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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04532710
Other study ID # TCS_19_02
Secondary ID 2019-002847-62
Status Completed
Phase Phase 2
First received
Last updated
Start date August 4, 2020
Est. completion date May 27, 2021

Study information

Verified date August 2022
Source Marinomed Biotech AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Drug:
Eye Drops, Solution in Single-Dose Container
Application of eye drops

Locations

Country Name City State
Austria Vienna Challenge Chamber Vienna

Sponsors (1)

Lead Sponsor Collaborator
Marinomed Biotech AG

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total Ocular Symptom Score The total ocular symptom score is the sum of four eye symptoms 'red eyes', 'itchy eyes', and 'watery eyes' and 'gritty feeling' scored every 15 minutes on a categorical scale from 0 (none) to 3 (severe) on challenge day at the times described in the Time and Events Schedule 0-4 hours of allergen challenge
Secondary Total nasal symptom score (TNSS) Total nasal symptom score (TNSS) is the sum of the symptoms "nasal congestion", "rhinorrhea"", "itchy nose" and "sneezing".
Each individual symptom of TNSS will be scored on a 4-point categorical scale from 0-3 (where "0"= none, "1"=mild, "2"=moderate, "3"=severe). TNSS will be assessed every 15 minutes during the four hours grass pollen allergen exposure challenge.
0-4 hours of allergen challenge
Secondary Total respiratory symptom score (TRSS) Total respiratory symptom score (TRSS) is the sum of the symptoms "cough", "wheeze", "dyspnea".
Each individual symptom of TRSS will be scored on a 4-point categorical scale from 0-3 (where "0"= none, "1"=mild, "2"=moderate, "3"=severe). TRSS will be assessed every 15 minutes during the four hours grass pollen allergen exposure challenge.
0-4 hours of allergen challenge
Secondary Nasal airflow (AAR) Nasal airflow (AAR) will be assessed every 60 minutes during the four hours grass pollen allergen exposure challenge 0-4 hours of allergen challenge
Secondary change in ocular redness image score change in ocular redness image score 0-4 hours of allergen challenge
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