Unpreserved Bimatoprost for Glaucoma

Recruiting at 63 trial locations

Overseen By Corentin LECAMUS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Laboratoires Thea

Disqualifiers: Trauma, Infection, Inflammation, 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

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

684 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called T4032. It aims to see if T4032 is as effective as Lumigan® 0.01% for patients with glaucoma or high eye pressure. The study will compare how well each treatment reduces eye pressure.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications.

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

Research shows that Bimatoprost effectively lowers eye pressure in people with glaucoma or high eye pressure. It has been found to work better than some other treatments, like timolol and latanoprost, in reducing eye pressure and maintaining it over time. ^{1 2 3 4 5}

Is unpreserved bimatoprost safe for humans?

Research on bimatoprost, including its use in eye drops and implants, shows it is generally safe for humans. Studies have evaluated its safety in different forms and concentrations, such as 0.01% and 0.03% solutions, and as a sustained-release implant, with no major safety concerns reported. ^{1 2 4 5 6}

What makes the drug Bimatoprost unique for treating glaucoma?

Bimatoprost is unique because it is a synthetic prostamide analog that effectively lowers intraocular pressure (IOP) by increasing fluid outflow in the eye, and it has been shown to be more effective than some other treatments like timolol. Additionally, it can be administered as a sustained-release implant, reducing the need for daily eye drops. ^{4 5 7 8 9}

Eligibility Criteria

This trial is for individuals with open-angle glaucoma or ocular hypertension in both eyes who have signed an informed consent. It's not suitable for those with recent eye trauma, infection, significant inflammation, known allergies to the medication components, or if they are pregnant or breastfeeding.

Inclusion Criteria

Informed consent dated and signed

Informed consent dated and signed.

Both of my eyes have been diagnosed with open-angle glaucoma or high eye pressure.

Exclusion Criteria

Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s)

Pregnancy or breast-feeding

I have not had any serious injuries, infections, or inflammation in the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either T4032 or Lumigan® 0.01% to assess efficacy and safety

12 weeks

Visits at baseline, Week 2, Week 6, and Week 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bimatoprost Ophthalmic

Trial Overview The study aims to show that T4032 (a preservative-free version of Bimatoprost 0.01%) is just as effective as Lumigan® 0.01% in treating patients with ocular hypertension or glaucoma.

Participant Groups

Group I: T4032 Experimental Treatment 1 Intervention

Group II: Lumigan Active Control 1 Intervention

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

Approved in United States as Lumigan for:

• Open-angle glaucoma
• Ocular hypertension
• Eyelash hypotrichosis

Approved in European Union as Lumigan for:

• Open-angle glaucoma
• Ocular hypertension

Approved in United States as Latisse for:

• Eyelash hypotrichosis

Who Is Running the Clinical Trial?

Laboratoires Thea

Lead Sponsor

Trials

64

Recruited

6,900+

Findings from Research

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]

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 effectively lowers intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension, showing approximately 1-2 mmHg greater IOP reduction compared to latanoprost and superior efficacy over timolol in clinical trials.

Long-term use of bimatoprost maintains its effectiveness without significant safety concerns, with common side effects being mild conjunctival hyperaemia and eyelash growth, making it a valuable treatment option for glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on bimatoprost in glaucoma therapy. Cantor, LB.[2019]

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]

In a study of 122 eyes from 84 patients, bimatoprost sustained-release (SR) significantly reduced intraocular pressure (IOP) from 18.5 mmHg to 16.0 mmHg and decreased the number of required glaucoma medications from 2.1 to 1.2, indicating its efficacy in managing glaucoma.

Among 41 eyes from 31 patients with prior glaucoma surgeries, bimatoprost SR also reduced medication burden, showing a decrease from 1.9 to 1.0 medications, suggesting it is effective even for patients who have undergone previous surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of bimatoprost sustained-release intracameral implant on intraocular pressure and medication burden in patients with prior glaucoma surgery. Bowers, ME., Wong, MK., Ventimiglia, J., et al.[2023]

Bimatoprost effectively lowers intraocular pressure (IOP) by 7-8 mmHg over 24 hours when used as a 0.03% topical preparation once daily, making it more effective than timolol and comparable to other prostaglandin analogs.

While bimatoprost is generally safe, with mild side effects like conjunctival hyperemia and periorbital pigmentation, it is also cost-effective for treating open-angle glaucoma, especially when used in combination with other medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bimatoprost - a review. Patil, AJ., Vajaranant, TS., Edward, DP.[2015]

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

Bimatoprost Implant: First Approval. [2020]

2. 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]

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

An update on bimatoprost in glaucoma therapy. [2019]

4. 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]

5. France pubmed.ncbi.nlm.nih.gov

Effect of bimatoprost sustained-release intracameral implant on intraocular pressure and medication burden in patients with prior glaucoma surgery. [2023]

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

Bimatoprost 0.01% vs bimatoprost 0.03%: a 12-month prospective trial of clinical and in vivo confocal microscopy in glaucoma patients. [2021]

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

Bimatoprost - a review. [2015]

8. England pubmed.ncbi.nlm.nih.gov

Clinical pharmacology of bimatoprost. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Bimatoprost: a member of a new class of agents, the prostamides, for glaucoma management. [2019]