Phase 3
Completed N=93
Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
Dry Eye Syndromes
Source: ClinicalTrials.gov NCT01568593 ↗
Enrolled (actual)
93
Serious AEs
1.1%
Results posted
Oct 2014
Primary outcomePrimary: Global Ocular Staining (With Oxford Scale - Ranges :0-15) — -1.8; -2 scores on a scale
Summary
Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Ocular Staining (With Oxford Scale - Ranges :0-15) |
-1.8; -2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01568593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.