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Efficacy of T2259 in DED

Sponsor
Laboratoires Thea (Industry)
Overall Status
Completed
CT.gov ID
NCT03874429
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
25.6
Actual Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: T2259
  • Device: Vismed multi
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
Comparison of the Performance and Safety of T2259 Versus Vismed Multi in Dry Eye Patients With Superficial Keratitis.
Actual Study Start Date :
Feb 5, 2019
Actual Primary Completion Date :
Feb 12, 2021
Actual Study Completion Date :
Mar 25, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: T2259

1 drop in each eye 2 to 4 times daily

Device: T2259
HA and Trealose
Other Names:
  • HA and Trealose

    		•
    Active Comparator: Vismed Multi

    1 drop in each eye 2 to 4 times daily

    Device: Vismed multi
    HA
    Other Names:
  • HA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. evaluation of ocular staining grade [Day 35]

      Oxford score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Exclusion Criteria:

    • Far best-corrected visual acuity≤2/10

    • Severe Blepharitis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 C.H.N.O des XV-XX Paris France 75012

    Sponsors and Collaborators

    • Laboratoires Thea

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Laboratoires Thea
    ClinicalTrials.gov Identifier:
    NCT03874429
    Other Study ID Numbers:
    • LT2259-001
    First Posted:
    Mar 14, 2019
    Last Update Posted:
    Jul 7, 2021
    Last Verified:
    Sep 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca

    Study Results

    No Results Posted as of Jul 7, 2021