Comparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome

March 6, 2017 updated by: Laboratoires Thea
The purpose of this study is to compare the efficacy and safety of T2762 versus Optive® in the treatment of moderate to severe Dry Eye Syndrome.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

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
      • Clermont-Ferrand, France, 63000
        • Laboratoires Thea

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 ≥ 18 years old.
  • Diagnosis of moderate to severe dry eye syndrome

Exclusion Criteria:

  • Pregnancy, lactation.
  • Childbearing potential woman who is not using a reliable method of contraception and is not surgically sterilised.
  • Inability of patient to understand the study procedures and thus inability to give informed consent.
  • Non-compliant patient
  • Participation in another clinical study at the same time as the present study.
  • Participation to the present study during the exclusion period of another clinical study.
  • Already included once in this study.
  • Ward of court.
  • Patient not covered by government health care scheme

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: T2762
One drop of T2762 in each eye 3 to 6 times daily
Device: T2762
One drop in each eye 3 to 6 times daily
Active Comparator: Optive
One drop of Optive in each eye 3 to 6 times daily
Device: Optive
One drop in each eye 3 to 6 times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of the symptomatology evaluation on a Visual Analogic Scale
Time Frame: Day 28
Day 28

Collaborators and Investigators

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

Sponsor

Laboratoires Thea

Investigators

  • Principal Investigator: Frank Larkin, Professor, Moorfields Eye Hospital -162 city road - London
  • Principal Investigator: Friedrich KRUSE, Professor, Augenklinik mit Poliklinik - Swabachanlage 6 - 91054 Erlangen

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

February 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

November 26, 2015

First Submitted That Met QC Criteria

November 26, 2015

First Posted (Estimate)

November 30, 2015

Study Record Updates

Last Update Posted (Actual)

March 8, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT2762-PIV-11/13

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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