Brimonidine Tartrate for Red Eye

No longer recruiting at 5 trial locations

Overseen By Daniel Donatello

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bausch & Lomb Incorporated

Must be taking: Vasoconstrictors

Must not be taking: Ocular antihistamines, Systemic corticosteroids

Disqualifiers: Ocular infection, Ocular surgery, Glaucoma, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a preservative-free eye drop (brimonidine tartrate ophthalmic solution 0.025%) in reducing eye redness compared to Lumify®. Researchers aim to determine if the new formulation is both effective and safe for frequent users of redness relief eye drops. Participants with ongoing eye redness who can self-administer eye drops may be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the availability of a potential new treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop using certain medications before and during the trial. Specifically, you must stop using all topical eye medications 5 days before, systemic antihistamines or decongestants 7 days before, and systemic corticosteroids or certain other systemic medications 14 days before the trial.

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

Research has shown that brimonidine tartrate, in a preservative-free form, is generally safe and well-tolerated. Studies have found that a 0.025% solution can reduce eye redness for at least four hours. Importantly, no reports indicate that the body becomes accustomed to the drug over time, which would reduce its effectiveness, or that symptoms worsen after stopping the treatment. While some sensitive individuals might experience minor eye irritation, this is uncommon. Overall, the treatment is considered effective and safe for managing eye redness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the preservative-free formulation of Brimonidine tartrate because it offers a new option for reducing ocular redness without the added preservatives found in standard treatments like Lumify®. Preservatives in eye drops can sometimes cause irritation or discomfort, especially for people with sensitive eyes. By eliminating these preservatives, the new formulation may provide a gentler alternative while maintaining the effective redness-reducing properties of Brimonidine tartrate. This could lead to enhanced comfort and potentially broader use among individuals who are sensitive to preservatives in eye medications.

What evidence suggests that this trial's treatments could be effective for ocular redness?

Research shows that brimonidine tartrate eye drops (0.025%) effectively reduce eye redness. Studies have found that the drops target specific parts of the eye to lessen redness for at least four hours. In this trial, participants will receive either the preservative-free formulation or Lumify®, which contains preservatives. Both types are safe and well-tolerated, with no major side effects such as increased redness after stopping use. This preservative-free option is available for those who prefer it. ^{3 6 7 8 9}

Who Is on the Research Team?

Daniel Donatello

Principal Investigator

Bausch & Lomb Incorporated

Are You a Good Fit for This Trial?

Inclusion Criteria

You have used redness relief eye drops in the past 6 months or you want to use over-the-counter eye drops for redness relief.

(If female and of childbearing potential) agree to have urine pregnancy testing performed at Visit 1 (must be negative) and at exit visit; must not be lactating; and must agree to use at least 1 medically acceptable form of birth control2 throughout the study duration and for at least 14 days prior to the first dose of study drug (Visit 1) and for 1 month after the last dose of investigational drug

(If male and with female partner of childbearing potential) must use at least 1 medically acceptable form of birth control3

Exclusion Criteria

Have the presence of an active ocular infection (bacterial, viral, or fungal) or positive history of an ocular herpetic infection at any visit

Have prior (within 30 days of beginning investigational drug) or anticipated concurrent use of an investigational drug or device during the study period

Have an ocular or systemic condition or a situation which, in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation or Lumify® for approximately 4 weeks

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation
• Lumify® (brimonidine tartrate ophthalmic solution 0.025%)

How Is the Trial Designed?

Group I: Brimonidine tartrate preservation-free Experimental Treatment 1 Intervention

Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation

Group II: Lumify® Active Control 1 Intervention

Lumify® (brimonidine tartrate ophthalmic solution 0.025%)

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

Published Research Related to This Trial

Brimonidine tartrate ophthalmic solution 0.15% significantly improved low-contrast visual acuity and contrast sensitivity in patients experiencing night-vision difficulties after laser refractive surgery, with effects observed as soon as one hour after administration.

After one month of treatment, all six patients reported subjective improvements in their night vision, indicating that brimonidine tartrate can provide lasting benefits for up to a month post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of brimonidine tartrate 0.15% on night-vision difficulty and contrast testing after refractive surgery. Edwards, JD., Burka, JM., Bower, KS., et al.[2015]

Brimonidine tartrate ophthalmic solution 0.025% significantly reduced ocular redness compared to a vehicle, with a mean change of -1.4 units versus -0.2 units at all assessed time points on Day 1, indicating its efficacy as a topical treatment.

The treatment showed a good safety profile with low incidence of adverse events, minimal rebound redness, and no evidence of tachyphylaxis, making it a well-tolerated option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose brimonidine for relief of ocular redness: integrated analysis of four clinical trials. Ackerman, SL., Torkildsen, GL., McLaurin, E., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12370570/

A Multicenter Randomized Double-Masked Study ... Brimonidine tartrate ophthalmic solution 0.025% (LUMIFY® 0.025%) is the first selective α2-AR agonist approved to treat ocular redness [1]. As ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/02713683.2017.1381269

Evaluation of Efficacy and Safety of Brimonidine Tartrate ... Conclusions: Brimonidine 0.025% appeared safe, well tolerated, and reduced ocular redness for at least 4 hours. No tachyphylaxis or rebound ...

3. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2025/218424Orig1s000MedR.pdf

218424Orig1s000 CLINICAL REVIEW(S) - accessdata.fda.gov Brimonidine tartrate ophthalmic solution 0.025% “preservative free” is recommended for approval for relief of redness of the eye due to minor.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40711722/

A Multicenter Randomized Double-Masked Study ... Conclusions: BTOS-PF 0.025% was non-inferior to LUMIFY 0.025% in reducing ocular redness in adults, was well-tolerated, and offers an ...

5. cochranelibrary.com cochranelibrary.com/content?templateType=related&urlTitle=/central/doi/10.1002/central/CN-01704227&doi=10.1002/central/CN-01704227&p_p_id=scolariscontentdisplay_WAR_scolariscontentdisplay&_scolariscontentdisplay_WAR_scolariscontentdisplay_action=related-content&p_p_lifecycle=0&p_p_mode=view&type=central&contentLanguage=

Evaluation of Efficacy and Safety of Brimonidine Tartrate ... Low-dose brimonidine for relief of ocular redness: integrated analysis of four clinical trials · Brimonidine Ophthalmic Solution 0.025% for Reduction of Ocular ...

6. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ef5974b9-946c-4983-80e3-32b3aa28c207

LUMIFY PRESERVATIVE FREE EYE DROPS- brimonidine ... Active ingredient: Brimonidine tartrate (0.025%). Purpose: Redness reliever. Warnings: For external use only. Keep out of reach of children.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2025/218424Orig1s000OtherR.pdf

218424Orig1s000 - accessdata.fda.gov The Applicant intends for the proposed preservative-free formulation of brimonidine tartrate ophthalmic solution, 0.025% to contain all the same.

8. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_AKORN_17478071510_17478071511_17478071512_BRIMONIDINE_TARTRATE_OPHTHALMIC_SOLUTION_02PERCENT.pdf

SDS: Brimonidine Tartrate Ophthalmic Solution, 0.2% Hazards Not Otherwise Classified: Not classifiable. Supplementary Information: While this material is not classifiable as hazardous under the OSHA standard, ...

9. cf1.bettymills.com cf1.bettymills.com/product/MSDS/MON1117410EA.PDF

Safety Data Sheet Section 1: Identification Product ... May cause eye irritation in sensitive individuals. Lumify™(brimonidine tartrate ophthalmic solution 0.025%). Preparation Date: 25/August/2017. Revision Date: 04 ...