Clinical Trials for Open Angle Glaucoma
This article provides information about 8 ongoing clinical trials investigating new treatments for open angle glaucoma and ocular hypertension. These studies are testing various eye drops and implants designed to lower eye pressure and protect vision, conducted across multiple European countries including Italy, Spain, Germany, Poland, and several others.
Clinical trial locations
- Belgium
- Bulgaria
- Czechia
- Denmark
- France
- Germany
- Study on Long-term Safety and Effectiveness of Bimatoprost SR for Patients with Open-angle Glaucoma or Ocular Hypertension
- Study on the Effectiveness of Bimatoprost SR for Patients with Open-Angle Glaucoma or Ocular Hypertension
- Study on the Effects of Bimatoprost SR and Timolol in Patients with Open-angle Glaucoma or Ocular Hypertension
- Greece
- Hungary
- Ireland
- Italy
- Study Comparing Bimatoprost Eye Drops with Lumigan for Patients with Chronic Open-Angle Glaucoma or Ocular Hypertension
- Study on the Effectiveness of Bimatoprost SR for Patients with Open-Angle Glaucoma or Ocular Hypertension
- Study on the Effectiveness of Citicoline Eye Drops for Visual Field Preservation in Patients with Open Angle Glaucoma
- Poland
- Study on Long-term Safety and Effectiveness of Bimatoprost SR for Patients with Open-angle Glaucoma or Ocular Hypertension
- Study on the Effectiveness of Bimatoprost SR for Patients with Open-Angle Glaucoma or Ocular Hypertension
- Study on the Effectiveness of Citicoline Eye Drops for Visual Field Preservation in Patients with Open Angle Glaucoma
- Spain
- Sweden
Study Comparing Bimatoprost Eye Drops with Lumigan for Patients with Chronic Open-Angle Glaucoma or Ocular Hypertension
This Italian study compares two formulations of bimatoprost eye drops for patients with chronic open-angle glaucoma or ocular hypertension. The trial tests a preservative-free version called BIM-001 against the standard Lumigan drops.
Who can participate: Adults aged 18 or older with diagnosed chronic open-angle glaucoma or ocular hypertension may be eligible. Participants must have eye pressure between 21 and 35 mm Hg and vision correctable to at least 20/200. They should be able to switch from their current eye pressure medications and take a break from them.
Who cannot participate: Patients are excluded if they have other eye diseases beyond glaucoma or ocular hypertension, have had eye surgery in the past three months, are currently using medications that might interfere with the study, have known allergies to the study medications, are pregnant or breastfeeding, have participated in another clinical trial within the last 30 days, or have serious health conditions that might affect participation.
Study focus: The trial evaluates the effectiveness, safety, and tolerability of both treatments over 42 days. Researchers monitor eye pressure regularly and record any side effects or changes in eye health through multiple study visits.
Investigational drugs: Both treatments contain bimatoprost and work by increasing fluid drainage from the eye to lower pressure. The key difference is that BIM-001 is preservative-free, while Lumigan contains preservatives.
Study on the Effectiveness of Citicoline Eye Drops for Visual Field Preservation in Patients with Open Angle Glaucoma
This large multinational study, conducted across Spain, Belgium, France, Greece, Italy, Hungary, and Poland, investigates whether citicoline eye drops can help preserve the visual field in patients with glaucoma. The three-year trial compares citicoline drops to placebo drops.
Who can participate: Adults aged 18 or older with open-angle glaucoma, pseudoexfoliation glaucoma, or pigmentary glaucoma may join. Participants must have controlled eye pressure of 18 mmHg or less, vision correctable to at least 0.5, and visual field measurements not worse than -12 dB. Women of childbearing age must use effective birth control during the study and for 90 days after completion.
Who cannot participate: Patients without open-angle glaucoma, those whose condition is not worsening, patients not receiving best clinical practice treatment, those outside the specified age range, and members of vulnerable populations cannot participate.
Study focus: The trial assesses whether citicoline can slow down visual field deterioration over three years. Participants receive either 2% citicoline eye drops or placebo drops and attend regular check-ups to monitor vision and eye health using specialized tests including the Ocular Surface Disease Index and Optical Coherence Tomography.
Investigational drugs: Citicoline is a neuroprotective agent thought to support nerve cells in the eye. The trial tests whether these drops can protect the optic nerve from damage and preserve vision in patients with glaucoma.
Study Comparing Brimonidine and Timolol Eye Drops for Patients with Open-Angle Glaucoma or Ocular Hypertension
This Greek study compares a new generic combination of brimonidine and timolol eye drops with the marketed product Combigan. The 12-week trial evaluates whether the generic formulation is as effective as the branded version.
Who can participate: Adults aged 18 or older with open-angle glaucoma or ocular hypertension in one or both eyes may participate. Candidates must have average eye pressure between 22 and 35 mmHg measured at specific times, vision correctable to at least 20/100, and controlled blood pressure. Participants must not have used eye pressure-lowering drugs for at least four weeks before the study. Women of reproductive age who are sexually active must use effective birth control.
Who cannot participate: Exclusions include having other eye diseases, recent eye surgery within three months, allergies to study medications, current use of interfering medications, pregnancy or breastfeeding, severe health conditions, participation in another trial within 30 days, or inability to follow study procedures.
Study focus: The trial monitors changes in eye pressure at three times during the day (08:00, 12:00, and 16:00 hours) over 12 weeks. Follow-up visits occur at weeks 2, 6, and 12 to assess treatment effectiveness.
Investigational drugs: Both formulations combine brimonidine and timolol, which work together by decreasing fluid production within the eye and increasing fluid outflow, thereby lowering eye pressure.
Study on Glaucoma Treatment: Comparing Brimonidine, Pilocarpine Nitrate, and Brinzolamide in Patients with Newly Diagnosed Open-Angle Glaucoma
This Swedish study compares two treatment approaches for newly diagnosed patients: intensive combination therapy versus conventional step-wise treatment. The long-term trial continues until December 2027.
Who can participate: Adults between 40 and 78 years old with newly diagnosed open-angle glaucoma or PEX glaucoma may join. Participants must have a Visual Field Index of 65% or higher and should not have been previously treated with eye pressure-lowering medications.
Who cannot participate: Patients without confirmed glaucoma diagnosis, those without vision loss affecting the optic nerve, people outside the age range, and vulnerable populations are excluded.
Study focus: The trial compares how quickly the disease progresses under intensive combination treatment versus conventional single-medication therapy. Researchers monitor the rate of vision loss and also evaluate quality of life and treatment compliance.
Investigational drugs: The intensive group receives a combination of multiple eye drops including brimonidine, pilocarpine nitrate, brinzolamide, and potentially others such as timolol maleate, latanoprost, travoprost, betaxolol, bimatoprost, dorzolamide hydrochloride, and tafluprost. The conventional group starts with single-drop therapy and may add medications as needed. Some participants may also receive laser trabeculoplasty treatment.
Study on Goblet Cell Density in Patients with Ocular Hypertension or Primary Open Angle Glaucoma Using Benzalkonium Chloride and Latanoprost Eye Drops
This Danish study examines how different formulations of latanoprost affect goblet cells, which help keep the eye moist and healthy. The trial compares Xalatan, which contains preservatives, with preservative-free Monoprost.
Who can participate: Adults aged 18 or older who speak Danish may participate. Candidates must have eye pressure of at least 22 mmHg in each eye and a diagnosis of either ocular hypertension or primary open-angle glaucoma.
Who cannot participate: Patients with eye conditions other than ocular hypertension or primary open-angle glaucoma, those outside the specified age range, and members of vulnerable populations cannot join.
Study focus: The trial monitors changes in goblet cell density, eye pressure, corneal and conjunctival health, tear film composition, and dry eye symptoms. The study continues until December 2026.
Investigational drugs: Both formulations contain latanoprost, a prostaglandin analog that lowers eye pressure by increasing fluid outflow. The key difference is that Xalatan contains benzalkonium chloride as a preservative, while Monoprost is preservative-free.
Study on Long-term Safety and Effectiveness of Bimatoprost SR for Patients with Open-angle Glaucoma or Ocular Hypertension
This study, conducted in Germany, France, Spain, and Poland, evaluates the long-term safety and effectiveness of Bimatoprost SR, an eye implant that releases medication gradually over time. The trial is expected to conclude in April 2025.
Who can participate: Patients must have completed previous Bimatoprost SR Phase 3 studies or the ARGOS Phase 4 study without ongoing safety concerns. Participants must provide written informed consent, be able to follow study instructions, and attend all required visits. Females of childbearing age must have a negative pregnancy test at enrollment.
Who cannot participate: Exclusions include other eye conditions that could affect results, recent eye surgery within three months, use of interfering medications, allergies to study medications, pregnancy or breastfeeding, participation in another trial within 30 days, serious health conditions affecting safety, and inability to follow study procedures.
Study focus: The trial monitors long-term safety and the duration of pressure-lowering effects. Participants receive the implant and may receive additional treatments as needed based on individual response.
Investigational drugs: Bimatoprost SR is an implant placed inside the eye that releases bimatoprost, a prostaglandin analog, gradually over time. This approach aims to provide sustained eye pressure control without requiring daily eye drops.
Study on the Effectiveness of Bimatoprost SR for Patients with Open-Angle Glaucoma or Ocular Hypertension
This multinational study, conducted in Bulgaria, Italy, Germany, Poland, Ireland, Czechia, and Denmark, tests Bimatoprost SR for patients who have difficulty managing their condition with regular eye drops. The trial is expected to conclude in August 2025.
Who can participate: Adults aged 18 or older whose condition can be treated with standard eye drops may join. At baseline, participants must have stopped all eye pressure medications, have pressure between 22 and 34 mm Hg, acceptable corneal cell counts, and vision of 20/50 or better in the study eye. Participants must have difficulty managing their condition with regular drops due to side effects or adherence challenges. Both men and women can participate, and females must minimize pregnancy risk during the study.
Who cannot participate: Exclusions include other eye conditions affecting study results, recent eye surgery, use of interfering medications, severe allergic reactions to similar treatments, pregnancy or breastfeeding, medical conditions making the study unsafe, and inability to follow procedures or attend visits.
Study focus: The trial evaluates how long the implant’s pressure-lowering effect lasts in patients who struggle with regular eye drop regimens. Regular assessments include visual field tests, visual acuity measurements, and specialized eye examinations.
Investigational drugs: Bimatoprost SR is administered as an implant that provides sustained release of the active ingredient. By mimicking prostaglandins, it increases fluid outflow from the eye, thereby reducing pressure over an extended period.
Study on the Effects of Bimatoprost SR and Timolol in Patients with Open-angle Glaucoma or Ocular Hypertension
This German study evaluates Bimatoprost SR implant alone and in combination with Timolol eye drops. Some participants will receive the implant while others receive placebo, and some may also use Timolol drops.
Who can participate: Participants must have open-angle glaucoma or ocular hypertension in both eyes requiring treatment. The doctor must determine that both eyes can be effectively treated with beta-blocker drops or prostaglandin analog drops alone. The drainage angle must be suitable for implant placement, confirmed by two eye doctors. At the first visit, eye pressure must be between 22 and 32 mm Hg in the study eye, and between 19 and 32 mm Hg two hours later. Corneal cell counts must be acceptable.
Who cannot participate: Exclusions include other eye diseases beyond ocular hypertension or open-angle glaucoma, age outside the adult range, vulnerable population status, medical conditions interfering with the study, current participation in another trial, recent or planned eye surgery during the study, allergies to study medications, and pregnancy or breastfeeding.
Study focus: The trial monitors changes in eye pressure at specific times following initial and repeated administrations of the implant. Regular follow-up visits assess treatment effectiveness and safety.
Investigational drugs: Bimatoprost SR is an implant placed inside the eye, while Timolol is administered as eye drops applied directly to the eye. Together, they work to reduce eye pressure through complementary mechanisms.
Summary
These eight clinical trials reflect a diverse approach to managing open-angle glaucoma and ocular hypertension across Europe. A notable concentration of studies focuses on Bimatoprost SR, an innovative implant technology tested in multiple countries including Germany, France, Spain, Poland, Italy, Bulgaria, Ireland, Czechia, and Denmark. This emphasis on implant-based delivery systems represents a shift toward long-term treatment solutions that may help patients who struggle with daily eye drop regimens.
Traditional eye drop formulations remain under investigation, with studies comparing preservative-free versus preserved formulations and evaluating combination therapies. The citicoline study stands out as a large multinational effort across seven countries exploring potential neuroprotective approaches to preserve vision beyond simply lowering eye pressure.
Most trials focus on adults aged 18 and older, with one Swedish study specifically targeting newly diagnosed patients between 40 and 78 years old. The geographic distribution shows strong representation in Central and Southern Europe, with Germany hosting three trials and multiple studies spanning Italy, Poland, and Spain. Study durations vary considerably, from 42 days to three years, reflecting different research objectives from immediate efficacy to long-term safety evaluation.
