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OpenTrials
Completed

NCT Number: NCT03874429

Efficacy of T2259 in DED

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

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

C.H.N.O des XV-XX

Paris, 75012, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

T2259

Device

Sodium Hyaluronate and Trehalose

Other names: Sodium Hyaluronate and Trehalose

Vismed multi

Device

HA

Other names: Sodium Hyaluronate

Primary outcomes

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

    Time frame: Baseline and Day 35

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

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Official study title

Comparison of the Performance and Safety of T2259 Versus Vismed Multi in Dry Eye Patients With Superficial Keratitis.

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 14, 2019
Registry last updated
Nov 1, 2023

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.

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