Unpreserved Bimatoprost for Glaucoma

Recruiting at 66 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares a new eye drop, T4032, to an existing treatment, Lumigan® (Bimatoprost Ophthalmic), to determine its effectiveness for individuals with open-angle glaucoma or ocular hypertension (high eye pressure). The goal is to assess whether the new treatment matches the current standard. The trial includes two groups: one will use the new T4032 drops, and the other will use Lumigan®. Individuals diagnosed with open-angle glaucoma or ocular hypertension in both eyes may be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of a potentially new standard treatment.

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.

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

Research has shown that T4032, a new version of bimatoprost without preservatives, has undergone safety testing. In one study, participants used this treatment for about 82 days on average. The study found that T4032 was generally well-tolerated, with most participants experiencing no issues. Its safety profile was similar to Lumigan, another bimatoprost treatment already used for glaucoma.

No major safety issues emerged, suggesting that T4032 might be as safe as Lumigan. Since the trial is in a later phase, the treatment has already demonstrated some safety in earlier tests. This information may reassure those considering joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for glaucoma?

Researchers are excited about T4032 for glaucoma because it is an unpreserved formulation of bimatoprost, which could reduce irritation and allergies associated with preservatives found in standard options like Lumigan. Unlike most current glaucoma treatments that contain preservatives to maintain shelf life, T4032 aims to deliver the same pressure-lowering effects without the added chemicals that can cause discomfort. This could make it a more comfortable and accessible option for patients who are sensitive to preservatives in their eye drops.

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

Research has shown that T4032, a version of Bimatoprost without preservatives, works as effectively as Lumigan® 0.01% in lowering eye pressure, which is crucial for treating glaucoma. In this trial, participants will receive either T4032 or Lumigan® 0.01% to compare their effectiveness. Studies have found that both treatments effectively reduce eye pressure, a key factor in managing glaucoma and preventing vision loss. Additionally, T4032 may cause less eye redness than other forms of Bimatoprost, making it more comfortable for some patients. This suggests that T4032 could be a promising option for those seeking effective treatment for high eye pressure or glaucoma. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38506750/

Preservative-Free Bimatoprost 0.01% Ophthalmic Gel for ... PFB 0.01% ophthalmic gel has the same efficacy in lowering IOP as PB 0.01% and demonstrated less aggravation of conjunctival hyperemia at weeks 6 and 12.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05397600

NCT05397600 | Efficacy and Safety Assessment of T4032 ... The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy. Official Title. Efficacy and Safety ...

3. journals.lww.com journals.lww.com/glaucomajournal/fulltext/2024/06000/preservative_free_bimatoprost_0_01__ophthalmic_gel.7.aspx

Preservative-Free Bimatoprost 0.01% Ophthalmic Gel for... The primary efficacy outcome measure was the change in IOP from baseline to week 12 at 3 time points (8 am, 10 am, and 4 pm) in the worse eye (see definition in ...

4. isrctn.com isrctn.com/ISRCTN17779071

Efficacy and safety assessment of T4032 (unpreserved ... The main study purpose is to demonstrate that T4032 works as well as Lumigan® 0.01% in terms of treating patients with ocular hypertension or glaucoma.

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

Efficacy of bimatoprost sustained-release implant in ... Pooled analysis demonstrated that the bimatoprost SR implant significantly reduced IOP compared to placebo, with a mean difference of –1.53 mmHg. The implant ...

6. trial.medpath.com trial.medpath.com/clinical-trial/ae33ac87555df1e5/euctr2017-000846-23-sk-efficacy-safety-t4032-bimatoprost-lumigan-glaucoma

Efficacy and safety assessment of T4032 versus Lumigan® in ocular ... Efficacy and safety assessment of T4032 versus Lumigan® in ocular hypertensive or glaucomatous ... Outcome data and publication updates. Subscribe. Free • ...

7. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/rest/download/result/attachment/2017-000846-23/1/42605

SYNOPSIS LT4032-301 SAFETY RESULTS:​​ In the Safety set, the mean treatment exposure during the study was 81.8±11.6 days (range: 2 to 119 days) and was similar in the T4032 (81.8±11 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03825380?intr=AGN%20192024&aggFilters=studyType:int&viewType=Table&rank=6

Efficacy and Safety Assessment of T4032 Versus Lumigan ... The purpose of this study is to assess the efficacy and safety of T4032 versus Lumigan. Official Title. Efficacy and Safety Assessment of T4032 Versus Lumigan ® ...