Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

Efficacy of T2259 in DED

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03874429
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : August 14, 2019
Information provided by (Responsible Party):
Laboratoires Thea

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
Dry Eye Syndromes Device: T2259 Device: Vismed multi Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 5, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: T2259
1 drop in each eye 2 to 4 times daily
Device: T2259
HA and Trealose
Other Name: HA and Trealose

Active Comparator: Vismed Multi
1 drop in each eye 2 to 4 times daily
Device: Vismed multi
Other Name: HA

Primary Outcome Measures :
  1. evaluation of ocular staining grade [ Time Frame: Day 35 ]
    Oxford score

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03874429

Layout table for location contacts
Contact: Marielle ESTRADE 0473989539
Contact: Lydia Bresson 0473989507

Layout table for location information
C.H.N.O des XV-XX Recruiting
Paris, France, 75012
Contact: Christophe BAUDOUIN, Professor    00.33.(0)   
Principal Investigator: Christophe BAUDOUIN, Professor         
Sponsors and Collaborators
Laboratoires Thea

Layout table for additonal information
Responsible Party: Laboratoires Thea Identifier: NCT03874429    
Other Study ID Numbers: LT2259-001
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases