drugset / Trial / NCT04532710

Therapeutic Effect of Tacrosolv in Patients With Allergic Rhinoconjunctivitis

NCT04532710 ↗

Phase 2 Completed 64 enrolled Marinomed Biotech AG
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2020-08-04
Primary completion
2021-05-27
Completion
2021-05-27

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tacrolimus Small molecule 50 ug/ml Topical