Efficacy, Safety of T2769 in Dry Eye Disease

March 8, 2022 updated by: Laboratoires Thea

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

Efficacy of T2769 in Dry Eye Desease

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Multicenter and open study

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Mahdia, Tunisia, 5100
        • Hôpital Universitaire Tahar Sfar
      • Monastir, Tunisia, 5000
        • "Hôpital Universitaire Fattouma Bourguiba
      • Tunis, Tunisia
        • "Hôpital de Forces de Sécurité Intérieure La Marsa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: T2769
T2769 Ophthalmic solution patients treated with 1 drop in each eye 3 to 6 times daily
Other: T2769
At least 55 enrolled patients for at least 50 evaluable patients treated by T2769 for 42 days
Other Names:
  • Ophthalmic solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Symptomatology
Time Frame: Baseline and Day 42
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Thea

Investigators

  • Principal Investigator: Lamia El Fekih, Pr, fekihlamia63@gmail.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2018

Primary Completion (ACTUAL)

February 18, 2019

Study Completion (ACTUAL)

February 18, 2019

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

February 1, 2019

First Posted (ACTUAL)

February 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT2769-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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