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

Thea Pharma

Status and phase: Completed; Phase 3

Conditions: Dry Eye Syndromes

Treatments: Device: Vismed; Device: T2750

Study type: Interventional

Funder types: Industry

Identifiers

NCT01568593

LT2750-PIII-10/11

Details and patient eligibility

About

Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome

Enrollment: 93 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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93 participants in 2 patient groups

T2750

Experimental group

Treatment:

Device: T2750

Vismed

Active Comparator group

Treatment:

Device: Vismed