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

Last updated: March 7, 2016
Sponsor: Laboratoires Thea
Overall Status: Completed

Phase

3

Condition

Sjogren's Syndrome

Eyelid Inflammation

Dry Eyes

Treatment

N/A

Clinical Study ID

NCT01568593
LT2750-PIII-10/11
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 tostudy selection.

Exclusion

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 testproducts.

  • 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 giveinformed consent.

  • Non compliant patient (e.g. not willing to attend the follow-up visits, way of lifeinterfering with compliance).

  • Already included once in this study.

  • Patient under guardianship.

Study Design

Total Participants: 93
Study Start date:
March 01, 2012
Estimated Completion Date:
March 31, 2013

Connect with a study center

  • Paris,
    France

    Site Not Available

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