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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 treating glaucoma or high eye pressure.

Recruiting
18 years and older
All
Phase 3

This study is designed to compare two eye drops, **Bimatoprost ophthalmic solution** and **LUMIGAN®**, in treating people with **chronic open-angle glaucoma** or **ocular hypertension**. Glaucoma is a condition where the pressure inside the eye, called **intraocular pressure (IOP)**, is higher than normal, which can damage the eye. Ocular hypertension means the eye pressure is high but hasn't caused any damage. The study will test if both eye drops are equally effective (this is called **bioequivalence**).

Participants must be 18 or older and have glaucoma or high eye pressure in both eyes. They will use the eye drops once each evening for 42 days and have check-ups to see how their eyes are doing.

  • The study lasts for 42 days with regular check-ups.
  • Participants must stop using other eye medicines before starting the study.
  • Those who are pregnant or have allergies to the study drugs can't participate.

Before joining, participants will need to agree to follow study rules and provide informed consent, which means they understand the research and agree to be part of it.

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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