Ongoing Clinical Trials for Glaucoma
There are currently 8 ongoing clinical trials exploring various treatments and management strategies for glaucoma, a group of eye conditions that damage the optic nerve and can lead to vision loss. These studies are testing different medications, surgical approaches, and regenerative therapies across several countries including Spain, Denmark, Finland, and Greece.
Clinical trial locations
- Denmark
- Finland
- Greece
- Spain
- Study Comparing Lidocaine Gel and Tetracaine/Oxybuprocaine Eye Drops for Anesthesia in Glaucoma Patients Undergoing Needling Procedures
- Study Comparing Lidocaine Gel and Tetracaine/Oxybuprocaine Eye Drops for Glaucoma Patients Undergoing Outpatient Needling Procedures
- Study on the Effectiveness of PRGF Eye Drops for Treating Dry Eye in Glaucoma Patients
- Study on the Effects of Fibrin Matrix on Eye Health in Glaucoma Patients Using Long-Term Eye Pressure Medications
Study on the Effectiveness of PRGF Eye Drops for Treating Dry Eye in Glaucoma Patients
This trial, conducted in Spain, focuses on patients who have both controlled glaucoma (or ocular hypertension) and moderate to severe dry eye syndrome. Many patients using eye pressure medications containing preservatives develop dry eye symptoms, which this study aims to address.
Inclusion criteria: Participants must be men or women over 50 years old with controlled glaucoma or ocular hypertension requiring medication with preservatives, and must have stopped using artificial tears at least one week before enrollment. They need a diagnosis of moderate to severe dry eye syndrome with an OSDI score of 13 or higher, and eye staining between grades 2 to 5 on the Oxford scale. Objective signs such as tear production measured by Schirmer’s test (3-9 mm/5 min) or tear break-up time of less than 10 seconds must also be present.
Exclusion criteria: Patients without both glaucoma and dry eye disease, those outside the specified age range, or those belonging to vulnerable populations cannot participate.
Focus and goal: The study evaluates whether PRGF (Plasma Rich in Growth Factors) eye drops can effectively relieve dry eye symptoms in patients with glaucoma. The trial will monitor changes in eye condition using various tests over 3 and 6 months, including the Oxford scale for staining, OSDI for symptoms, Schirmer test for tear production, and tear break-up time.
Investigational treatment: PRGF eye drops contain platelet concentrate derived from blood, believed to promote healing and reduce inflammation. These drops are used in the form of eye drops to treat dry eye disease specifically in patients who also have glaucoma.
Study on the Effects of Semaglutide for Patients with Glaucoma
Taking place in Denmark, this trial explores an innovative approach by testing semaglutide, a medication typically used for type 2 diabetes, for potential neuroprotective effects on the retina in patients with glaucoma.
Inclusion criteria: Participants must be 45 years or older, able to read and speak Danish, and have visual acuity of at least 0.5 in the study eye. They must have a diagnosis of primary open-angle glaucoma with specific visual field loss criteria (mean deviation of 16 dB or less) and nerve fiber layer defects identified by optical coherence tomography. They must also be receiving treatment to lower intraocular pressure.
Exclusion criteria: Individuals without a glaucoma diagnosis, those younger than 18 or older than 65, and members of vulnerable populations are excluded.
Focus and goal: The trial aims to determine whether oral semaglutide can safely improve the function of the inner retina in people with glaucoma. Researchers will assess changes in retinal function using electroretinogram tests at baseline, month 3, and month 6, along with contrast sensitivity tests and quality of life questionnaires.
Investigational treatment: Semaglutide is administered as oral tablets (Rybelsus) in strengths of 3 mg, 7 mg, and 14 mg. It works by mimicking a hormone called GLP-1, which may have protective effects on nerve cells in addition to its blood sugar regulation properties.
Study Comparing Laser Treatment and Tafluprost Eye Drops for Patients with Exfoliation Glaucoma or Ocular Hypertension
This Finnish trial compares two first-line treatment approaches for exfoliation glaucoma and ocular hypertension: a laser procedure versus traditional eye drops.
Inclusion criteria: Participants must be between 50 and 100 years old, able to participate for 12 months, and have exfoliation glaucoma or ocular hypertension with eye pressure less than 35 mmHg. The diagnosis must be newly established or recently identified.
Exclusion criteria: Patients with other eye conditions that might affect study results, previous eye surgery that could interfere, those using medications that might affect results, history of severe allergic reactions to study medications, pregnant or breastfeeding women, those unable to follow procedures, or participants in another trial within the last 30 days are excluded.
Focus and goal: The study aims to determine whether Selective Laser Trabeculoplasty (SLT) is as effective as eye drops when used as the first treatment option. Researchers will monitor the need for additional eye drops, eye dryness, changes in eye pressure, long-term success of SLT treatment, and whether further glaucoma surgery becomes necessary.
Investigational treatments: One group receives SLT, a laser procedure that improves fluid drainage from the eye to reduce pressure. The other group uses tafluprost eye drops (15 micrograms per milliliter), applied once daily in the evening to lower eye pressure.
Study Comparing Lidocaine Gel and Tetracaine/Oxybuprocaine Eye Drops for Anesthesia in Glaucoma Patients Undergoing Needling Procedures
Conducted in Spain, this trial compares different anesthetic approaches for patients undergoing needling procedures after glaucoma surgery, focusing on pain relief and patient satisfaction.
Inclusion criteria: Participants must be over 18 years old, have undergone glaucoma surgery requiring a needling procedure during consultation, and have signed informed consent understanding the study details.
Exclusion criteria: Patients without glaucoma, those younger than 18 or older than 65, and members of vulnerable populations cannot participate.
Focus and goal: The study evaluates which anesthetic method provides better pain relief and overall satisfaction during needling procedures. Researchers monitor pain levels using a numerical rating scale from 0 to 10, surgeon comfort, the need for additional anesthetic drops, and any complications during or after the procedure.
Investigational treatments: One group receives 2% lidocaine gel applied to the eye, while the other receives tetracaine/oxybuprocaine eye drops. Both are local anesthetics that block nerve signals to provide pain relief during ophthalmic procedures.
Study Comparing Lidocaine Gel and Tetracaine/Oxybuprocaine Eye Drops for Glaucoma Patients Undergoing Outpatient Needling Procedures
Also taking place in Spain, this trial is similar to the previous study but focuses specifically on outpatient settings and includes additional measurements of procedural efficiency.
Inclusion criteria: Participants must be over 18 years old, have undergone glaucoma surgery requiring a needling procedure, and have read, understood, and signed informed consent.
Exclusion criteria: Patients without glaucoma, those younger than 18 or older than 65, and those unable to make decisions for themselves are excluded.
Focus and goal: The study determines which anesthetic treatment is more effective in reducing pain during needling procedures. In addition to pain assessment, researchers measure the time taken to complete the procedure, the need for additional anesthesia or oral pain relief, and assess surgeon comfort and patient cooperation.
Investigational treatments: The same comparison is made between 2% lidocaine gel and tetracaine/oxybuprocaine eye drops, both serving as local anesthetics during the procedure.
Study on the Effects of Fibrin Matrix on Eye Health in Glaucoma Patients Using Long-Term Eye Pressure Medications
This Spanish trial explores regenerative therapy for the ocular surface in patients who have been using eye pressure medications for extended periods.
Inclusion criteria: Participants must be adults diagnosed with glaucoma who are currently receiving treatment with at least two preservative-free eye pressure-lowering medications, used at least three times daily, for at least the last two years. Both male and female participants are eligible.
Exclusion criteria: Patients with glaucoma or those belonging to vulnerable populations are not eligible for this particular study.
Focus and goal: The study evaluates how ENDORET-PRGF treatment affects the eye’s surface by measuring changes in tear osmolarity (the saltiness of tears). An increase in tear osmolarity can indicate problems with the eye’s surface. The treatment’s regenerative efficacy will be assessed by comparing tear osmolarity measurements before and after treatment.
Investigational treatment: ENDORET-PRGF is a solution for injection containing fibrin matrix. This substance is derived from the patient’s own blood and is rich in growth factors that help in healing and tissue regeneration. It is applied topically to the ocular surface.
Study Comparing Brinzolamide and Timolol Eye Drops for Patients with Glaucoma or Ocular Hypertension
Taking place in Greece, this trial compares a new generic combination eye drop to an existing branded product to determine if they are equally effective.
Inclusion criteria: Participants must be at least 18 years old, of any race, with either one or both eyes having open-angle glaucoma or ocular hypertension (either currently treated or untreated). They must be able to safely stop all eye pressure medications and undergo a washout period. Best-corrected visual acuity must be at least 20/100 in both eyes. Females must either be unable to become pregnant or use effective birth control if sexually active.
Exclusion criteria: Patients with any other eye disease besides ocular hypertension or glaucoma, those who had eye surgery in the last 3 months, those using interfering eye medications, those with severe allergies to study medications, pregnant or breastfeeding women, patients with uncontrolled medical conditions, and those unable to follow study procedures are excluded.
Focus and goal: The study determines if new generic brinzolamide and timolol eye drops are as effective and well-tolerated as the branded product Azarga in reducing eye pressure. The primary endpoint evaluates the difference in mean diurnal intraocular pressure change from baseline to week 12.
Investigational treatments: The generic combination contains brinzolamide 10mg/mL and timolol 5mg/mL as eye drops. Brinzolamide reduces fluid production within the eye, while timolol decreases fluid production and improves drainage. Azarga contains the same active ingredients for comparison.
Study on Diclofenac Sodium and Dexamethasone Phosphate for Patients with Uncontrolled Glaucoma After Surgery
This Danish trial examines post-surgical anti-inflammatory treatments to improve outcomes after trabeculectomy surgery.
Inclusion criteria: Participants must have primary open-angle glaucoma, pseudoexfoliation syndrome, pigment dispersion syndrome, or ocular hypertension. They must be older than 50 years, with postmenopausal women eligible. Patients must be scheduled for trabeculectomy surgery, with only one eye per participant included. They must provide informed consent and be able to follow study procedures.
Exclusion criteria: Patients with medically uncontrolled glaucoma that requires filtration surgery cannot participate.
Focus and goal: The study compares different anti-inflammatory treatments (diclofenac sodium, dexamethasone phosphate, or a combination) used after trabeculectomy to determine which helps control eye pressure better in the long term. The trial monitors eye pressure over 12 months using applanation tonometry and assesses changes in vision, optic nerve health, and surgical success over 24 months.
Investigational treatments: The study tests topical steroids (dexamethasone phosphate) and topical non-steroidal anti-inflammatory drugs (diclofenac sodium), administered as eye drops for up to 10 days following surgery. Some participants may receive a combination of both treatments.
Summary
The eight ongoing clinical trials for glaucoma reflect diverse approaches to managing this complex eye condition. Spain leads with four trials, demonstrating a strong research focus on both innovative regenerative therapies and procedural improvements. Denmark and Greece each contribute two and one trials respectively, while Finland adds one study to the mix.
Several notable themes emerge from these studies. Multiple trials focus on improving the comfort and outcomes of surgical procedures, particularly needling after glaucoma surgery, with two Spanish studies comparing different anesthetic approaches. Regenerative medicine features prominently, with PRGF (Plasma Rich in Growth Factors) being tested in two separate Spanish trials for treating dry eye disease and ocular surface problems in patients on long-term glaucoma medications.
The trials also explore novel therapeutic approaches, such as using semaglutide for its potential neuroprotective effects on the retina, and comparing first-line treatments (laser versus eye drops) for specific types of glaucoma. Post-surgical management receives attention through studies on anti-inflammatory treatments following trabeculectomy, while traditional medication comparisons continue with generic versus branded eye drop formulations.
These trials collectively address various aspects of glaucoma care, from initial treatment selection to managing treatment-related side effects and improving surgical outcomes. The diversity of approaches reflects the multifaceted challenges in glaucoma management and the ongoing search for better treatment options for patients.
