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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: April 17, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • Global ocular staining [ Time Frame: 35 days ] [ Designated as safety issue: No ]

Enrollment: 99
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
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
Last Updated: April 17, 2013
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
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
 Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases

ClinicalTrials.gov processed this record on May 23, 2013