What is the mechanism of action of this treatment?

The most common treatments for Ocular Hypertension (OHT) aim to reduce intraocular pressure (IOP) by increasing the outflow of aqueous humor, the fluid in the eye. Prostaglandin analogs, such as Bimatoprost, work by enhancing the uveoscleral outflow, thereby lowering IOP. This is crucial for OHT patients as elevated IOP is a significant risk factor for the development of glaucoma, which can lead to irreversible vision loss. By effectively managing IOP, these treatments help to prevent the progression to glaucoma and preserve vision.

What side effects are associated with this type of intervention?

Common treatments for ocular hypertension that increase aqueous humor outflow, such as prostaglandin analogs (e.g., Bimatoprost, Latanoprost, Travoprost), often cause side effects like conjunctival hyperemia (eye redness), eyelash growth, and changes in iris pigmentation. Less frequently, they may lead to macular edema and uveitis. Local side effects can include eye irritation, dryness, and discomfort.

What prior FDA approvals exist?

FDA-approved treatments for ocular hypertension that increase aqueous humor outflow include prostaglandin analogs such as latanoprost, travoprost, and tafluprost. These medications, like Bimatoprost, work by enhancing the outflow of aqueous humor through the uveoscleral pathway, thereby reducing intraocular pressure. Bimatoprost itself is also FDA-approved in its topical form for this purpose. These treatments are commonly used due to their efficacy and once-daily dosing convenience.

What other types of research exist?

Promising novel alternatives to Bimatoprost sustained release for ocular hypertension patients include: 1) Netarsudil, a Rho kinase inhibitor that increases aqueous humor outflow, 2) Latanoprostene bunod, a nitric oxide-donating prostaglandin analog that enhances outflow through both the trabecular meshwork and uveoscleral pathways, and 3) Minimally invasive glaucoma surgeries (MIGS) such as the iStent inject and Hydrus Microstent, which improve aqueous outflow with a favorable safety profile.

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Prostaglandin Analog

Bimatoprost SR for Glaucoma

Phase 3

Waitlist Available

Research Sponsored by Allergan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Diagnosis of either Diagnosis of either open angle glaucoma (OAG) (i.e., primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or ocular hypertension requiring intraocular pressure-lowering treatment.

Diagnosis of either open angle glaucoma (OAG) (i.e., primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or ocular hypertension requiring intraocular pressure-lowering treatment.

Must not have

Previous administration with Bimatoprost SR in the study eye.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of Bimatoprost SR include red eyes, eye irritation, skin darkening around the eyes, eyelash growth, and potential changes in eye color. These are based on known effects of similar treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have glaucoma or high eye pressure needing treatment.

Select...

I have glaucoma or high eye pressure needing treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients experiencing a treatment emergent adverse event

Retreatment or rescue administered for IOP

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Bimatoprost SR - Dose BExperimental Treatment1 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 AExperimental Treatment1 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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Ocular Hypertension (OHT) aim to reduce intraocular pressure (IOP) by increasing the outflow of aqueous humor, the fluid in the eye. Prostaglandin analogs, such as Bimatoprost, work by enhancing the uveoscleral outflow, thereby lowering IOP. This is crucial for OHT patients as elevated IOP is a significant risk factor for the development of glaucoma, which can lead to irreversible vision loss. By effectively managing IOP, these treatments help to prevent the progression to glaucoma and preserve vision.

Prostaglandin mediated inflammatory changes induced by alpha-adrenoceptor stimulation in the sympathectomised rabbit eye.