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

Thea Pharma

Status and phase

Completed

Phase 4

Conditions

Keratoconjunctivitis, Vernal

Treatments

Drug: N-acetyl-aspartyl-glutamate (NAAXIA Sine)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00357019

TPO 09/99 NAAXIA SINE Phase IV

Details and patient eligibility

About

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

Full description

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.

Sex

All

Ages

4+ years old

Volunteers

No Healthy Volunteers

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).