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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-05-31

Brief Summary

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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

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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.

Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Food supplement (T1675)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Catherine CREUZOT-GARCHER, Professor

Role: PRINCIPAL_INVESTIGATOR

CHU of Dijon, France

Other Identifiers

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LT1675-PIICA-04/04 PHASE II

Identifier Type: -

Identifier Source: org_study_id