Ongoing Clinical Trials for Atopic Keratoconjunctivitis
This article provides information about 2 ongoing clinical trials investigating new treatments for atopic keratoconjunctivitis, a chronic inflammatory eye condition. These trials are testing different forms of cyclosporin eye drops in Denmark and Italy, aiming to reduce eye inflammation and improve symptoms such as itching, redness, and discomfort in adults living with this condition.
Clinical trial locations
- Denmark
- Italy
Study on Ciclosporin for Treating Atopic Keratoconjunctivitis in Adults
This trial is taking place in Denmark and focuses on testing an eye drop medication called Ikervis, which contains the active ingredient ciclosporin. The study aims to evaluate whether this treatment can effectively reduce eye inflammation and symptoms in adults with atopic keratoconjunctivitis over a four-month period.
Who can participate: To join this study, you must be at least 18 years old and have both atopic dermatitis and atopic keratoconjunctivitis. Your atopic dermatitis should be at least mild, measured by specific scoring systems from a dermatologist visit. Your eye condition must show signs of blocked glands in the upper eyelids, redness in the white part of the eye with a score of 2 or more, and some damage to the eye surface as measured by a fluorescein staining test. You must also be able to attend all scheduled appointments throughout the study.
Who cannot participate: The trial excludes people younger than 18 years old, those without a diagnosis of atopic keratoconjunctivitis, and individuals considered part of a vulnerable population who cannot provide proper consent or are in a dependent situation.
What the trial involves: Participants will use Ikervis eye drops four times daily for four months. The main focus is measuring changes in eye redness using the Bulbar Redness score from the beginning to the end of treatment. Regular follow-up appointments will monitor various aspects of eye health, including eye comfort, tear production, tear quality, and overall eye surface condition. Additional measurements will assess ocular discomfort, tear osmolarity (saltiness of tears), tear meniscus height, and meibomian gland function.
Investigational drug: Ikervis is an eye drop medication containing 1 mg/mL of ciclosporin. It works as an immunosuppressant, targeting the eye’s immune cells to reduce inflammation at the molecular level. While currently approved for treating severe dry eye disease, this trial is investigating whether it can also benefit people with atopic keratoconjunctivitis.
Study on the Safety and Effectiveness of Isocyclosporin A Eye Drops for Adults with Atopic Keratoconjunctivitis
This trial is being conducted in Italy and tests a medication called Isocyclosporin A in eye drop form. The study compares two different dosing schedules of this medication against a placebo to determine if it can effectively reduce eye itching and other symptoms in adults with atopic keratoconjunctivitis.
Who can participate: You must be 18 years or older with a confirmed diagnosis of atopic keratoconjunctivitis in both eyes. Your eye itching score must be 50 or more on a visual scale, and you must have at least one additional qualifying sign, such as eyelid reactions, a combined symptom score of 4 or more (including itching, tearing, discomfort, light sensitivity, and mucous discharge), eye surface damage with a score of 2 or more, or eye redness with a score of 1 or more. Your vision must be reasonably good in both eyes. If you are a woman of childbearing age, you must have a negative pregnancy test before starting. If you use skin treatments for allergies or atopic dermatitis, these must have been stable for at least 30 days before joining and should remain stable throughout the study.
Who cannot participate: The trial excludes anyone under 18 years old, those without a diagnosis of atopic keratoconjunctivitis, and people considered part of vulnerable populations who may need special protection.
What the trial involves: After a baseline assessment measuring your current symptoms, you will be randomly assigned to receive either Isocyclosporin A eye drops or a placebo. Depending on your group assignment, you will use the drops either twice daily or four times daily for four weeks. Throughout this treatment period, you will have weekly assessments to monitor changes in eye itching and other symptoms like tearing, discomfort, mucous discharge, and light sensitivity. The primary goal is to measure the change in your ocular itching score from the start to the end of treatment. After the four-week treatment period, there is a two-week follow-up period for continued observation.
Investigational drug: Isocyclosporin A is an eye drop solution currently in the investigational stage. It works by modulating the immune response, potentially reducing inflammation in the eye. Classified as an immunosuppressant, this medication is being studied specifically for its ability to alleviate ocular itching associated with atopic keratoconjunctivitis.
Summary
Currently, there are two ongoing clinical trials investigating treatments for atopic keratoconjunctivitis in Europe, one in Denmark and one in Italy. Both trials focus exclusively on adult patients and are testing different formulations of cyclosporin-based eye drops. The Danish trial evaluates ciclosporin (Ikervis) over a longer four-month treatment period with a primary focus on reducing eye redness, while the Italian trial tests Isocyclosporin A over a shorter four-week period with the main goal of reducing eye itching. Both studies aim to provide evidence for immunosuppressant eye drops as a treatment option for this chronic inflammatory eye condition. Interestingly, both trials require participants to have coexisting atopic dermatitis alongside their eye condition, reflecting the systemic allergic nature of this disease. These trials represent important research efforts to find effective treatments for a condition that can significantly impact quality of life and vision.
