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

Dry Eye Syndromes Clinical Trial

Official title:

Evaluation of the Efficacy of 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357201
• Other study ID #: LT1675-PIICA-04/04 PHASE II
• Status: Completed
• Phase: Phase 2
• First received: July 25, 2006
• Last updated: July 26, 2006
• Start date: November 2004
• Est. completion date: May 2005

Study information

• Verified date: July 2006
• Source: Laboratoires Thea
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• Food supplement (T1675)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total score of the lissamine green staining test in the right eye on Day 168 (Month 6).
Secondary	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
Secondary	Global efficacy
Secondary	Tolerance