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

3 1 1

What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Multiprofile Hospital For Active Treatment Hadji Dimitar OOD Sliven Bulgaria
Universitaetsmedizin Goettingen Goettingen Germany

Other Sites

Site Name City Country Status
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Specialized Eye Diseases Hospital For Active Treatment-Varna EOOD Varna Bulgaria
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia Rome Italy
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Diakonie Klinikum Dietrich Bonhoeffer GmbH Neubrandenburg Germany
Hospital Santa Maria Della Misericordia Perugia Italy
Multiprofile Hospital For Active Treatment Dr. Bratan Shukerov AD Smolyan Bulgaria
Oftex s.r.o. Pardubice Czechia
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o. Olsztyn Poland
MBAL Trakia EOOD Stara Zagora Bulgaria
Specialized Eye Hospital For Active Treatment Pentagram ЕООD Sofia Bulgaria
Institute Of Eye Surgery Limited Waterford Ireland
Multispecialty hospital for active treatment Sveta Sofia EOOD Sofia Bulgaria
Asklepios Klinik Nord Heidberg Hamburg Germany
Royal Victoria Eye And Ear Hospital Dublin Ireland
Medical Center For Eye Health Focus EOOD Sofia Bulgaria
Uguwydaqzivboyicf Dwifn Sztfa Dv Rwkr Li Shrktkjt Terracina Italy
Msdwpak Ckqptq Vzgygb Ewnv Stara Zagora Bulgaria
Mfztkhw Chxivb Jqqkbjgg Lodz Poland
Oywilze Pzaboeptuuul Ceajihd Okmpmwkdde Sgy z ogzi Gdansk Poland
Rtlnhveibcpztn Glostrup Denmark
Uaxgiywvob Mhchi Gqrntkw Op Chxqcgbel Catanzaro Italy
Mejugow Cakrxi Odujol Oxs Burgas Bulgaria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
04.12.2019
Czechia Czechia
Not recruiting
04.12.2019
Denmark Denmark
Not recruiting
04.12.2019
Germany Germany
Not recruiting
04.12.2019
Ireland Ireland
Not recruiting
04.12.2019
Italy Italy
Not recruiting
04.12.2019
Poland Poland
Not recruiting
04.12.2019

Trial locations

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.

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 ID:
2022-502380-37-00
Protocol code:
1698-301-007
NCT ID:
NCT03850782
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on the Effectiveness of Citicoline Eye Drops for Visual Field Preservation in Patients with Open Angle Glaucoma

    Recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Greece Hungary Italy Poland +1
  • Study on Goblet Cell Density in Patients with Ocular Hypertension or Primary Open Angle Glaucoma Using Benzalkonium Chloride and Latanoprost Eye Drops

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark