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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02023268
• Date of registration: 23/12/2013
• Prospective Registration: No
• Primary sponsor: Laboratoires Thea
• Public title: Efficacy and Safety of T2762 and Vismed® in Dry Eye Syndrome
• Scientific title: Phase III: Comparison of the Efficacy and Safety of T2762 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
• Date of first enrolment: December 2013
• Target sample size: 105
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02023268
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
• Phase: Phase 3

Countries of recruitment

France

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Dry Eye Syndrome

Intervention(s)

Device: Vismed®

Device: T2762

Primary Outcome(s)

Global Ocular Staining (With Oxford Scale - Ranges : 0-15) [Time Frame: Baseline and Day 35]

Secondary ID(s)

LT2762-PIII-08/13

2013-A01292-43

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/04/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02023268