Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
NCT ID: NCT01568593
Last Updated: 2016-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
93 participants
INTERVENTIONAL
2012-03-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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T2750
T2750
1 drop in each eye 3 to 6 times daily during 84 days
Vismed
Vismed
1 drop in each eye 3 to 6 times daily during 84 days
Interventions
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T2750
1 drop in each eye 3 to 6 times daily during 84 days
Vismed
1 drop in each eye 3 to 6 times daily during 84 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Laboratoires Thea
INDUSTRY
Responsible Party
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Locations
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Paris, , France
Countries
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Other Identifiers
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LT2750-PIII-10/11
Identifier Type: -
Identifier Source: org_study_id
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