- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02023268
Efficacy and Safety of T2762 and Vismed® in Dry Eye Syndrome
August 22, 2017 updated by: Laboratoires Thea
Phase III: Comparison of the Efficacy and Safety of T2762 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome
Study Overview
Study Type
Interventional
Enrollment (Actual)
105
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
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Clermont-Ferrand, France
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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
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
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1 drop in each eye 3 to 6 times daily during 84 days
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Active Comparator: Vismed®
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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 Day 35
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Change from Baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome) Global Ocular Staining With the Oxford Scale measured surface damage to treated eyes(by T2762 or vismed). |
Baseline and Day 35
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
December 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
December 23, 2013
First Submitted That Met QC Criteria
December 23, 2013
First Posted (Estimate)
December 30, 2013
Study Record Updates
Last Update Posted (Actual)
August 24, 2017
Last Update Submitted That Met QC Criteria
August 22, 2017
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LT2762-PIII-08/13
- 2013-A01292-43 (Registry Identifier: Agence Nationale de Sécurité du Médicament et des produits de santé)
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.
Clinical Trials on Dry Eye Syndrome
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Olympic Ophthalmics, Inc.RecruitingMicroBlepharoexfoliation, NuLids, iTEAR100, iLIDS100, Blepharitis, Dry Eye SyndromeUnited States
-
Fidia Farmaceutici s.p.a.RecruitingDry Eye Syndrome (DES)Italy
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Instituto Universitario de Oftalmobiología Aplicada...Completed
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Santen SASCompletedModerate to Severe Dry Eye SyndromeFrance
-
AllerganCompletedDry Eye Syndrome | Dry Eye DiseaseUnited States
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Applied Science & Performance InstituteTrue Eye Experts - New Tampa; True Eye Experts - Lutz; True Eye Experts - South...CompletedDry Eye | Dry Eye SyndromesUnited States
-
Senju Pharmaceutical Co., Ltd.CompletedDry Eye Syndrome | Dry Eye DiseaseUnited States
-
ReGenTree, LLCCompletedDry Eye | Dry Eye SyndromesUnited States
-
OphRx Ltd.CompletedDry Eye SyndromesIsrael
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University of New MexicoWithdrawn
Clinical Trials on T2762
-
Laboratoires TheaTerminated