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Prostaglandin Analog

Bimatoprost Solutions for Glaucoma

Phase 1

Recruiting

Research Sponsored by Amneal Pharmaceuticals, LLC

Eligibility Criteria Checklist

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

Must have

Baseline (Day 0/hour 0) IOP ≥22 mm Hg and <28 mm Hg in each eye, with difference between the IOP in left and right eyes not being more than 5 mm Hg

Male or females aged ≥18 years

Must not have

Female who are pregnant, lactating or planning a pregnancy

Current or history of severe hepatic or renal impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 00.00 hour, 04.00 hours (4 hours ±1 hour after 00.00 hour), and 08.00 hours (8 hours ±1 hour after 00.00 hour) at day 14 (week 2) (± 4 days) and day 42 (week 6) (± 4 days) visits

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two different treatments to see if they are equivalent, using a method where neither the patients nor the researchers know which treatment is being given.

Who is the study for?

This trial is for people with chronic open-angle glaucoma or ocular hypertension in both eyes. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and not be on conflicting medications.

What is being tested?

The study is testing the effectiveness of a Bimatoprost Ophthalmic Solution against LUMIGAN®, which is an established treatment. Participants will be randomly assigned to one of two groups, receiving either the test solution or LUMIGAN® without knowing which one they're getting.

What are the potential side effects?

While specific side effects are not listed here, bimatoprost solutions like LUMIGAN® can cause eye redness, growth of eyelashes, itchy eyes, dryness, darkening of the iris and skin around the eyes.

Eligibility Criteria

Inclusion Criteria

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

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My initial eye pressure was between 22 and 28 mm Hg, with less than a 5 mm Hg difference between my eyes.

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I am 18 years old or older.

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I have chronic open-angle glaucoma or high eye pressure in both eyes.

Exclusion Criteria

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

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I am not pregnant, breastfeeding, or planning to become pregnant.

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I have or had severe liver or kidney problems.

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I have had a corneal transplant.

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My eye pressure was high and not controlled by bimatoprost alone.

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I have a severe eye disease.

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I do not have any uncontrolled illnesses.

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I have a history of HBV, HCV, or HIV.

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I have used an intraocular corticosteroid implant before.

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I have eye conditions that could affect pressure readings.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 00.00 hour, 04.00 hours (4 hours ±1 hour after 00.00 hour), and 08.00 hours (8 hours ±1 hour after 00.00 hour) at day 14 (week 2) (± 4 days) and day 42 (week 6) (± 4 days) visits

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~00.00 hour, 04.00 hours (4 hours ±1 hour after 00.00 hour), and 08.00 hours (8 hours ±1 hour after 00.00 hour) at day 14 (week 2) (± 4 days) and day 42 (week 6) (± 4 days) visits

This trial's timeline: 3 weeks for screening, Varies for treatment, and 00.00 hour, 04.00 hours (4 hours ±1 hour after 00.00 hour), and 08.00 hours (8 hours ±1 hour after 00.00 hour) at day 14 (week 2) (± 4 days) and day 42 (week 6) (± 4 days) visits for reporting.