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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01568593
• Date of registration: 29/03/2012
• Prospective Registration: No
• Primary sponsor: Laboratoires Thea
• Public title: Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
• Scientific title: Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
• Date of first enrolment: March 2012
• Target sample size: 93
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01568593
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

France

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Dry Eye Syndromes

Intervention(s)

Device: Vismed

Device: T2750

Primary Outcome(s)

Global Ocular Staining (With Oxford Scale - Ranges :0-15) [Time Frame: Baseline and 35 days]

Secondary ID(s)

LT2750-PIII-10/11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/10/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01568593