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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.
Sponsor:
Information provided by (Responsible Party):
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT01568593
First received: March 29, 2012
Last updated: October 24, 2014
Last verified: October 2014
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • Global Ocular Staining (With Oxford Scale - Ranges :0-15) [ Time Frame: 35 days ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568593

Locations
France
Paris, France
Sponsors and Collaborators
Laboratoires Thea
  More Information

No publications provided

Responsible Party: Laboratoires Thea
ClinicalTrials.gov 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: October 24, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Syndrome
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Disease
Eye Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014