Trial | NCT00357019  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    None
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 Started
Apr 30
2001
Study Completion
Oct 31
2002
Last Update
Jul 27
2006
Estimate

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

Criteria 

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).
No Results Posted