Bimatoprost SR for Glaucoma

(TRITON Trial)

Recruiting at 151 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Allergan

Disqualifiers: Concurrent study, Previous Bimatoprost SR

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

Compensation: Varies

Number of Visits: Unknown

Duration: 48 months

515 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new sustained-release treatment called Bimatoprost SR to evaluate its effectiveness in lowering eye pressure in individuals with open-angle glaucoma (OAG) or ocular hypertension (OHT). The main goal is to determine how long Bimatoprost SR can maintain reduced eye pressure and assess its safety for patients. The trial includes two groups: one receives a higher dose, and the other receives a lower dose of Bimatoprost SR over different cycles. Individuals with OAG or OHT who are not well-controlled with current eye drops might be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to the development of a potentially groundbreaking treatment.

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

The trial protocol does not specify whether you need to stop your current medications. However, since the study is for those not adequately managed with current treatments, you might be able to continue them. It's best to discuss this with the trial coordinators.

Is there any evidence suggesting that Bimatoprost SR is likely to be safe for humans?

Research has shown that Bimatoprost SR is generally safe and effectively lowers eye pressure in individuals with open-angle glaucoma (OAG) and ocular hypertension (OHT). One study demonstrated good safety results for up to 24 months, indicating that the treatment reduced eye pressure without causing major issues.

Clinical trials tested both strengths of Bimatoprost SR, revealing positive safety outcomes. Only a few participants reported minor problems while using it.

Overall, evidence suggests that Bimatoprost SR is a safe option for managing high eye pressure in glaucoma and related conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Bimatoprost SR is unique because it offers a sustained-release formulation for treating glaucoma, a condition traditionally managed with daily eye drops like prostaglandin analogs. Unlike these standard treatments that require frequent application, Bimatoprost SR delivers medication directly into the eye over several months, potentially improving patient adherence and maintaining consistent intraocular pressure reduction. Researchers are excited about this approach as it may reduce the burden of daily drops and enhance long-term management of glaucoma.

What evidence suggests that Bimatoprost SR could be an effective treatment for glaucoma?

Research has shown that Bimatoprost SR effectively treats open-angle glaucoma (OAG). Studies have found that it lowers eye pressure, which is crucial for managing glaucoma. In this trial, participants will receive either Dose A or Dose B of Bimatoprost SR. The Bimatoprost SR implant successfully reduced eye pressure, even in patients with high, uncontrolled levels. It also reduced the need for other medications in cases where eye pressure was already under control. Overall, evidence supports its effectiveness and safety for individuals with OAG or high eye pressure. ^{1 3 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for people with open-angle glaucoma or ocular hypertension who need treatment to lower their eye pressure but can't use topical medication effectively. Participants should not have used Bimatoprost SR before or been in another drug/device study within the last 2 months.

Inclusion Criteria

I have glaucoma or high eye pressure needing treatment.

I have glaucoma or high eye pressure needing treatment.

Exclusion Criteria

Concurrent or anticipated enrollment in another investigational drug or device study or participation in such a study within 2 months prior to enrolling in this study.

I have received Bimatoprost SR treatment in my study eye before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1-3 cycles of Bimatoprost SR administrations for Dose B or 1-2 cycles for Dose A

48 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bimatoprost (SR)

Trial Overview The study tests how long the effect of Bimatoprost sustained release (SR) lasts in lowering intraocular pressure and its safety when given as needed to patients with open-angle glaucoma or ocular hypertension.

How Is the Trial Designed?

Group I: Bimatoprost SR - Dose B Experimental Treatment 1 Intervention

Study Eye: Participants received 1 - 3 Cycles of Bimatoprost SR administrations of Dose B Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.

Group II: Bimatoprost SR - Dose A Experimental Treatment 1 Intervention

Study Eye: Participants will receive 1 - 2 Cycles of Bimatoprost SR administrations of Dose A Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.

Who Is Running the Clinical Trial?

Allergan

Lead Sponsor

Trials

782

Recruited

277,000+

Brent Saunders

Allergan

Chief Executive Officer since 2015

JD and MBA from Temple University

Dr. David Nicholson

Allergan

Chief Medical Officer since 2015

MD from Harvard Medical School

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

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]

Citations

1. 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10972761/

Real-World Analysis of the Efficacy of Bimatoprost ... Bimatoprost SR glaucoma implant lowered IOP in eyes with high, uncontrolled baseline IOP, while it reduced the number of medications in eyes with a controlled ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02250651

NCT02250651 | Efficacy and Safety of Bimatoprost ... This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in patients with open-angle glaucoma or ocular hypertension.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11102741/

Bimatoprost SR for Glaucoma Therapy Implanted at the Slit ... This real-world analysis of bimatoprost SR use for glaucoma therapy complements Phase 3 study findings and demonstrates that the implant can ...

5. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=192024-092

Efficacy and Safety of Bimatoprost Sustained-Release (SR) ... This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in patients with open-angle glaucoma or ocular hypertension.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31884564/

24-Month Phase I/II Clinical Trial of Bimatoprost Sustained ... Bimatoprost SR showed favorable efficacy and safety profiles up to 24 months, with all evaluated dose strengths demonstrating overall IOP-reducing effects.

7. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=192024-091

Efficacy and Safety Study of Bimatoprost Sustained ... This study will evaluate the efficacy and safety of bimatoprost SR in participants with open-angle glaucoma or ocular hypertension.

8. eyewiki.org eyewiki.org/Sustained_Release_Glaucoma_Delivery_Systems

Sustained Release Glaucoma Delivery Systems Results from a study ... 24-month phase I/II clinical trial of bimatoprost sustained-release implant (bimatoprost SR) in glaucoma patients.