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NCT03830359 Clinical Trial

Efficacy, Safety of T2769 in Dry Eye Disease

Dry Eye Syndrome Clinical Trial

Official title:
Efficacy and Safety Assessment of T2769 in Patients With Moderate to Severe Dry Eye Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03830359
Other study ID # LT2769-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date February 18, 2019

Study information
Verified date August 2019
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Efficacy of T2769 in Dry Eye Desease

Description:

Multicenter and open study

Recruitment information / eligibility
Status Completed
Enrollment 62
Est. completion date February 18, 2019
Est. primary completion date February 18, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Signed and dated informed consent - Male or female aged from = 18 years old - Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study screening Exclusion Criteria: - Best far corrected visual acuity = 2/10 - Severe blepharitis Severe dry eye

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• T2769
At least 55 enrolled patients for at least 50 evaluable patients treated by T2769 for 42 days

Locations
Country Name City State
Tunisia Hôpital Universitaire Tahar Sfar Mahdia
Tunisia "Hôpital Universitaire Fattouma Bourguiba Monastir
Tunisia "Hôpital de Forces de Sécurité Intérieure La Marsa Tunis

Sponsors (1)
Lead Sponsor Collaborator
Laboratoires Thea

Country where clinical trial is conducted

Tunisia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ocular Symptomatology Change from baseline in ocular symptomatology on a Visual Analog Scale (0=No discomfort and 100=Maximal discomfort) at Day 42. Baseline and Day 42
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