Bimatoprost Solutions for Glaucoma

Recruiting at 3 trial locations

Overseen By Ilesh Changela, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 6 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of a new eye drop solution, Bimatoprost Ophthalmic Solution 0.01%, for treating glaucoma and high eye pressure. Participants will be randomly assigned to use either the new solution or the standard treatment, LUMIGAN® (another form of Bimatoprost). The researchers aim to determine if the new solution is as effective as the standard one in lowering eye pressure. Individuals with chronic open-angle glaucoma or high eye pressure in both eyes, who are currently using or can switch their eye pressure medications, might be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

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

Research has shown that bimatoprost eye drops are generally safe for treating eye conditions like glaucoma. Previous studies found that bimatoprost 0.03% is well-tolerated, and long-term research supports its safety. Some individuals might notice mild side effects, such as changes in eye color, like darkening.

A real-world study found that a single bimatoprost implant safely lowered eye pressure for up to a year, which is important for managing glaucoma. These findings suggest that bimatoprost is effective and safe, making it a promising option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard care options for glaucoma, which often include various eye drops to reduce intraocular pressure, the Bimatoprost Ophthalmic Solution 0.01% is notable for its formulation. This version of bimatoprost is designed to maintain the effectiveness of reducing eye pressure while potentially minimizing side effects commonly associated with higher concentrations. Researchers are excited because this could mean better patient adherence to treatment due to fewer side effects, possibly leading to improved long-term outcomes for those with glaucoma.

What evidence suggests that Bimatoprost Ophthalmic Solution might be an effective treatment for glaucoma?

Research has shown that bimatoprost eye drops effectively lower eye pressure, crucial for treating glaucoma. Studies have found that it reduces eye pressure by about 5 to 8 units in patients with an average starting pressure of 24.5 units. This trial will compare two formulations: Bimatoprost Ophthalmic Solution, 0.01%, and LUMIGAN® (bimatoprost ophthalmic solution) 0.01%. A single bimatoprost implant maintained lower pressure for up to a year and reduced the need for other eye pressure medications. Using bimatoprost alone also led to significant pressure reductions, with many patients experiencing at least a 15% drop from their starting level. Overall, bimatoprost has consistently proven its ability to manage eye pressure effectively in glaucoma patients. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

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

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

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Bimatoprost Ophthalmic Solution

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.

How Is the Trial Designed?

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%

Bimatoprost Ophthalmic Solution is already approved in United States, European Union for the following indications:

Approved in United States as Lumigan for:

• Glaucoma - Open Angle
• Intraocular Hypertension
• Eyelash Hypotrichosis

Approved in European Union as Lumigan for:

• Glaucoma - Open Angle
• Intraocular Hypertension
• Eyelash Hypotrichosis

Approved in United States as Latisse for:

• Eyelash Hypotrichosis

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10804876/

Real-World Study of the Effectiveness and Safety ... A single bimatoprost implant administration safely and effectively reduced IOP for up to 1 year and decreased the need for topical IOP-lowering medications.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39946034/

Prospective 18-Month Study of Bimatoprost Intracameral ... Conclusions: The bimatoprost implant helped control IOP and decrease topical medication use. Throughout the 18 months after implant ...

3. durystahcp.com durystahcp.com/clinical-data

Clinical Data In clinical studies, DURYSTA® demonstrated an IOP reduction of approximately 5 to 8 mm Hg in patients with a mean baseline IOP of 24.5 mm Hg. Please see below ...

4. glaucomatoday.com glaucomatoday.com/articles/2003-jan/0103_02.html

Bimatoprost Monotherapy Lowers IOP More Effectively ... For latanoprost, 65% to 72% of patients achieved a 15% or greater reduction from their baseline IOP, and 50% to 62% experienced IOP lowering of 20% or more. The ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01099774?tab=results

Safety and Efficacy of Different Formulations of Bimatoprost ... Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension. ClinicalTrials.gov ID ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3116800/

Long-term safety evaluation of bimatoprost ophthalmic ... Bimatoprost 0.03% has a favorable safety and tolerability profile as characterized by six long-term studies.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01099774

Study Details | NCT01099774 | Safety and Efficacy of ... Safety and Efficacy of Different Formulations of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension. ClinicalTrials.gov ID ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772632025000273

Efficacy of bimatoprost sustained-release implant in ... In summary, the study's findings indicate that the bimatoprost implant effectively and safely treats open-angle glaucoma (OAG) by reducing intraocular pressure ...