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NCT02023268 Clinical Trial

Efficacy and Safety of T2762 and Vismed® in Dry Eye Syndrome

Dry Eye Syndrome Clinical Trial

Official title:
Phase III: Comparison of the Efficacy and Safety of T2762 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02023268
Other study ID # LT2762-PIII-08/13
Secondary ID 2013-A01292-43
Status Completed
Phase Phase 3
First received December 23, 2013
Last updated August 22, 2017
Start date December 2013
Est. completion date February 2015

Study information
Verified date November 2015
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome

Recruitment information / eligibility
Status Completed
Enrollment 105
Est. completion date February 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• T2762
1 drop in each eye 3 to 6 times daily during 84 days
• Vismed®
1 drop in each eye 3 to 6 times daily during 84 days

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Laboratoires Thea

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Global Ocular Staining (With Oxford Scale - Ranges : 0-15) 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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