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Efficacy of T2259 in DED

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ClinicalTrials.gov Identifier: NCT03874429
Recruitment Status : Not yet recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Laboratoires Thea

Tracking Information
First Submitted Date  ICMJE March 12, 2019
First Posted Date  ICMJE March 14, 2019
Last Update Posted Date March 14, 2019
Estimated Study Start Date  ICMJE March 31, 2019
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2019)
evaluation of ocular staining grade [ Time Frame: Day 35 ]
Oxford score
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of T2259 in DED
Official Title  ICMJE Comparison of the Performance and Safety of T2259 Versus Vismed Multi in Dry Eye Patients With Superficial Keratitis.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Dry Eye Syndromes
Intervention  ICMJE
  • Device: T2259
    HA and Trealose
    Other Name: HA and Trealose
  • Device: Vismed multi
    HA
    Other Name: HA
Study Arms  ICMJE
  • Experimental: T2259
    1 drop in each eye 2 to 4 times daily
    Intervention: Device: T2259
  • Active Comparator: Vismed Multi
    1 drop in each eye 2 to 4 times daily
    Intervention: Device: Vismed multi
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 12, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marielle ESTRADE 0473989539 marielle.estrade@theapharma.com
Contact: Lydia Bresson 0473989507 lydia.bresson@theapharma.com
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03874429
Other Study ID Numbers  ICMJE LT2259-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laboratoires Thea
Study Sponsor  ICMJE Laboratoires Thea
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Laboratoires Thea
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP