solution
  • renu® Advanced Formula multi-purpose solution
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: BL-3100-NBR03Experimental Treatment1 Intervention
Group II: renu® Advanced FormulaActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bausch & Lomb Incorporated

Lead Sponsor

Trials
263
Recruited
59,400+
Dr. Christina Ackermann profile image

Dr. Christina Ackermann

Bausch & Lomb Incorporated

Chief Medical Officer since 2023

MD from Harvard Medical School

Brent Saunders profile image

Brent Saunders

Bausch & Lomb Incorporated

Chief Executive Officer since 2023

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

Citations

NCT05565937 | A Study to Evaluate the Safety and ...A Study to Evaluate the Safety and Effectiveness of a Contact Lens Cleaning and Disinfecting Solution ... Device : BL-3100-NBR03 multi-purpose solution; Device : ...
A Study to Evaluate the Safety and Effectiveness ...This N/A medical study run by Bausch & Lomb Incorporated needs participants to evaluate whether BL-3100-NBR03 multi-purpose solution and renu® Advanced ...
H. Lee Moffitt Cancer Center and Research Institute TrialsUS. BL-3100-NBR03 multi-purpose solution, renu® Advanced Formula multi-purpose solution. Bausch & Lomb Incorporated. Refractive Ametropia. 02/24. 02/24 ...
SAFETYWARE NBR03- NitraGuard™ Nitrile Coated GlovesProvides excellent protection against abrasion, cut, snag, puncture, oil & grease. NBR03. Visit our online stores: Categories: Coated Gloves, General Purpose ...
Cleanroom Compa ble Nitrile Gloves - ZoroCleanroom Compa ble Nitrile Gloves designed for use in par cle sensi ve and low contaminate environments. These gloves feature a rolled cuff, ...
Safety Data SheetsThe Safety Data Sheets (SDS) are intended to provide health, safety and environmental information for the people handling these products in the workplace.
Kannarr Eye Care TrialsBL-3100-NBR03 multi-purpose solution, renu® Advanced Formula multi-purpose solution. Bausch & Lomb Incorporated. Refractive Ametropia. 02/24. 02/24. NCT05660577 ...
SAFETYWARE NBR03- NitraGuard™ Nitrile Coated GlovesFull nitrile coated on cotton jersey shell; Canvas safety cuff helps to put on and take off; Offer superior protection when handling rough and abrasive object ...
SAFETY DATA SHEET - Staples.comThis product, when diluted as stated on the label, is not classified as hazardous according to 2012 OSHA Hazard Communication. Standard (29 CFR ...
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