Brimonidine + Ketotifen for Allergic Eye

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new eye drop solution for individuals with allergic conjunctivitis, which causes red, itchy eyes. Researchers aim to determine if a combination of two drugs, brimonidine tartrate (an alpha agonist) and ketotifen fumarate (an antihistamine), is more effective than each drug alone or a placebo (an inactive solution). Individuals with a history of eye allergies and a positive skin test for specific allergens, such as pollen or pet dander, may be suitable candidates. The study seeks to identify which treatment provides the most relief from allergy symptoms. As a Phase 3 trial, this treatment is in the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in allergy relief.

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.

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

Research shows that eye drops containing brimonidine tartrate and ketotifen fumarate are generally safe. Brimonidine tartrate 0.025% commonly reduces eye redness and is usually well-tolerated, though some people might experience mild eye irritation. Serious side effects, such as decreased vision, occur in about 1-4% of users.

Ketotifen fumarate 0.035% is also safe and effectively treats eye allergies. As an antihistamine, it helps stop eye itching and typically does not cause health issues.

Both ingredients have been studied separately and are approved for different uses, supporting their safety. The current study phase gathers more safety information, demonstrating confidence in the treatment's tolerability. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the brimonidine tartrate/ketotifen fumarate combination treatment for allergic conjunctivitis because it targets the condition in a novel way. While standard treatments typically focus on either reducing allergy symptoms or shrinking blood vessels in the eye, this combo does both. Ketotifen fumarate is an antihistamine that tackles itching by blocking histamine receptors, while brimonidine tartrate reduces redness by constricting blood vessels. This dual-action approach offers the potential for more comprehensive and faster relief compared to treatments that address just one aspect of the condition.

What evidence suggests that this trial's treatments could be effective for allergic conjunctivitis?

Research has shown that ketotifen fumarate helps prevent eye itching from allergies, while brimonidine often reduces eye pressure in people with glaucoma. This trial explores a combination of brimonidine tartrate 0.025% and ketotifen fumarate 0.035% for treating allergic conjunctivitis. Participants may receive this combination treatment. Early results suggest this combination might outperform each ingredient alone. The goal is to determine if it can more effectively relieve both itching and redness, providing better relief for allergy sufferers. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

How Is the Trial Designed?

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

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05591755

Evaluation of Brimonidine Tartrate/Ketotifen Fumarate ... To evaluate the efficacy of Combo compared to its individual components and compared to vehicle in a population of subjects with seasonal allergic ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05815758

Study Details | NCT05815758 | Evaluation of the Safety ... The study will consist of 4-5 study visits to compare the safety and tolerability of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% combination ...

3. ctv.veeva.com ctv.veeva.com/study/evaluation-of-brimonidine-tartrate-ketotifen-fumarate-combination-for-the-treatment-of-allergic-conj

Evaluation of Brimonidine Tartrate/Ketotifen Fumarate ... To evaluate the efficacy of Combo (Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution) compared to its individual ...

4. withpower.com withpower.com/trial/phase-3-conjunctivitis-9-2022-46c1b

Evaluation of Brimonidine Tartrate/Ketotifen Fumarate ... 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 ...

5. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT05579730/

Trial | NCT05579730 To evaluate the efficacy of Combo (Drug Product Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution) compared to its individual ...

6. 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, ...