Ongoing Clinical Trials for Conjunctivitis
This article provides information about 3 ongoing clinical trials investigating treatments for conjunctivitis, specifically allergic rhinoconjunctivitis caused by common allergens such as dust mites, grass pollen, and birch pollen. These studies are examining immunotherapy approaches delivered through injections or sublingual sprays in Germany and Spain.
Clinical trial locations
- Germany
- Spain
Study on the Safety and Effectiveness of Subcutaneous Immunotherapy with Der p 1, Der p 2, and Der p 23 Allergens for Patients with Allergic Rhinitis or Rhinoconjunctivitis
This trial is investigating a treatment for people experiencing symptoms like sneezing, runny nose, and itchy eyes caused by allergies to dust mites. The study focuses on those with allergic rhinitis or rhinoconjunctivitis, and some participants may also have allergic asthma that is well-controlled.
Main inclusion criteria: Participants must be between 12 and 65 years old and have moderate or severe persistent symptoms for at least one year. They need to show a positive skin prick test, with a reaction at least 3 mm larger than the negative control, and have specific IgE levels of at least 0.7 kU/L. For those with asthma, lung function measured by FEV1 must be at least 80%. Women of childbearing age must use effective contraception and have a negative pregnancy test.
Main exclusion criteria: People with uncontrolled asthma, history of severe allergic reactions to study medications, serious health conditions that might interfere with the study, current participation in another trial, pregnancy or breastfeeding, history of drug or alcohol abuse, or recent allergy immunotherapy within the last 12 months cannot participate.
Focus and goals: The study evaluates the safety and effectiveness of subcutaneous immunotherapy, which involves injecting allergens under the skin to help the body build tolerance over time. Participants will receive 12 maintenance doses at different concentrations to determine the optimal dose that provides the best balance of benefits and risks. Regular monitoring will track symptom changes, medication use, and quality of life improvements.
Investigational drugs: The treatment uses three purified allergens from dust mites: Der p 1, Der p 2, and Der p 23. These allergens work by exposing the body to small amounts of dust mite proteins, training the immune system to react less severely and potentially reducing allergic symptoms over time.
Study on the Effectiveness and Safety of Phleum Pratense Pollen Extract for Patients with Moderate-to-Severe Grass Pollen Allergy
This trial examines a treatment for individuals who have suffered from moderate-to-severe allergic symptoms due to grass pollen for at least two years. The condition affects the nose and eyes, causing symptoms during the grass pollen season.
Main inclusion criteria: Participants must be between 18 and 65 years old and have experienced moderate-to-severe allergic rhinitis or rhinoconjunctivitis due to grass pollen for at least two years. They may have mild-to-moderate, well-controlled asthma or no asthma at all. For those with asthma, FEV1 must be more than 70% of predicted normal. A positive skin prick test with a wheal of at least 3 mm, specific IgE antibodies to Phleum pratense, a symptom score of 2 or more from previous seasons, and a positive nasal provocation test are required.
Main exclusion criteria: People without at least two years of moderate-to-severe symptoms, those outside the specified age range, unwillingness to follow study procedures, interfering medical conditions, medications that could affect results, pregnancy or breastfeeding, recent participation in another trial, history of severe reactions to similar treatments, or history of drug or alcohol abuse cannot participate.
Focus and goals: The study aims to find the most effective and well-tolerated dose of SULGEN® Spray Phleum pratense, balancing benefits and risks. The treatment is compared with a placebo during the peak grass pollen period to assess effects on symptoms, medication needs, and quality of life. Participants will use an electronic diary to track symptoms and medication use throughout the trial.
Investigational drugs: SULGEN® Spray Phleum pratense is a sublingual immunotherapy treatment administered as a spray under the tongue. It contains extracts from Timothy grass and aims to help the immune system become less sensitive to grass pollen, reducing symptoms and the need for other medications.
Study on the Effectiveness and Safety of Sublingual Immunotherapy with Betula Pendula Pollen Extract for Patients with Birch Pollen Allergy
This trial studies a treatment for people who have suffered from allergic symptoms caused by birch pollen for at least two years. Symptoms include sneezing, runny or blocked nose, and itchy or watery eyes during birch pollen season.
Main inclusion criteria: Participants must be between 18 and 65 years old with moderate-to-severe allergic rhinitis or rhinoconjunctivitis due to birch pollen for at least two years. They must have well-controlled mild-to-moderate asthma or no asthma. For those with asthma, FEV1 must be more than 70% of predicted normal. Participants need a positive skin prick test with a wheal of at least 3 mm, specific IgE to birch pollen of 0.7 kU/L or higher, a retrospective symptom score of 2 or higher from previous seasons, and a positive nasal provocation test.
Main exclusion criteria: People without at least two years of moderate-to-severe symptoms caused by birch pollen, those outside the specified age range, and vulnerable populations who cannot give proper consent cannot participate.
Focus and goals: The study seeks to identify the most effective and well-tolerated dose of SULGEN® Spray Betula verrucosa. Participants will receive either the active spray or a placebo, and the study will compare effects on symptoms and quality of life during the peak birch pollen season. An electronic diary will track symptoms and medication use to help researchers understand the treatment’s impact on daily life.
Investigational drugs: SULGEN® Spray Betula verrucosa is a sublingual immunotherapy treatment applied under the tongue. It contains birch pollen extracts and works by gradually helping the body become less sensitive to birch pollen, with the aim of reducing allergy symptoms over time.
Summary
These three clinical trials represent ongoing efforts to develop effective immunotherapy treatments for allergic rhinoconjunctivitis caused by different allergens. Two trials are being conducted in Germany, focusing on grass and birch pollen allergies, while one trial in Spain examines dust mite allergies. All three studies use immunotherapy approaches, either through subcutaneous injections or sublingual sprays, aiming to train the immune system to tolerate allergens better.
A notable observation is the focus on dose-finding studies, seeking to identify optimal treatment levels that balance effectiveness with safety. The German trials both use sublingual spray formulations under the SULGEN® brand, while the Spanish trial employs traditional subcutaneous injections. All studies require participants to have at least two years of documented allergic symptoms and use rigorous testing including skin prick tests, specific IgE measurements, and nasal provocation tests to confirm eligibility.
These trials are expected to provide valuable information about managing seasonal and year-round allergic conditions affecting both the nose and eyes, potentially offering new treatment options for patients who suffer from these chronic conditions.
