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Study on the Effectiveness of Bimatoprost SR for Patients with Open-Angle Glaucoma or Ocular Hypertension

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment called Bimatoprost SR for individuals with Open-Angle Glaucoma or Ocular Hypertension. These are eye conditions that can lead to increased pressure inside the eye, potentially causing vision problems. The treatment involves using an implant that releases the medication over time to help lower the pressure in the eye.

The purpose of the study is to evaluate how long the pressure-lowering effect of Bimatoprost SR lasts in participants who have not been able to manage their eye pressure effectively with regular eye drops, possibly due to side effects or difficulty in using the drops consistently. Participants will receive the implant, and their eye health will be monitored over a period of time to assess the duration of the treatment's effectiveness.

Throughout the study, participants will undergo various eye examinations to ensure their safety and to gather information on how the treatment is working. These examinations may include checking the visual fields, measuring visual acuity, and performing detailed eye assessments using specialized equipment. The study aims to provide valuable insights into the potential benefits of Bimatoprost SR for managing eye pressure in individuals with these conditions.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant must be at least 18 years old and provide written informed consent.

    The participant's eye condition must be suitable for treatment with the Bimatoprost SR implant, as determined by the investigator.

  2. Step 2

    Baseline visit

    At the baseline visit, the participant must have stopped using all intraocular pressure (IOP) lowering medications.

    The participant's IOP should be between 22 and 34 mm Hg in the study eye.

    The participant's vision must meet specific criteria, with a visual acuity of 20/50 or better in the study eye.

  3. Step 3

    Implant administration

    The Bimatoprost SR implant is administered through intracameral use, which involves placing the implant inside the eye.

    The implant is designed to lower IOP in participants with open-angle glaucoma or ocular hypertension.

  4. Step 4

    Follow-up visits

    Participants will attend regular follow-up visits to monitor the duration of the IOP-lowering effect of the Bimatoprost SR implant.

    These visits will include assessments of visual fields, visual acuity, and other eye health parameters.

  5. Step 5

    Monitoring and assessments

    Throughout the study, participants will undergo various assessments, including slit-lamp biomicroscopic assessments and dilated ophthalmoscopic assessments.

    Additional tests may include contact ultrasound pachymetry, gonioscopy, and specular microscopy to evaluate eye health.

  6. Step 6

    Study completion

    The study is expected to conclude by August 28, 2025.

    Participants will have completed all required visits and procedures by this time.

Who can join the trial?

15 criteria

  • Participant must be at least 18 years old.
  • The study eye can be treated with certain eye drops as the only therapy, if used correctly.
  • The angle in the eye must be suitable for receiving a Bimatoprost SR implant, based on specific eye examinations.
  • Participant must have stopped using all eye pressure-lowering medications before the study starts.
  • At the start of the study, the eye pressure must be between 22 and 34 mm Hg.
  • The number of cells in the cornea, checked by a special microscope, must be acceptable.
  • At the start of the study, vision must be 20/50 or better in the study eye and 20/100 or better in the other eye.
  • Both males and females can participate.
  • Participant must provide written consent and agree to share personal health information.
  • Female participants must agree to minimize the risk of pregnancy during the study.
  • Female participants must not be pregnant or breastfeeding and must follow specific guidelines if they can become pregnant.
  • Participant must agree to stop their current eye pressure treatments as required by the study.
  • Participant must understand and be willing to follow study instructions and attend all required visits.
  • The eye pressure is not well managed with current medication for reasons other than the medication not working well.
  • Participant must have a diagnosis of either **Open-Angle Glaucoma** or **Ocular Hypertension** in the study eye, needing treatment to lower eye pressure.

Who cannot join the trial?

7 criteria

  • Participants who have other eye conditions that could affect the study results.
  • Individuals who have had eye surgery within a certain period before the study.
  • People who are using other medications that might interfere with the study treatment.
  • Participants with a history of severe allergic reactions to similar treatments.
  • Individuals who are pregnant or breastfeeding.
  • People with certain medical conditions that could make the study unsafe for them.
  • Participants who are unable to follow the study procedures or attend study visits.
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Investigated drugs

Bimatoprost SR is a medication used in this clinical trial to help lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. This medication is designed to be a long-lasting treatment option for those who have difficulty managing their condition with regular eye drops, either because they cannot tolerate them or have trouble sticking to their treatment schedule. Bimatoprost SR is administered in a way that allows it to gradually release the active ingredient over time, providing a sustained effect in reducing eye pressure.

What is already known about the treatment

Bimatoprost SR – This medication is administered as an implant directly into the eye, providing a sustained release of the drug. It is currently being studied in clinical trials, particularly in a Phase 3b study, to assess its effectiveness in treating open-angle glaucoma and ocular hypertension. The main therapeutic use of Bimatoprost SR is to lower intraocular pressure in patients who cannot manage their condition with standard eye drops due to intolerance or nonadherence. At the molecular level, Bimatoprost works by mimicking prostaglandins, which increase the outflow of fluid from the eye, thereby reducing pressure. It is classified pharmacologically as a prostaglandin analog.

Investigated diseases

  • Open-Angle Glaucoma

    This is a chronic eye condition where the drainage angle formed by the cornea and iris remains open, but the trabecular meshwork is partially blocked. This blockage leads to a gradual increase in eye pressure, which can damage the optic nerve. Over time, this damage can lead to vision loss, starting with peripheral vision. The progression is typically slow and painless, making it difficult to detect in early stages without regular eye exams. As the disease advances, central vision may also be affected.

  • Ocular Hypertension

    This condition is characterized by higher than normal pressure inside the eye, known as intraocular pressure (IOP). Unlike glaucoma, ocular hypertension does not cause any noticeable damage to the optic nerve or vision loss. However, it is considered a risk factor for developing glaucoma in the future. The condition progresses without symptoms, so regular monitoring by an eye care professional is essential. It is important to differentiate it from glaucoma, as the management and implications can differ.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502380-37-00Protocol code1698-301-007Estimated enrolment515 patientsSponsorAbbVie Deutschland GmbH & Co. KG

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).