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

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

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Key information

Conditions

Dry Eye Syndrome Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clermont-Ferrand, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T2762

Device

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

Primary outcomes

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

Time frame: Baseline and Day 35

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).

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2015
First posted: Dec 30, 2013
Registry last updated: Aug 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed