"Efficacy and Safety of Brimonidine Tartrate Preservative-Free Formulation in Adults With Ocular Redness"

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

380 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two types of eye drops to see which one is better at reducing eye redness. It involves people who have red eyes and works by shrinking the blood vessels in their eyes to make them look less red.

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.

What data supports the effectiveness of the drug Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation, Lumify®?

Research shows that preservative-free brimonidine tartrate is effective in reducing intraocular pressure (IOP) in conditions like glaucoma and ocular hypertension, with similar effectiveness to preserved formulations. Additionally, it provides better tear film stability and higher patient satisfaction. ^{1 2 3 4 5}

Is brimonidine tartrate ophthalmic solution 0.025% safe for use in humans?

Brimonidine tartrate ophthalmic solution 0.025% has been studied for safety in treating ocular redness and other eye conditions. It is generally well-tolerated, though some people may experience mild discomfort like burning or stinging. Both preservative-free and preserved versions have shown similar safety profiles, with the preservative-free version sometimes causing a bit more burning sensation initially. ^{1 2 3 6 7}

How is preservative-free brimonidine tartrate 0.025% unique compared to other drugs for eye conditions?

Preservative-free brimonidine tartrate 0.025% is unique because it does not contain preservatives, which can lead to better tear-film stability and higher patient satisfaction compared to preserved formulations. This can be particularly beneficial for patients with sensitive eyes or those who experience discomfort from preservatives in other eye drops. ^{1 2 4 8 9}

Research Team

Daniel Donatello

Principal Investigator

Bausch & Lomb Incorporated

Eligibility Criteria

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

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

Treatment Details

Interventions

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

Participant Groups

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

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparisons of efficacy and safety between preserved and preservative-free brimonidine tartrate in glaucoma and ocular hypertension: a parallel-grouped, randomized trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Preservative-free versus preserved brimonidine %0.15 preparations in the treatment of glaucoma and ocular hypertension: short term evaluation of efficacy, safety, and potential advantages. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Evaluation of Efficacy and Safety of Brimonidine Tartrate Ophthalmic Solution, 0.025% for Treatment of Ocular Redness. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of brimonidine tartrate 0.15% on night-vision difficulty and contrast testing after refractive surgery. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy of brimonidine 0.2% in controlling acute postoperative intraocular pressure elevation after phacoemulsification. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Low-dose brimonidine for relief of ocular redness: integrated analysis of four clinical trials. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Delayed hypersensitivity to brimonidine tartrate 0.2% associated with high intraocular pressure. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Formulation effects on ocular absorption of brimonidine in rabbit eyes. [2015]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Ocular Distribution of Brimonidine and Brinzolamide after Topical Instillation of a 0.1% Brimonidine Tartrate and 1% Brinzolamide Fixed-Combination Ophthalmic Suspension: An Interventional Study. [2023]