Bimatoprost SR for Glaucoma

Recruiting at 126 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

Trial Summary

What is the purpose of this trial?

This trial tests a long-lasting eye medication called Bimatoprost SR. It is for people with certain eye conditions who can't use regular eye drops effectively. The medication works by helping fluid drain from the eye, reducing pressure. Bimatoprost has been widely used for glaucoma management, typically delivered via eye drops, but newer methods like sustained-release implants are being explored to improve efficiency.

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.

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

Research shows that Bimatoprost, when used as a 0.03% topical solution, effectively lowers eye pressure in patients with glaucoma by increasing fluid outflow from the eye. It has been found to be more effective than some other treatments and works well in combination with other glaucoma medications. ^{1 2 3 4 5}

Is Bimatoprost SR safe for humans?

Bimatoprost, in various formulations, has been studied for safety in patients with glaucoma and ocular hypertension. Some studies reported adverse reactions like changes in eye color and eyelid skin, but overall, it has been considered safe for use in these conditions. ^{1 6 7 8 9}

How is the drug Bimatoprost SR unique for treating glaucoma?

Bimatoprost SR is unique because it is a sustained-release implant that is injected directly into the eye, providing a long-term reduction in intraocular pressure (IOP) with fewer medications needed. This differs from traditional treatments like eye drops, which require daily application. ^{1 3 10 11 12}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

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

Efficacy and safety of bimatoprost in patients with uncontrolled glaucoma as alternative to filtration surgery. [2019]

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

Efficacy and safety of bimatoprost in patients with elevated intraocular pressure: a 30-day comparison with latanoprost. [2019]

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

Bimatoprost - a review. [2015]

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

Effects of treatment with bimatoprost 0.03% for 3 years in patients with normal-tension glaucoma. [2021]

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

Mechanism of action of bimatoprost (Lumigan). [2019]

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

Iris and periocular adverse reactions to bimatoprost in Japanese patients with glaucoma or ocular hypertension. [2021]

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

Twelve-month, randomized, controlled trial of bimatoprost 0.01%, 0.0125%, and 0.03% in patients with glaucoma or ocular hypertension. [2015]

9. China pubmed.ncbi.nlm.nih.gov

Efficacy and safety of bimatoprost in glaucoma and ocular hypertension in non-responder patients. [2020]

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

Short-Term Outcomes of Bimatoprost Sustained-Release Intracameral Implant in Glaucoma. [2023]

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

Phase 3, Randomized Study Comparing Intracameral Bimatoprost Implant 15 µg and Selective Laser Trabeculectomy in Patients with Open-Angle Glaucoma or Ocular Hypertension. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Bimatoprost-induced calcium signaling in human T-cells does not involve prostanoid FP or TP receptors. [2015]