Evaluation of Brimonidine Tartrate/Ketotifen Fumarate Combination for the Treatment of Allergic Conjunctivitis

Recruiting at 3 trial locations

Overseen By Dan Donatello

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Bausch & Lomb Incorporated

Must not be taking: Antihistamines, Decongestants, Corticosteroids, NSAIDs

Disqualifiers: Glaucoma, Retinal disease, Infections, others

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: 4

Duration: 15 days

188 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new eye drop that combines two drugs to treat eye allergies. It aims to see if the combination works better than each drug alone. The treatment targets people with allergic conjunctivitis, aiming to reduce redness and itching.

Will I have to stop taking my current medications?

The trial requires you to stop taking certain medications before and during the study. Specifically, you must stop using certain antihistamines, decongestants, and other listed medications for 7 days before the trial, corticosteroids for 14 days, and some other medications for longer periods. Baby aspirin is allowed if you've been on a stable dose for at least 30 days.

What data supports the effectiveness of the drug Brimonidine tartrate 0.025% / ketotifen fumarate 0.035% combo?

Research shows that ketotifen fumarate is effective in preventing eye itching due to allergies, and brimonidine is used to lower eye pressure in glaucoma. While the specific combination hasn't been directly studied, the individual components have proven benefits for eye conditions. ^{1 2 3 4 5}

Is the combination of Brimonidine tartrate 0.025% and Ketotifen fumarate 0.035% safe for humans?

Brimonidine tartrate 0.025% has been studied for safety in treating eye redness, and while generally safe, ingestion of higher concentrations (0.2%) can cause serious symptoms if swallowed, as seen in a case with a child. Long-term use of brimonidine can also lead to eye inflammation in some cases. ^{4 6 7 8 9}

How does the drug Brimonidine tartrate 0.025% / ketotifen fumarate 0.035% combo differ from other treatments?

This drug combines brimonidine, which is typically used to lower eye pressure in glaucoma, with ketotifen, an antihistamine that prevents itching from allergies. The combination may offer a unique dual action by addressing both eye pressure and allergic symptoms, which is not commonly found in single treatments. ^{1 3 4 7 10}

Eligibility Criteria

Inclusion Criteria

Subjects must be at least 10 years of age of either sex and any race

If male and with female partner of childbearing potential, subjects must use at least 1 medically acceptable form of birth control throughout the study duration, for at least 14 days prior to the first dose of investigational drug (Visit 4a) and for 1 month after the last dose of the study drug (Visit 5). Note: Acceptable forms of birth control are true abstinence (when this is in line with the preferred and usual lifestyle of the subject) or vasectomy at least 3 months prior to the first dose of investigational drug (Visit 4a). Without a vasectomy, subjects must use condoms with spermicidal foam/gel/film/cream/suppository

Subjects must be able and willing to discontinue wearing contact lenses for at least 72 hours prior to Visit 2 and during the study trial period

Exclusion Criteria

Subjects may not have had ocular surgical intervention within 3 months prior to enrollment (Visit 4a) and/or a history of refractive surgery within 6 months prior to enrollment (Visit 4a)

You shouldn't have a history of retinal detachment, diabetic retinopathy, or any worsening eye diseases.

Subjects may not use inhaled, ocular, topical, or systemic corticosteroids or mast cell stabilizers for 45 days, depo-corticosteroids for 2 months, or immunosuppressive or cancer chemotherapeutic agents

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study medication and are assessed for ocular itching and conjunctival redness

15 days

Multiple visits including Visit 4b on day 1 and Visit 5 on day 15

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Brimonidine tartrate 0.025% / ketotifen fumarate 0.035% combo
• Brimonidine tartrate ophthalmic solution 0.025%
• Ketotifen fumarate ophthalmic solution 0.035%

Participant Groups

Group I: Combination Experimental Treatment 1 Intervention

Brimonidine tartrate 0.025%/ketotifen fumarate 0.035% combination ophthalmic solution

Group II: Ketotifen fumarate Active Control 1 Intervention

ketotifen fumarate 0.035% ophthalmic solution

Group III: Brimonidine tartrate Active Control 1 Intervention

brimonidine tartrate 0.025% ophthalmic solution

Group IV: Vehicle Placebo Group 1 Intervention

vehicle ophthalmic 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

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]

References

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

A comparison of the relative clinical efficacy of a single dose of ketotifen fumarate 0.025% ophthalmic solution versus placebo in inhibiting the signs and symptoms of allergic rhinoconjunctivitis as induced by the conjunctival allergen challenge model. [2019]

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

12-week study comparing the fixed combination of brimonidine and timolol with concomitant use of the individual components in patients with glaucoma and ocular hypertension. [2017]

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

Bioequivalence of two formulations of ketotifen fumarate ophthalmic solution: a single-center, randomized, double-masked conjunctival allergen challenge investigation in allergic conjunctivitis. [2019]

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

Clinical effects of brimonidine ophthalmic drops ingestion in 52 dogs. [2015]

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

12-week study comparing the fixed combination of brimonidine and timolol with concomitant use of the individual components in patients with glaucoma and ocular hypertension. [2019]

6. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

Adrenoceptor agonist poisoning after accidental oral ingestion of brimonidine eye drops. [2019]

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

Effect of Brimonidine on the B Cells, T Cells, and Cytokines of the Ocular Surface and Aqueous Humor in Rat Eyes. [2015]

10. India pubmed.ncbi.nlm.nih.gov

Fluorimetric quantification of brimonidine tartrate in eye drops. [2021]