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

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Food supplement (T1675)
Sponsored by
Laboratoires Thea
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    July 25, 2006
    Last Updated
    July 26, 2006
    Sponsor
    Laboratoires Thea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00357201
    Brief Title
    Efficacy of T1675 Versus Placebo in Patients With Bilateral Treated Moderate Dry Eye Syndrome
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Laboratoires Thea

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dry Eye Syndromes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Food supplement (T1675)
    Primary Outcome Measure Information:
    Title
    Total score of the lissamine green staining test in the right eye on Day 168 (Month 6).
    Secondary Outcome Measure Information:
    Title
    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
    Title
    Global efficacy
    Title
    Tolerance

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Catherine CREUZOT-GARCHER, Professor
    Organizational Affiliation
    CHU of Dijon, France
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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