Bimatoprost Solutions for Glaucoma

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Amneal Pharmaceuticals, LLC

Must be taking: Parasympathomimetics, Carbonic anhydrase inhibitors

Must not be taking: Corticosteroids, High-dose salicylates

Disqualifiers: Pregnancy, Severe hepatic impairment, Uncontrolled systemic disease, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

A randomized, double-blind, parallel-group, two-arm, multiple dose, multicenter, clinical endpoint bioequivalence study

Will I have to stop taking my current medications?

Participants will need to stop taking their current ocular hypotensive medications (medications that lower eye pressure) and undergo a washout period (time without taking certain medications) before starting the trial. However, the investigator may substitute certain medications during this period to minimize risk.

What data supports the effectiveness of the drug Bimatoprost for treating glaucoma?

Research shows that Bimatoprost is effective in lowering eye pressure in patients with glaucoma or high eye pressure, often more so than other treatments like timolol and similar to or better than latanoprost and travoprost. It works by increasing the outflow of fluid from the eye, and it has been shown to provide sustained pressure reduction over long-term use. ^{1 2 3 4 5}

Is bimatoprost generally safe for human use?

Bimatoprost is generally well tolerated in humans, with common side effects including mild eye redness, eyelash growth, and itching. Some people may also experience changes in eye color and skin around the eyes. ^{1 2 3 5 6}

How is the drug Bimatoprost unique in treating glaucoma?

Bimatoprost is unique because it is a synthetic prostamide that effectively lowers eye pressure by increasing fluid outflow, and it can be administered as a once-daily eye drop or as a sustained-release implant that lasts 4 to 6 months. This makes it more convenient and potentially more effective than some other treatments, which may require more frequent dosing. ^{1 2 3 5 6}

Research Team

Eligibility Criteria

This trial is for people with chronic open-angle glaucoma or ocular hypertension in both eyes. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and not be on conflicting medications.

Inclusion Criteria

Women of childbearing potential practicing acceptable methods of contraception

Subjects willing and able to provide voluntary informed consent and to follow protocol requirements

I need treatment for both eyes and can stop or switch my eye pressure medication after a washout period.

Exclusion Criteria

Use of contact lens within 1 week prior to baseline

History of recurrent ocular seasonal allergies within the past 2 years

I had eye surgery to correct vision or reduce eye pressure within the last year.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

Washout

Participants undergo a washout period based on their current medication

4 days to 4 weeks

Treatment

Participants receive either the test product or reference product for 6 weeks

6 weeks

Visits at Day 14 and Day 42

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bimatoprost Ophthalmic Solution (Prostaglandin Analog)

Trial Overview The study is testing the effectiveness of a Bimatoprost Ophthalmic Solution against LUMIGAN®, which is an established treatment. Participants will be randomly assigned to one of two groups, receiving either the test solution or LUMIGAN® without knowing which one they're getting.

Participant Groups

Group I: Bimatoprost Ophthalmic Solution, 0.01% Experimental Treatment 1 Intervention

Test Product: Bimatoprost Ophthalmic Solution, 0.01%

Group II: LUMIGAN® (bimatoprost ophthalmic solution) 0.01% Active Control 1 Intervention

Reference Product: LUMIGAN® (bimatoprost ophthalmic solution) 0.01%

Who Is Running the Clinical Trial?

Amneal Pharmaceuticals, LLC

Lead Sponsor

Trials

13

Recruited

28,500+

CBCC Global Inc.

Collaborator

Trials

1

Recruited

240+

Amneal EU, Limited

Collaborator

Trials

1

Recruited

240+

Findings from Research

In a two-month study involving 1283 patients, bimatoprost significantly lowered intraocular pressure (IOP) by an average of 3.4 mm Hg, with the percentage of patients achieving target pressures of ≤18 mm Hg doubling from 33% to 66%.

Bimatoprost was well-tolerated, with conjunctival hyperemia being the most common side effect (3.7%), indicating it is a safe and effective alternative to latanoprost for managing glaucoma and ocular hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocular hypotensive efficacy of bimatoprost when used as a replacement for latanoprost in the treatment of glaucoma and ocular hypertension. Bournias, TE., Lee, D., Gross, R., et al.[2018]

In a study of 6,767 patients with glaucoma or ocular hypertension, bimatoprost 0.03% monotherapy significantly lowered intraocular pressure (IOP) by an average of 7.5 mmHg (30%) after 2 months, demonstrating its efficacy in untreated patients.

Bimatoprost was well tolerated, with 41.5% of patients achieving target IOPs of ≤15 mmHg and 75.8% reaching ≤18 mmHg, although the most common side effect reported was conjunctival hyperemia (7.9%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of bimatoprost 0.03 percent in untreated glaucoma and ocular hypertension patients: results from a large community-based clinical trial. Quinones, R., Severin, T., Mundorf, T.[2015]

Bimatoprost 0.03% ophthalmic solution effectively reduces intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, showing better long-term results than timolol over a treatment period of up to 48 months.

The treatment is well tolerated, with common side effects including mild conjunctival hyperemia and eyelash growth, while also demonstrating similar or superior efficacy compared to other prostaglandin analogues like latanoprost and travoprost.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimatoprost: a review of its use in open-angle glaucoma and ocular hypertension. Curran, MP.[2021]

Bimatoprost and travoprost are more effective than timolol in lowering intraocular pressure (IOP) in patients with glaucoma and are as effective as latanoprost, based on recent comparative studies.

While the side effects of bimatoprost, latanoprost, and travoprost are generally similar, bimatoprost and travoprost are associated with higher rates of hyperemia (redness of the eye) and eyelash growth compared to latanoprost and timolol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimatoprost and travoprost: a review of recent studies of two new glaucoma drugs. Eisenberg, DL., Toris, CB., Camras, CB.[2019]

The bimatoprost implant (Durysta™) is a biodegradable drug delivery system that provides sustained release of bimatoprost to lower intraocular pressure (IOP) for 4 to 6 months, making it a convenient treatment option for patients with open angle glaucoma or ocular hypertension.

Approved in March 2020, the implant represents a significant advancement in glaucoma treatment, allowing for prolonged IOP control without the need for daily eye drops, and its clinical development is still ongoing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimatoprost Implant: First Approval. Shirley, M.[2020]

Bimatoprost is a highly effective medication for lowering intraocular pressure in patients with glaucoma and ocular hypertension, providing consistent control throughout the day.

As a synthetic molecule similar to prostamide F(2), bimatoprost mimics prostamide activity, which contributes to its strong ocular hypotensive effects and indicates its unique pharmacological properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical pharmacology of bimatoprost. Cantor, LB.[2019]

References

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

Ocular hypotensive efficacy of bimatoprost when used as a replacement for latanoprost in the treatment of glaucoma and ocular hypertension. [2018]

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

Efficacy of bimatoprost 0.03 percent in untreated glaucoma and ocular hypertension patients: results from a large community-based clinical trial. [2015]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Bimatoprost: a review of its use in open-angle glaucoma and ocular hypertension. [2021]

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

Bimatoprost and travoprost: a review of recent studies of two new glaucoma drugs. [2019]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Bimatoprost Implant: First Approval. [2020]

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

Clinical pharmacology of bimatoprost. [2019]