Therapeutic Effect of Tacrosolv in Patients With Allergic Rhinoconjunctivitis (NCT04532710) | Clinical Trial Compass
CompletedPhase 2
Therapeutic Effect of Tacrosolv in Patients With Allergic Rhinoconjunctivitis
Austria64 participantsStarted 2020-08-04
Plain-language summary
Allergic conjunctivitis is one of the most common comorbidities of allergic diseases, especially of allergic rhinitis.
Rhinoconjunctivitis is an allergic condition of the nasal mucosa and the eyes. Conjunctivitis is triggered by hypersensitivity to certain pollens and other airborne allergens and causes several symptoms such as reddened eyes, itchy eyes and can cause watery eyes and a scratchy feeling in the eye. Tacrolimus is a well-known immunosuppressiv active substance which is hardly soluble in water. Within Tacrosolv, Tacrolimus is completely dissolves in aqueous solution. The effectiveness of Tacrosolv will be tested for treatment of allergic conjunctivitis. Allergic subjects will be treated with aqueous formulation of tacrolimus 'Tacrosolv 50 micrograms per milliliter, eye drops' for 8 days. On day 1 and day 8 allergic patients will be challenged with grass pollen for a period of 4 hours and subjective allergic symptoms will be assessed.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
* Written informed consent obtained before any trial related procedures are performed
* Healthy male or female subjects aged 18 to 65 years
* Female subjects of child-bearing potential must have a negative pregnancy test and be willing to practice appropriate and safe contraceptive methods until the end of treatment visit
* A documented clinically relevant allergic history of moderate to severe SAR with rhinoconjunctivitis to grass pollen for the previous two years
* Subjects exhibit a moderate to severe response to approximately 1800 grass pollen grains/m3 within the first 2 hours in the Vienna Challenge Chamber, which is defined as total ocular symptom score (TOSS) of at least 4 (out of 12) with at least one single ocular symptom scored ≥2 ("moderate") at least twice during the first two hours of the screening challenge session using standard VCC grass pollen allergen mixture. Ocular symptom score is the sum of "ocular redness", "ocular itching", "watery eyes", "gritty feeling" each of which have been scored on a categorical scale from 0 to 3.
* Positive Skin Prick Test (SPT) response (wheal diameter at least 3 mm larger than diluent control) to grass pollen SPT solutions (standard Allergopharma) at screening or within the last 12 months prior to study start.
* Positive serum specific IgE against recombinant major allergen components of the used grass po…