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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

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

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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.
Estimated Study Start Date : March 31, 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
HA
Other Name: HA




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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03874429


Contacts
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Contact: Marielle ESTRADE 0473989539 marielle.estrade@theapharma.com
Contact: Lydia Bresson 0473989507 lydia.bresson@theapharma.com

Locations
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France
C.H.N.O des XV-XX
Paris, France, 75012
Sponsors and Collaborators
Laboratoires Thea

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Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT03874429     History of Changes
Other Study ID Numbers: LT2259-001
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases