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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.

Comparing two eye drops for glaucoma or high eye pressure treatment.

Recruiting
18 years and older
All
Phase 3

This study compares two eye drops, **Bimatoprost Ophthalmic Solution 0.01%** and **LUMIGAN®**, for treating a condition called **chronic open-angle glaucoma** or **ocular hypertension**. These conditions lead to increased pressure in the eyes, which can damage vision. Participants will be randomly assigned to use one of the drops every night at 10:00 pm for 42 days in both eyes. Researchers will check eye pressure after 2 weeks and 6 weeks to see how well each treatment works.

To be part of the study, you must be 18 or older, have specific eye conditions, and meet other health criteria. You should not have any severe eye diseases or be using certain medications. Pregnant or breastfeeding women, and those planning to become pregnant, cannot participate.

  • Duration: 42-day treatment period.
  • Visits: Clinical evaluations throughout the study.
  • Eligibility: Specific health and lifestyle criteria must be met.
Study details
    Glaucoma
    Open-Angle
    Ocular Hypertension

NCT05401357

Amneal Pharmaceuticals, LLC

13 December 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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