Status:
COMPLETED
Efficacy of T1675 Versus Placebo in Patients With Bilateral Treated Moderate Dry Eye Syndrome
Lead Sponsor:
Laboratoires Thea
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
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 pa...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00357201
Start Date
November 1 2004
End Date
May 1 2005
Last Update
July 27 2006
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.