Study of the Clinical and Biological Efficacity of NAAXIA SINE® in Vernal Keratoconjunctivitis

Laboratoires Thea

Overview

To assess the clinical and biological efficacity of preservative free NAAGA eyes drops in vernal keratoconjunctivitis

The objective of this pilot study is to evaluate the clinical and biological efficacy of preservative free NAAGA eyedrops in VKC -by in particular the levels of ECP and MPO in tears- comparatively to the activity of levocabastine eyedrops.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Keratoconjunctivitis, Vernal

Interventions

N-acetyl-aspartyl-glutamate (NAAXIA Sine)DRUG

Eligibility

Sex: ALLMin age: 4 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with vernal keratoconjunctivitis, * mild or moderate : clinical score \>3 and \<= 14, calculated from 4 major symptoms (itching, tearing, photophobia, foreign body sensation) and 6 major clinical signs (conjunctival erythema, conjunctival chemosis, discharge, papillae, limbal infiltrates and corneal epithelial disease) * age \>= 4 years old Exclusion Criteria: * no occurrence of ocular trauma or infection (within the 3 months preceding the study), * no ocular medical treatment (topical or not) within the 5 days preceding the study, * no ocular laser (within the 3 previous months), * no ocular surgery (within the previous year), * patient who signs the informed consent form (or his/her parents or legal guardian in the case of underage patient).

Outcomes

Primary Outcomes

ECP tear concentration

Secondary Outcomes

Tolerance

Data from ClinicalTrials.gov

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