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Prostaglandin Analog

Bimatoprost Ophthalmic Solution, 0.01% for Ocular Hypertension

Q: Is the enrollment for participants currently open in this clinical trial?

As per the information from clinicaltrials.gov, recruitment for this particular trial is currently closed. The posting of this study dates back to March 1st, 2024, with the latest update made on February 12th, 2024. Despite its closure for new participants, it's noteworthy that there are a substantial number of 905 ongoing trials seeking candidates actively at present.

Q: In how many different medical centers can patients access this clinical trial?

Enrollment is currently open at various centers including Clayton Eye Research in Morrow, Houston Eye Associates in Houston, and West Coast Eye Institute in Bakersfield, among four additional sites.

Q: What is the overall safety profile of Bimatoprost Ophthalmic Solution, 0.01% in individuals?

Our evaluation at Power indicates a safety rating of 1 for Bimatoprost Ophthalmic Solution, 0.01%. This is attributed to the Phase 1 nature of the trial, where there exists minimal data supporting both its safety and efficacy.

Phase 1

Waitlist Available

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

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

Study 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.Check my eligibility

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.See study design

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.

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Endpoint

Secondary outcome measures

Secondary Endpoint

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bimatoprost Ophthalmic Solution, 0.01%Experimental Treatment1 Intervention

Test Product: Bimatoprost Ophthalmic Solution, 0.01%

Group II: LUMIGAN® (bimatoprost ophthalmic solution) 0.01%Active Control1 Intervention

Reference Product: LUMIGAN® (bimatoprost ophthalmic solution) 0.01%

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

CBCC Global Inc.UNKNOWN

Amneal Pharmaceuticals, LLCLead Sponsor

11 Previous Clinical Trials

27,765 Total Patients Enrolled

1 Trials studying Ocular Hypertension

168 Patients Enrolled for Ocular Hypertension

Amneal EU, LimitedUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for participants currently open in this clinical trial?

"As per the information from clinicaltrials.gov, recruitment for this particular trial is currently closed. The posting of this study dates back to March 1st, 2024, with the latest update made on February 12th, 2024. Despite its closure for new participants, it's noteworthy that there are a substantial number of 905 ongoing trials seeking candidates actively at present."

Answered by AI

In how many different medical centers can patients access this clinical trial?

"Enrollment is currently open at various centers including Clayton Eye Research in Morrow, Houston Eye Associates in Houston, and West Coast Eye Institute in Bakersfield, among four additional sites."

Answered by AI

What is the overall safety profile of Bimatoprost Ophthalmic Solution, 0.01% in individuals?

"Our evaluation at Power indicates a safety rating of 1 for Bimatoprost Ophthalmic Solution, 0.01%. This is attributed to the Phase 1 nature of the trial, where there exists minimal data supporting both its safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes

2024. "A Randomized, Double-blind, Parallel-group, Two-arm, Multiple Dose, Multicenter, Bioequivalence Study With Clinical Endpoint in the Treatment of Subjects With Chronic Open-angle Glaucoma or Ocular Hypertension in Both Eyes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06267274.

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