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Efficacy, Safety of T2769 in Dry Eye Disease

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03830359
Recruitment Status : Completed
First Posted : February 5, 2019
Results First Posted : March 4, 2022
Last Update Posted : March 4, 2022
Sponsor:
Information provided by (Responsible Party):
Laboratoires Thea

Study Description
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Brief Summary:
Efficacy of T2769 in Dry Eye Desease

Condition or disease Intervention/treatment Phase
Dry Eye Syndrome Other: T2769 Not Applicable

Detailed Description:
Multicenter and open study
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Efficacy and Safety Assessment of T2769 in Patients With Moderate to Severe Dry Eye Syndrome
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : February 18, 2019
Actual Study Completion Date : February 18, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: T2769
T2769 Ophthalmic solution patients treated with 1 drop in each eye 3 to 6 times daily
 Other: T2769
At least 55 enrolled patients for at least 50 evaluable patients treated by T2769 for 42 days
Other Name: Ophthalmic solution


Outcome Measures
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Primary Outcome Measures :
  1. Ocular Symptomatology [ Time Frame: Baseline and Day 42 ]
    Change from baseline in ocular symptomatology on a Visual Analog Scale (0=No discomfort and 100=Maximal discomfort) at Day 42.


Eligibility Criteria
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Information from the National Library of Medicine

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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 prior to study screening

Exclusion Criteria:

  • Best far corrected visual acuity ≤ 2/10
  • Severe blepharitis Severe dry eye
Contacts and Locations
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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): NCT03830359


Locations
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Tunisia
Hôpital Universitaire Tahar Sfar
Mahdia, Tunisia, 5100
"Hôpital Universitaire Fattouma Bourguiba
Monastir, Tunisia, 5000
"Hôpital de Forces de Sécurité Intérieure La Marsa
Tunis, Tunisia
Sponsors and Collaborators
Laboratoires Thea
Investigators
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Principal Investigator: Lamia El Fekih, Pr fekihlamia63@gmail.com
  Study Documents (Full-Text)

Documents provided by Laboratoires Thea:
Study Protocol  [PDF] November 13, 2017
Statistical Analysis Plan  [PDF] July 4, 2019

More Information
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Responsible Party: Laboratoires Thea
ClinicalTrials.gov Identifier: NCT03830359    
Other Study ID Numbers: LT2769-001
First Posted: February 5, 2019    Key Record Dates
Results First Posted: March 4, 2022
Last Update Posted: March 4, 2022
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Syndrome
Disease
Pathologic Processes
Lacrimal Apparatus Diseases
Eye Diseases
 Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Ophthalmic Solutions
Pharmaceutical Solutions