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NCT03874429 Clinical Trial

Efficacy of T2259 in DED

Dry Eye Syndromes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03874429
Other study ID # LT2259-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 24, 2019
Est. completion date March 25, 2021

Study information
Verified date June 2022
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 101
Est. completion date March 25, 2021
Est. primary completion date February 12, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• T2259
Sodium Hyaluronate and Trehalose
• Vismed multi
HA

Locations
Country Name City State
France C.H.N.O des XV-XX Paris

Sponsors (1)
Lead Sponsor Collaborator
Laboratoires Thea

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) Baseline and Day 35
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