Ongoing Clinical Trials for Ocular Hypertension
There are currently 5 clinical trials testing new treatments for ocular hypertension across Europe. These studies are evaluating various eye drop formulations and an innovative implant designed to lower eye pressure and protect vision. Trials are taking place in Denmark, France, Germany, Greece, Italy, Poland, and Spain.
Clinical trial locations
- Denmark
- France
- Germany
- Greece
- Italy
- Poland
- Spain
Study Comparing Bimatoprost Eye Drops with Lumigan for Patients with Chronic Open-Angle Glaucoma or Ocular Hypertension
This trial, conducted in Italy, is comparing two formulations of bimatoprost eye drops for patients with chronic open-angle glaucoma or ocular hypertension. The study evaluates a new preservative-free version of bimatoprost (BIM-001) against the established product Lumigan.
Main inclusion criteria: Participants must be at least 18 years old with a confirmed diagnosis of chronic open-angle glaucoma or ocular hypertension in one or both eyes. At the start of the study, intraocular pressure (the pressure inside the eye) must be between 21 and 35 mmHg. Participants should have best corrected visual acuity equivalent to 20/200 or better in each eye, meaning they can see reasonably well with glasses or contact lenses. Patients must be able to stop their current eye pressure medications safely.
Main exclusion criteria: The study excludes patients with other eye diseases beyond the conditions being studied, those who have had eye surgery in the past three months, anyone currently using medications that might interfere with the study, individuals with known allergies to the study medications, pregnant or breastfeeding women, those who participated in another clinical trial within the last 30 days, and people with serious health conditions that could affect their ability to participate.
Study focus: The trial aims to determine which formulation is more effective at reducing eye pressure and how well patients tolerate each treatment. The study will run for 42 days, during which participants will visit the study centre multiple times to have their eye pressure monitored and to report any side effects or changes in their condition.
Investigational drugs: The study tests bimatoprost ophthalmic solution, an eye drop that lowers high pressure inside the eye by increasing the outflow of fluid. This belongs to a class of medications called prostaglandin analogs. Both the preservative-free formulation and Lumigan work in the same way but differ in their composition regarding preservatives.
Study Comparing Brimonidine and Timolol Eye Drops for Patients with Open-Angle Glaucoma or Ocular Hypertension
This Greek study is comparing a new generic formulation of brimonidine and timolol eye drops with the marketed product Combigan in patients with open-angle glaucoma or ocular hypertension.
Main inclusion criteria: Participants must be at least 18 years old and diagnosed with open-angle glaucoma or ocular hypertension in one or both eyes. The average eye pressure must be between 22 and 35 mmHg at baseline measurements taken at different times of the day. Participants should not have used any eye pressure-lowering medications for at least four weeks before the study. Best corrected visual acuity must be at least 20/100, and participants must have controlled blood pressure. Women of reproductive age who are sexually active must use effective birth control during the study.
Main exclusion criteria: The study excludes individuals with other eye diseases, those who have had eye surgery in the past three months, people allergic to the study medications or their ingredients, anyone using medications that might interfere with the treatment, pregnant or breastfeeding women, individuals with severe health conditions that might affect study results, those who participated in another clinical trial within the last 30 days, and people unable to follow study procedures or attend required visits.
Study focus: The trial runs for 12 weeks and monitors eye pressure at different times of the day to assess the effectiveness of both treatments. Regular follow-up visits at weeks 2, 6, and 12 will evaluate how well each formulation reduces eye pressure and check for any side effects.
Investigational drugs: The study tests brimonidine and timolol eye drops, a combination that works by decreasing fluid production in the eye and increasing fluid outflow, thereby lowering eye pressure. Brimonidine belongs to the alpha-2 adrenergic agonist class, while timolol is a beta-blocker.
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 the effects of two different latanoprost eye drop formulations on goblet cell density in patients with ocular hypertension or primary open-angle glaucoma. Goblet cells are important for keeping the eye moist and comfortable.
Main inclusion criteria: Participants must be at least 18 years old with intraocular pressure of at least 22 mmHg in each eye. They must have a diagnosis of either ocular hypertension or primary open-angle glaucoma and must be able to speak Danish.
Main exclusion criteria: The study excludes patients with any eye condition other than ocular hypertension or primary open-angle glaucoma, individuals not within the specified age range, and members of vulnerable populations who might need special protection or care.
Study focus: The trial compares BAK-preserved latanoprost eye drops (Xalatan) with preservative-free latanoprost (Monoprost) to understand how each affects goblet cell density, eye pressure, tear film composition, and the health of the eye’s surface. The study runs until December 31, 2026, with regular monitoring throughout.
Investigational drugs: Latanoprost is a well-established prostaglandin analog that reduces high eye pressure by increasing fluid outflow from the eye. The study specifically examines whether the presence of the preservative benzalkonium chloride affects eye health differently than the preservative-free formulation.
Study on Long-term Safety and Effectiveness of Bimatoprost SR for Patients with Open-angle Glaucoma or Ocular Hypertension
This multi-country study (Germany, France, Spain, and Poland) evaluates the long-term safety and effectiveness of Bimatoprost SR, an innovative implant that releases medication over time to lower eye pressure.
Main inclusion criteria: Participants must have completed one of the previous Bimatoprost SR Phase 3 studies or the open-label Phase 4 ARGOS study without ongoing safety concerns. They must provide written informed consent and authorization for the use of their health information. Women of childbearing potential must have a negative pregnancy test at the start. Patients must be able to understand and follow study instructions and attend all required visits.
Main exclusion criteria: The study excludes patients with other eye conditions that could affect results, those who have had eye surgery in the past three months, anyone using medications that might interfere with the study treatment, individuals allergic to the study medication or its ingredients, pregnant or breastfeeding women, those who participated in another clinical trial in the last 30 days, people with serious health conditions affecting their safety during the study, and anyone unable to follow study procedures or attend visits.
Study focus: The trial assesses how safe Bimatoprost SR is for long-term use and how effectively it maintains lower eye pressure over an extended period. Participants receive the implant through injection into the eye and attend regular follow-up visits for monitoring. Additional treatments may be given as needed based on individual response. The study is estimated to conclude by April 19, 2025.
Investigational drugs: Bimatoprost SR is a prostaglandin analog administered as an eye implant rather than traditional eye drops. It works by increasing the outflow of fluid from the eye, thereby reducing intraocular pressure and preventing damage to the optic nerve.
Study on the Effects of Bimatoprost SR and Timolol in Patients with Open-angle Glaucoma or Ocular Hypertension
This German study examines the effectiveness and safety of Bimatoprost SR implant in combination with timolol eye drops for patients with open-angle glaucoma or ocular hypertension.
Main inclusion criteria: Participants must have a diagnosis of open-angle glaucoma or ocular hypertension in both eyes, with both eyes requiring treatment to lower pressure. The doctor must believe that either eye can be effectively treated with beta-blocker eye drops (like timolol) or prostamides/prostaglandins (like LUMIGAN, Xalatan, Travatan) as single treatments. The angle between the iris and cornea must meet specific criteria confirmed by two eye doctors. At the first visit, the study eye must have intraocular pressure between 22 and 32 mmHg. The final count of endothelial cells (cells lining the inside of the cornea) must be confirmed as suitable by a Reading Center. Both men and women can participate.
Main exclusion criteria: The study excludes patients with other eye diseases beyond the conditions being studied, those not within the specified adult age range, members of vulnerable populations, individuals with medical conditions that might interfere with the study, people currently participating in another clinical trial, anyone who has had recent eye surgery or plans to have eye surgery during the study, those allergic to the study medication or its ingredients, and pregnant or breastfeeding women.
Study focus: The trial evaluates how well Bimatoprost SR can lower eye pressure and assesses its safety when used alone or in combination with timolol eye drops. Participants receive initial and repeated administrations of the implant as needed, with regular check-ups to monitor eye pressure and ensure patient safety.
Investigational drugs: Bimatoprost SR is a prostaglandin analog implant placed inside the eye to provide sustained release of medication. Timolol is a beta-blocker eye drop that reduces fluid production in the eye. Together, these medications work through different mechanisms to effectively lower intraocular pressure.
Summary
The five ongoing clinical trials for ocular hypertension reflect a diverse approach to managing this condition and related open-angle glaucoma. Most trials focus on improving existing treatments, with three studies examining different formulations of prostaglandin analogs (bimatoprost and latanoprost) and one testing a combination of brimonidine and timolol.
A notable trend is the emphasis on innovative delivery methods and formulation improvements. Several studies compare preservative-free versions with traditional formulations, reflecting growing concern about the long-term effects of preservatives on eye health. The Danish study specifically investigates this by measuring goblet cell density, which relates to eye comfort and moisture.
Two trials stand out by testing Bimatoprost SR, an implant that provides sustained medication release. This represents a significant departure from daily eye drops and could improve treatment adherence for patients who struggle with regular dosing schedules. These studies are being conducted in Germany and multiple European countries, indicating strong interest in this innovative approach.
Geographically, trials are distributed across seven European countries, with Germany hosting two studies. The multi-country Bimatoprost SR long-term safety study spans four nations, suggesting a coordinated European effort to evaluate this novel treatment approach. Most trials are single-country studies focusing on specific aspects of treatment, such as comparing generic formulations to branded products or examining the impact of preservatives on eye health.
