Paris, France
NCT Number: NCT01568593
Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome
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Notify MeKey information
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
T2750
Device1 drop in each eye 3 to 6 times daily during 84 days
Vismed
Device1 drop in each eye 3 to 6 times daily during 84 days
Primary outcomes
-
Global Ocular Staining (With Oxford Scale - Ranges :0-15)
Time frame: Baseline and 35 days
Change from baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)
Sponsors and collaborators
Lead sponsor
Laboratoires Thea
Industry
Registry information
Important dates
- Study start
- 2012
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Apr 2, 2012
- Registry last updated
- Apr 4, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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