Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome

Phase 3

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Device: T2750; Device: Vismed

• Registration Number: NCT01568593
• Lead Sponsor: Laboratoires Thea

Brief Summary

Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-29
• Study First Submitted QC: 2012-03-29
• Study First Posted: 2012-04-02
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-10
• Results First Submitted: 2014-10-07
• Results First Submitted QC: 2014-10-24
• Results First Posted: 2014-10-27
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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
• Eyelid malposition
• Known hypersensitivity to one of the components of the study medications or test products.
• Pregnant or breast-feeding woman.
• Woman of childbearing age (neither menopausal, nor hysterectomised, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms).
• Inability of patient to understand the study procedures and thus inability to give informed consent.
• Non compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance).
• Already included once in this study.
• Patient under guardianship.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T2750	T2750	-
Vismed	Vismed	-

Primary Outcome Measures

Name	Time	Method
Global Ocular Staining (With Oxford Scale - Ranges :0-15)	Baseline and 35 days	Change from baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)