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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00357201
Recruitment Status : Completed
First Posted : July 27, 2006
Last Update Posted : July 27, 2006
Sponsor:
Information provided by:
Laboratoires Thea

Tracking Information
First Submitted Date  ICMJE July 25, 2006
First Posted Date  ICMJE July 27, 2006
Last Update Posted Date July 27, 2006
Study Start Date  ICMJE November 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2006)
Total score of the lissamine green staining test in the right eye on Day 168 (Month 6).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of T1675 Versus Placebo in Patients With Bilateral Treated Moderate Dry Eye Syndrome
Official Title  ICMJE 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
Brief Summary 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Dry Eye Syndromes
Intervention  ICMJE Drug: Food supplement (T1675)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE May 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00357201
Other Study ID Numbers  ICMJE LT1675-PIICA-04/04 PHASE II
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Laboratoires Thea
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Catherine CREUZOT-GARCHER, Professor CHU of Dijon, France
PRS Account Laboratoires Thea
Verification Date July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP