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Therapeutic Effect of Tacrosolv in Patients With Allergic Rhinoconjunctivitis

NCT04532710 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-08-25

No results posted yet for this study

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.

Conditions

  • Allergic Conjunctivitis
  • Allergic Rhinitis

Interventions

DRUG

Eye Drops, Solution in Single-Dose Container

Application of eye drops

Sponsors & Collaborators

  • Marinomed Biotech AG

    lead INDUSTRY

Principal Investigators

  • Eva Prieschl-Grassauer, PhD · CSO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04532710 on ClinicalTrials.gov