Dry Eye Syndromes
Conditions
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
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 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.
Interventions
Sponsors
Laboratoires Thea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total score of the lissamine green staining test in the right eye on Day 168 (Month 6). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Outcome results
None listed