Bimatoprost for Open-Angle Glaucoma Treatment

Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% and LUMIGAN® in the Treatment of Chronic Open-Angle Glaucoma or Ocular Hypertension in Both Eyes.

Recruiting Phase 3 Interventional Study
Glaucoma, Open-Angle Ocular Hypertension
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
168 (estimated)
Sponsor
Amneal Pharmaceuticals, LLC · Industry
Who this trial is looking for

This trial is looking for adults with chronic open-angle glaucoma or ocular hypertension in both eyes. Participants will need to stop using certain eye medications before starting the trial.

Are You a Good Fit for This Trial?
Rules you out Significant ocular surface findingsSevere retinal diseaseUncontrolled systemic disease

You may be able to join if

  • I am at least 18 years old.
  • I have chronic open-angle glaucoma or ocular hypertension in both eyes.
  • I can stop using my current eye medications.
  • I have a body mass index (BMI) of at least 18.50.
  • I have a certain level of eye pressure (IOP) as decided by the doctor.
  • I can provide consent to join the trial.
  • I have good enough vision in both eyes.
  • I use an effective method of contraception if I can become pregnant.

You may not be able to join if

  • I am pregnant, breastfeeding, or planning to become pregnant.
  • I have a known allergy to Bimatoprost.
  • I have a serious eye disease in the last 2 months.
  • I have severe liver or kidney impairment.
  • I have had significant eye surgery in the last 6 months.
  • I have uncontrolled high eye pressure while using Bimatoprost before.
  • I have a serious health condition that affects my participation.
  • I have not taken any part in a clinical study in the last 90 days.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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About This Trial
This is a randomized, double-blind, two-treatment, single-period, parallel design, multiple dose at multiple clinical trial sites designed to demonstrate bioequivalence with clinical endpoint in subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. Test Product - Bimatoprost ophthalmic solution, 0.01% of Amneal EU, Limited Reference Product - LUMIGAN® (bimatoprost ophthal…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Subjects willing and able to provide voluntary informed consent and to follow protocol requirements. * Male or females aged ≥18 years. * Subjects having body mass index (BMI) ≥18.50 kg/m2. * Subjects with chronic open-angle glaucoma or ocular hypertension in both eyes. * Subje…
Contacts

Ilesh Changela, MBBS; MD

+91-79-67778300

ilesh@amnealindia.com

CONTACT