Efficacy of T2259 in DED

Laboratoires Thea101 enrolled

Overview

The purpose of this study is to compare the performance and safety of T2259 versus Vismed Multi in dry eye patients with superficial keratitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

101

Conditions

Dry Eye Syndromes

Interventions

T2259DEVICE

Sodium Hyaluronate and Trehalose

Vismed multiDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Main 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 Main exclusion Criteria: * Far best-corrected visual acuity≤2/10 * Severe Blepharitis

Locations (1)

C.H.N.O des XV-XX

Paris, France

Outcomes

Primary Outcomes

Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : 0-15)

Change from baseline in the worse eye at Day 35 in Global Ocular staining (decrease of oxford score = better outcome)

Time frame: Baseline and Day 35

Data from ClinicalTrials.gov

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