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

Phase 3CompletedNCT02023268

Laboratoires Thea105 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

105

Conditions

Dry Eye Syndrome

Interventions

T2762DEVICE

1 drop in each eye 3 to 6 times daily during 84 days

Vismed®DEVICE

1 drop in each eye 3 to 6 times daily during 84 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Clermont-Ferrand, France

Outcomes

Primary Outcomes

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).

Time frame: Baseline and Day 35

Data from ClinicalTrials.gov

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