Efficacy of T1675 Versus Placebo in Patients With Bilateral Treated Moderate Dry Eye Syndrome

This study has been completed.
Sponsor:
Information provided by:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT00357201
First received: July 25, 2006
Last updated: July 26, 2006
Last verified: July 2006
  Purpose

To evaluate the efficacy of a 6-month (± 14 days) dietary supplementation period with T1675, a per os omega 3 and omega 6 polyunsaturated essential fatty acid dietary formulation, versus placebo in patients with bilateral treated moderate dry eye syndrome


Condition Intervention Phase
Dry Eye Syndromes
Drug: Food supplement (T1675)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of T1675, a Per Os Omega 3 and Omega 6 Polyunsaturated Essential Fatty Acid Dietary Formulation Versus Placebo in Patients With Bilateral Treated Moderate Dry Eye Syndrome

Resource links provided by NLM:


Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:
  • Total score of the lissamine green staining test in the right eye on Day 168 (Month 6).

Secondary Outcome Measures:
  • Total score of the lissamine green staining test in the right eye on Day 0, Day 28 (Month 1), Day 84 (Month 3), Month 12, Month 18, Month 24, Month 30, and Month 36
  • Global efficacy
  • Tolerance

Study Start Date: November 2004
Estimated Study Completion Date: May 2005
Detailed Description:

The aim of the present study is to evaluate the efficacy of a 6-month (± 14 days) dietary supplementation period with T1675 versus placebo in patients with bilateral moderate dry eye syndrome already treated with tear substitutes, and to point out, through several parameters, the best efficacy parameter that could be used for a future clinical phase III study.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed and dated informed consent.
  • Male or female aged from 18 to 90 years old.
  • Known treated bilateral dry eye.
  • Dry eye syndrome confirmed by ocular examination with a fluorescein and/or lissamine green staining, BUT and Schirmer, performed within the last 12 months before Inclusion Visit, for both eyes.
  • Bilateral symptomatology suggestive of dry eye defined by: at least one of the following ocular symptoms suggestive of dry eye (burning, stinging, dryness feeling, sandy and/or gritty sensation, light sensitivity, reflex tearing, ocular fatigue) and Questioning on patient’s feeling (score >=3).
  • Fulfilling the following criteria of dry eye syndrome in both eyes defined by: Keratoconjunctivitis defined by a lissamine green score ≥ 4 (Van Bijsterveld score) and Schirmer test <= 10 mm in 5 min or BUT < 10 s

Exclusion Criteria:

  • severe dry eye symptom
  • eyelid dysfunction
  • severe progressive rosacea
  • any relevant ocular anomaly interfering with ocular surface
  • best corrected far visual acuity <= 1/10
  • history of ocular allergy
  • traumatism, infection, inflammation within last 3 months
  • ocular surgery and laser within the last 3 months
  • lasik, laser, PKR within the last 12 months
  • contact lenses
  • any concomitant nutritive supplementation, vitamins
  • any topical concomitant treatment
  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: NCT00357201

Sponsors and Collaborators
Laboratoires Thea
Investigators
Principal Investigator: Catherine CREUZOT-GARCHER, Professor CHU of Dijon, France
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00357201     History of Changes
Other Study ID Numbers: LT1675-PIICA-04/04 PHASE II
Study First Received: July 25, 2006
Last Updated: July 26, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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 September 14, 2014