Back to resultsEfficacy, Safety of T2769 in Dry Eye Disease
Primary Purpose
Dry Eye Syndrome
Status
Completed
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
T2769
Sponsored by
About this trial
This is an interventional other trial for Dry Eye Syndrome
Eligibility 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
Sites / Locations
- Hôpital Universitaire Tahar Sfar
- "Hôpital Universitaire Fattouma Bourguiba
- "Hôpital de Forces de Sécurité Intérieure La Marsa
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
T2769
Arm Description
T2769 Ophthalmic solution patients treated with 1 drop in each eye 3 to 6 times daily
Outcomes
Primary Outcome Measures
Ocular Symptomatology
Change from baseline in ocular symptomatology on a Visual Analog Scale (0=No discomfort and 100=Maximal discomfort) at Day 42.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03830359
Brief Title
Efficacy, Safety of T2769 in Dry Eye Disease
Official Title
Efficacy and Safety Assessment of T2769 in Patients With Moderate to Severe Dry Eye Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
February 18, 2019 (Actual)
Study Completion Date
February 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Thea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Efficacy of T2769 in Dry Eye Desease
Detailed Description
Multicenter and open study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T2769
Arm Type
Experimental
Arm Description
T2769 Ophthalmic solution patients treated with 1 drop in each eye 3 to 6 times daily
Intervention Type
Other
Intervention Name(s)
T2769
Other Intervention Name(s)
Ophthalmic solution
Intervention Description
At least 55 enrolled patients for at least 50 evaluable patients treated by T2769 for 42 days
Primary Outcome Measure Information:
Title
Ocular Symptomatology
Description
Change from baseline in ocular symptomatology on a Visual Analog Scale (0=No discomfort and 100=Maximal discomfort) at Day 42.
Time Frame
Baseline and Day 42
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lamia El Fekih, Pr
Organizational Affiliation
fekihlamia63@gmail.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Universitaire Tahar Sfar
City
Mahdia
ZIP/Postal Code
5100
Country
Tunisia
Facility Name
"Hôpital Universitaire Fattouma Bourguiba
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
Facility Name
"Hôpital de Forces de Sécurité Intérieure La Marsa
City
Tunis
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy, Safety of T2769 in Dry Eye Disease
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