Efficacy of T2259 in DED

October 31, 2023 updated by: Laboratoires Thea

Comparison of the Performance and Safety of T2259 Versus Vismed Multi in Dry Eye Patients With Superficial Keratitis.

The purpose of this study is to compare the performance and safety of T2259 versus Vismed Multi in dry eye patients with superficial keratitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

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

  • France
      • Paris, France, 75012
        • C.H.N.O des XV-XX

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

Description

Main 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 selection

Main exclusion Criteria:

  • Far best-corrected visual acuity≤2/10
  • Severe Blepharitis

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T2259
1 drop in each eye 2 to 4 times daily
Device: T2259
Sodium Hyaluronate and Trehalose
Other Names:
  • Sodium Hyaluronate and Trehalose
Active Comparator: Vismed Multi
1 drop in each eye 2 to 4 times daily
Device: Vismed multi
HA
Other Names:
  • Sodium Hyaluronate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : 0-15)
Time Frame: Baseline and Day 35
Change from baseline in the worse eye at Day 35 in Global Ocular staining (decrease of oxford score = better outcome)
Baseline and Day 35

Collaborators and Investigators

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

Sponsor

Laboratoires Thea

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)

April 24, 2019

Primary Completion (Actual)

February 12, 2021

Study Completion (Actual)

March 25, 2021

Study Registration Dates

First Submitted

March 12, 2019

First Submitted That Met QC Criteria

March 12, 2019

First Posted (Actual)

March 14, 2019

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT2259-001

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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