Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome

March 7, 2016 updated by: Laboratoires Thea
Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 3

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

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 selection.

Exclusion Criteria:

  • Best far corrected visual acuity < 1/10
  • Severe blepharitis
  • Severe Dry Eye
  • Eyelid malposition
  • Known hypersensitivity to one of the components of the study medications or test products.
  • Pregnant or breast-feeding woman.
  • Woman of childbearing age (neither menopausal, nor hysterectomised, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms).
  • Inability of patient to understand the study procedures and thus inability to give informed consent.
  • Non compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance).
  • Already included once in this study.
  • Patient under guardianship.

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: T2750
Device: T2750
1 drop in each eye 3 to 6 times daily during 84 days
Active Comparator: Vismed
Device: Vismed
1 drop in each eye 3 to 6 times daily during 84 days

What is the study measuring?

Primary Outcome Measures

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

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

March 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

March 29, 2012

First Submitted That Met QC Criteria

March 29, 2012

First Posted (Estimate)

April 2, 2012

Study Record Updates

Last Update Posted (Estimate)

April 4, 2016

Last Update Submitted That Met QC Criteria

March 7, 2016

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT2750-PIII-10/11

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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