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

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratoires Thea

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