Clinical Trials for Dry Eye Disease

This article provides detailed information about 11 ongoing clinical trials investigating new treatments for dry eye disease. These studies are evaluating innovative therapies including stem cell injections, plasma-rich growth factors, insulin eye drops, and medications targeting autoimmune-related dry eye. Trials are being conducted across multiple countries in Europe, offering opportunities for patients with various forms and severities of this condition.

Clinical trial locations

• Austria
  • Study on Long-Term Safety and Efficacy of Ianalumab for Patients with Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome
• Belgium
  • Study on Long-Term Safety and Efficacy of Ianalumab for Patients with Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome
• Bulgaria
  • Study on Long-Term Safety and Efficacy of Ianalumab for Patients with Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome
• Czechia
  • Study on Long-Term Safety and Efficacy of Ianalumab for Patients with Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome
  • Study on the Effects of Ianalumab in Adults with Rheumatoid Arthritis, Systemic Lupus Erythematosus, or Sjögren’s Disease
• France
  • Study on Long-Term Safety and Efficacy of Ianalumab for Patients with Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome
• Germany
  • Study on Long-Term Safety and Efficacy of Ianalumab for Patients with Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome
  • Study on the Effects of Ianalumab in Adults with Rheumatoid Arthritis, Systemic Lupus Erythematosus, or Sjögren’s Disease
• Greece
  • Study on Long-Term Safety and Efficacy of Ianalumab for Patients with Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome
• Hungary
  • Study on Long-Term Safety and Efficacy of Ianalumab for Patients with Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome
  • Study on the Effects of Ianalumab in Adults with Rheumatoid Arthritis, Systemic Lupus Erythematosus, or Sjögren’s Disease
• Italy
  • Study on Long-Term Safety and Efficacy of Ianalumab for Patients with Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome
  • Study on the Effects of Ianalumab in Adults with Rheumatoid Arthritis, Systemic Lupus Erythematosus, or Sjögren’s Disease
  • Study on the Safety and Effectiveness of Cenegermin Eye Drops for Patients with Dry Eye Disease
• Lithuania
  • Study on Long-Term Safety and Efficacy of Ianalumab for Patients with Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome
• Netherlands
  • Study on the Effects of Ianalumab in Adults with Rheumatoid Arthritis, Systemic Lupus Erythematosus, or Sjögren’s Disease
• Poland
  • Study on Long-Term Safety and Efficacy of Ianalumab for Patients with Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome
  • Study on the Effects of Ianalumab in Adults with Rheumatoid Arthritis, Systemic Lupus Erythematosus, or Sjögren’s Disease
• Portugal
  • Study on Long-Term Safety and Efficacy of Ianalumab for Patients with Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome
• Romania
  • Study on Long-Term Safety and Efficacy of Ianalumab for Patients with Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome
• Slovakia
  • Study on Long-Term Safety and Efficacy of Ianalumab for Patients with Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome
• Spain
  • Evaluation of Mesenchymal Stem Cell Eye Injections for Dry Eye Disease in Patients with Graft-versus-Host Disease Who Haven’t Responded to Standard Treatments
  • Study on Insulin Eye Drops for Treating Dry Eye in Patients Using Topical Hypotensors
  • Study on Long-Term Safety and Efficacy of Ianalumab for Patients with Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Hydrocortisone Sodium Phosphate for Patients with Dry Eye and Moderate Meibomian Gland Dysfunction
  • Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Insulin, Ciclosporin, and Benzalkonium Chloride in Patients with Moderate to Severe Dry Eye Disease
  • Study on the Effects of Ianalumab in Adults with Rheumatoid Arthritis, Systemic Lupus Erythematosus, or Sjögren’s Disease
  • Study on the Use of PRGF and Hypromellose Eye Drops for Treating Dry Eye Disease in Patients
  • Study on the Use of PRGF Eye Drops for Treating Dry Eye Disease in Patients
  • See more trials
• Sweden
  • Study on Long-Term Safety and Efficacy of Ianalumab for Patients with Sjögren’s Syndrome
  • Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome

Evaluation of Mesenchymal Stem Cell Eye Injections for Dry Eye Disease in Patients with Graft-versus-Host Disease Who Haven’t Responded to Standard Treatments

This trial is evaluating an innovative approach using mesenchymal stem cell injections for severe dry eye caused by Graft-versus-Host Disease. This condition can occur after bone marrow or stem cell transplants when the donated cells attack the recipient’s body, including the eyes.

Main inclusion criteria: Participants must be over 18 years old with severe chronic Graft-versus-Host Disease affecting both eyes for more than 3 months. The condition must be confirmed by specific eye surface damage measurements and severe symptoms scoring more than 33 points on the OSDI questionnaire. Patients must have already tried standard treatments like blood derivatives, insulin eye drops, or topical cyclosporine for at least three months without sufficient improvement.

Main exclusion criteria: The trial excludes pregnant or breastfeeding women, people with active eye infections, those who had eye surgery within the past 3 months, patients with severe corneal ulceration or uncontrolled glaucoma, active eye cancer, known allergies to the study medication, or those currently participating in another clinical trial.

Trial focus: The study tests two different doses of allogeneic mesenchymal stem cells injected under the eye’s membrane. Researchers will monitor improvements in eye surface integrity, tear production, eye redness, and oil-producing gland function. They will also collect tear and blood samples to analyze inflammation markers.

Investigational treatment: Mesenchymal stem cells are special cells that can help repair damaged tissues. In this trial, these cells come from donors and are injected into the eye to reduce inflammation and potentially restore normal tear film function.

Study on the Use of PRGF and Hypromellose Eye Drops for Treating Dry Eye Disease in Patients

This Spanish trial compares PRGF eye drops with standard artificial tears containing hypromellose. PRGF stands for Plasma Rich in Growth Factors, a treatment derived from blood components that may help healing and reduce inflammation.

Main inclusion criteria: Patients must be at least 18 years old with self-reported symptoms for at least 3 months. Clinical diagnosis requires a tear film break-up time of 10 seconds or less and eye surface damage greater than 1 on the Oxford scale. The OSDI symptom score must be 23 or higher.

Main exclusion criteria: People without a diagnosis of the condition, those outside the specified age range, vulnerable populations who cannot consent, patients unable to use the medication four times daily for 12 weeks, and those unwilling to follow study procedures are excluded.

Trial focus: The 12-week study has two parts. Part A evaluates the safety of PRGF eye drops, monitoring for adverse events and assessing tolerance. Part B compares the effectiveness of PRGF drops to artificial tears, measuring changes in symptoms and eye surface staining.

Investigational treatment: PRGF eye drops contain blood-derived growth factors that may promote healing, while the comparison treatment is standard artificial tears with 0.3% hypromellose for lubrication.

Study on the Use of PRGF Eye Drops for Treating Dry Eye Disease in Patients

This is another Spanish study evaluating PRGF eye drops, this time comparing them specifically to artificial tears containing 0.3% hypromellose over a 12-week period.

Main inclusion criteria: Similar to the previous trial, participants must be at least 18 years old with symptoms lasting at least 3 months. Clinical confirmation requires tear film break-up time of 10 seconds or less, eye surface staining greater than 1 on the Oxford scale, and OSDI score of 23 or higher.

Main exclusion criteria: Exclusions include patients without the diagnosis, those under 18 or over 65, vulnerable populations, people unwilling to use drops four times daily for 12 weeks, those currently using other treatments that cannot be stopped, patients with other interfering eye conditions, recent eye surgery within 6 months, pregnant or breastfeeding women, and those with known allergies to study components.

Trial focus: The study uses the same four-times-daily administration schedule for 12 weeks, with assessments at 2 weeks and 12 weeks. Researchers measure changes in symptoms using the OSDI questionnaire and the Oxford scale, along with visual acuity, tear quantity, and intraocular pressure.

Investigational treatment: PRGF eye drops are made from a patient’s own blood and contain healing substances, while the comparison treatment provides standard moisture relief through artificial tears.

Study on Insulin Eye Drops for Treating Dry Eye in Patients Using Topical Hypotensors

This Spanish trial explores whether insulin eye drops can help manage symptoms in patients who are already using topical hypotensors for conditions like ocular hypertension or glaucoma.

Main inclusion criteria: Participants must be at least 18 years old with written informed consent. They must have a diagnosis of the condition along with ocular hypertension or glaucoma controlled with hypotensive treatment.

Main exclusion criteria: The study excludes patients without the diagnosis, those not using topical hypotensors, people under 18, and vulnerable populations unable to give consent.

Trial focus: The six-month study compares insulin eye drops to a placebo (artificial tears), monitoring changes in corneal staining, conjunctival hyperemia, and tear film break-up time. Researchers also track side effects and adherence to existing hypotensive treatment.

Investigational treatment: Insulin, typically known for managing blood sugar, is being tested in eye drop form to potentially promote eye surface healing and increase tear production.

Study on Long-Term Safety and Efficacy of Ianalumab for Patients with Sjögren’s Syndrome

This large international trial spanning 16 European countries studies the long-term effects of ianalumab for Sjögren’s syndrome, an autoimmune disease that causes severe dry mouth and dry eyes when the immune system attacks moisture-producing glands.

Main inclusion criteria: Participants must have completed one of the previous NEPTUNUS core studies through Week 48 without discontinuation. The study doctor must believe continued treatment will provide benefit. Both men and women aged 18 or older can participate.

Main exclusion criteria: Exclusions include other serious health conditions that could interfere, pregnancy or breastfeeding, history of severe allergic reactions to medications, use of certain interfering medications, recent participation in another trial, history of substance abuse, infections requiring antibiotics, cancer history (except certain skin cancers), weakened immune system, and certain blood disorders.

Trial focus: The study assesses long-term safety and tolerability through Week 204, monitoring treatment-emergent adverse events and measuring changes in ESSDAI and ESSPRI scores that evaluate disease activity and symptoms. Regular blood samples measure medication concentrations and B-cell counts.

Investigational treatment: Ianalumab is administered subcutaneously and works by targeting specific parts of the immune system to reduce inflammation and other symptoms.

Study on the Effectiveness and Safety of Hydrocortisone Sodium Phosphate for Patients with Dry Eye and Moderate Meibomian Gland Dysfunction

This Spanish trial evaluates a combination treatment approach for patients with both dry eye and moderate Meibomian Gland Dysfunction, where oil-producing glands in the eyelids do not function properly.

Main inclusion criteria: Participants must be 18 years or older with documented diagnosis of both conditions. Specific measurements include TBUT of 5 seconds or less, OSDI score greater than 23, and MGD grade 2 to 3. Patients must be able to understand instructions and follow the medication regimen.

Main exclusion criteria: Exclusions include other interfering eye conditions, eye surgery within the last 6 months, current use of non-study eye treatments, known allergies to study treatments including hydrocortisone, history of increased intraocular pressure or glaucoma, pregnancy or breastfeeding, simultaneous participation in another trial, and serious health conditions affecting participation.

Trial focus: The treatment combines hydrocortisone sodium phosphate eye drops, lid hygiene practices, artificial tears, and a heated eye bag device called BlephaEyeBag. Researchers monitor changes over 14 days in symptoms, inflammatory tear proteins, and intraocular pressure, with follow-up visits at Days 28 and 84.

Investigational treatment: Hydrocortisone reduces inflammation, artificial tears provide lubrication, and the BlephaEyeBag provides warmth to improve meibomian gland function.

Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome

This trial across 11 European countries evaluates ianalumab for active Sjögren’s syndrome, comparing it to both placebo and standard glucocorticoid treatment.

Main inclusion criteria: Participants must be 18 years or older with Sjögren’s syndrome diagnosed according to 2016 criteria, with diagnosis duration of 7.5 years or less. They need positive anti-Ro/SSA antibody test or positive salivary gland biopsy, ESSDAI score of 5 or higher, and stimulated salivary flow rate of at least 0.05 mL/min. If on certain medications, doses must be stable for at least 30 days before starting.

Main exclusion criteria: Exclusions include other autoimmune diseases that might interfere, serious infections within 3 months, recent live vaccines, current treatment with another investigational drug, cancer history (except certain skin cancers), severe heart/liver/kidney problems, pregnancy or breastfeeding, recent substance abuse, major surgery within 4 weeks, and allergies to study medication.

Trial focus: The 52-week study uses subcutaneous injections, with participants randomly assigned to receive ianalumab, placebo, or glucocorticoids. The main focus is measuring changes in the ESSDAI score from the beginning to week 48.

Investigational treatment: Ianalumab is a monoclonal antibody that targets specific immune system parts to reduce symptoms.

Study on the Effectiveness and Safety of Ianalumab for Patients with Active Sjögren’s Syndrome

This trial, conducted across 9 European countries, tests ianalumab against placebo for active Sjögren’s syndrome over a 52-week period.

Main inclusion criteria: Similar to the previous trial, participants must be at least 18 years old with Sjögren’s syndrome diagnosed per 2016 criteria, diagnosed for 7.5 years or less. Requirements include positive anti-Ro/SSA antibody or salivary gland biopsy, ESSDAI score of 5 or higher, and salivary flow rate of at least 0.05 mL/min. Stable doses of certain medications for 30 days before starting are required.

Main exclusion criteria: Exclusions mirror the previous trial, including interfering autoimmune diseases, recent serious infections, recent live vaccines, current investigational drug treatment, cancer history, severe organ problems, pregnancy/breastfeeding, substance abuse history, recent major surgery, and medication allergies.

Trial focus: The double-blind study administers 150 mg per 1 mL doses via subcutaneous injection using pre-filled syringes. Regular assessments monitor ESSDAI score changes, salivary flow rate, systemic disease activity, and patient-reported outcomes through week 52, with final evaluation focusing on changes from beginning to end of treatment.

Investigational treatment: Ianalumab is a biologic drug (monoclonal antibody) designed to interact with the immune system at a molecular level.

Study on the Effectiveness and Safety of Insulin, Ciclosporin, and Benzalkonium Chloride in Patients with Moderate to Severe Dry Eye Disease

This Spanish trial examines whether insulin eye drops can improve moderate to severe cases when combined with other standard treatments like artificial tears and ciclosporin.

Main inclusion criteria: Patients must be older than 18 years with a diagnosis confirmed by eye staining equal to or greater than Oxford II level. They must have been treated with artificial tears or hyaluronic acid gels for at least 3 months and provide signed informed consent.

Main exclusion criteria: The study excludes patients without the condition, those younger than 18 or older than 65, and vulnerable populations unable to give consent themselves.

Trial focus: The six-month study compares insulin eye drops to placebo, measuring changes in corneal staining, symptoms, tear rupture time, and conjunctival hyperemia. Initial and final assessments track these parameters to evaluate effectiveness and safety.

Investigational treatment: Insulin eye drops are being explored for their potential to promote healing and reduce inflammation on the eye surface, potentially providing relief beyond standard moisture treatments.

Study on the Effects of Ianalumab in Adults with Rheumatoid Arthritis, Systemic Lupus Erythematosus, or Sjögren’s Disease

This trial across 7 European countries studies how the body processes ianalumab when administered in different forms for multiple autoimmune diseases, including Sjögren’s Disease which causes dry eyes.

Main inclusion criteria: Participants must be between 18 and 70 years old, weighing 35-150 kg with BMI between 18 and 35. They must have active Rheumatoid Arthritis, Sjögren’s Disease, or Systemic Lupus Erythematosus that might improve with B-cell reduction treatment. Allowed regular medications must be at stable doses for at least 4 weeks before starting.

Main exclusion criteria: The study excludes patients with these specific autoimmune conditions if other criteria are not met.

Trial focus: The study compares how 300 mg doses are absorbed when given via 2 mL auto-injector versus two 1 mL pre-filled syringes. Researchers monitor serum concentrations at specific intervals and track adverse events, laboratory tests, vital signs, and ECG parameters. An optional second phase tests a 2 mL pre-filled syringe versus two 1 mL syringes.

Investigational treatment: Ianalumab targets specific immune system proteins to reduce inflammation and immune response. The study also involves antiviral medications like emtricitabine, tenofovir disoproxil, tenofovir alafenamide, and entecavir, taken orally.

Additional trials are available beyond these ten detailed descriptions. These include a study in Italy on cenegermin eye drops containing Recombinant Human Nerve Growth Factor, which promotes nerve growth and repair to potentially improve tear production and eye surface health.

Summary

The 11 ongoing clinical trials for dry eye disease reflect a diverse research landscape exploring multiple therapeutic approaches. A notable concentration of trials is taking place in Spain, which hosts 10 of the 11 studies, indicating a strong research focus in this country. Other significant participation is seen across Central and Eastern European countries including Poland, Germany, Hungary, Czechia, Slovakia, Bulgaria, and Romania.

Several trials focus on Sjögren’s syndrome, an autoimmune condition that causes severe dry eye, with ianalumab being tested in multiple studies across various European countries. This medication represents a promising direction in treating autoimmune-related dry eye. Other innovative approaches being investigated include mesenchymal stem cell injections for graft-versus-host disease patients, PRGF eye drops derived from blood components, insulin eye drops for various patient populations, and hydrocortisone-based combination treatments for meibomian gland dysfunction.

The trials employ rigorous methodologies including placebo-controlled designs and various assessment tools to measure symptoms and eye surface health. Most studies require participants to be at least 18 years old and have documented diagnosis with specific severity criteria. Treatment durations range from several weeks to multiple years, depending on the study objectives. These trials collectively aim to expand treatment options for patients suffering from this chronic and often debilitating condition.