Phase 3 N=93 Randomized Single-blind Treatment

Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome

Dry Eye Syndromes

Bottom Line

View on ClinicalTrials.gov: NCT01568593 ↗

Enrolled (actual)

Serious AEs

1.1%

Results posted

Oct 2014

Primary outcome: Primary: Global Ocular Staining (With Oxford Scale - Ranges :0-15) — -1.8; -2 scores on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: T2750 (Device); Vismed (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Laboratoires Thea
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Global Ocular Staining (With Oxford Scale - Ranges :0-15)	-1.8; -2	—

Summary

Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to severe 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 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.

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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.