Back to resultsComparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
T2750
Vismed
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
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 selection.
Exclusion Criteria:
- Best far corrected visual acuity < 1/10
- Severe blepharitis
- Severe Dry Eye
- Eyelid malposition
- Known hypersensitivity to one of the components of the study medications or test products.
- Pregnant or breast-feeding woman.
- Woman of childbearing age (neither menopausal, nor hysterectomised, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms).
- Inability of patient to understand the study procedures and thus inability to give informed consent.
- Non compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance).
- Already included once in this study.
- Patient under guardianship.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
T2750
Vismed
Arm Description
Outcomes
Primary Outcome Measures
Global Ocular Staining (With Oxford Scale - Ranges :0-15)
Change from baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01568593
Brief Title
Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
Official Title
Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Thea
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T2750
Arm Type
Experimental
Arm Title
Vismed
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
T2750
Intervention Description
1 drop in each eye 3 to 6 times daily during 84 days
Intervention Type
Device
Intervention Name(s)
Vismed
Intervention Description
1 drop in each eye 3 to 6 times daily during 84 days
Primary Outcome Measure Information:
Title
Global Ocular Staining (With Oxford Scale - Ranges :0-15)
Description
Change from baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)
Time Frame
Baseline and 35 days
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 selection.
Exclusion Criteria:
Best far corrected visual acuity < 1/10
Severe blepharitis
Severe Dry Eye
Eyelid malposition
Known hypersensitivity to one of the components of the study medications or test products.
Pregnant or breast-feeding woman.
Woman of childbearing age (neither menopausal, nor hysterectomised, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms).
Inability of patient to understand the study procedures and thus inability to give informed consent.
Non compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance).
Already included once in this study.
Patient under guardianship.
Facility Information:
City
Paris
Country
France
12. IPD Sharing Statement
Learn more about this trial
Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
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