Overview

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