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

NCT00357201 | Completed Phase 2

• 1 other identifier: LT1675-PIICA-04/04 PHASE II
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Total score of the lissamine green staining test in the right eye on Day 168 (Month 6).

Secondary Outcomes (3)

• 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

Interventions

Food supplement (T1675) DRUG

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent.
• Male or female aged from 18 to 90 years old.
• Known treated bilateral dry eye.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laboratoires Thea: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Catherine CREUZOT-GARCHER, Professor

  CHU of Dijon, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 25, 2006
• First Posted: July 27, 2006
• Study Start: November 1, 2004
• Study Completion: May 1, 2005
• Last Updated: July 27, 2006

Record last verified: 2006-07