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

July 26, 2006 updated by: Laboratoires Thea

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Tolerance
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires Thea

Investigators

  • Principal Investigator: Catherine CREUZOT-GARCHER, Professor, CHU of Dijon, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion

May 1, 2005

Study Registration Dates

First Submitted

July 25, 2006

First Submitted That Met QC Criteria

July 26, 2006

First Posted (Estimate)

July 27, 2006

Study Record Updates

Last Update Posted (Estimate)

July 27, 2006

Last Update Submitted That Met QC Criteria

July 26, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LT1675-PIICA-04/04 PHASE II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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