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

This study has been completed.
Information provided by (Responsible Party):
Laboratoires Thea Identifier:
First received: March 29, 2012
Last updated: March 7, 2016
Last verified: October 2014
Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome

Condition Intervention Phase
Dry Eye Syndromes
Device: T2750
Device: Vismed
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome

Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • Global Ocular Staining (With Oxford Scale - Ranges :0-15) [ Time Frame: Baseline and 35 days ]
    Change from baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)

Enrollment: 93
Study Start Date: March 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: T2750 Device: T2750
1 drop in each eye 3 to 6 times daily during 84 days
Active Comparator: Vismed Device: Vismed
1 drop in each eye 3 to 6 times daily during 84 days


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01568593

Paris, France
Sponsors and Collaborators
Laboratoires Thea
  More Information

Responsible Party: Laboratoires Thea Identifier: NCT01568593     History of Changes
Other Study ID Numbers: LT2750-PIII-10/11
Study First Received: March 29, 2012
Results First Received: October 7, 2014
Last Updated: March 7, 2016

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Pathologic Processes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases processed this record on May 22, 2017