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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00357019

Enrollment

Unknown

Registered

2006-07-27

Start date

2001-04-30

Completion date

2002-10-31

Last updated

2006-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconjunctivitis, Vernal

Brief summary

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

Detailed 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.

Interventions

DRUGN-acetyl-aspartyl-glutamate (NAAXIA Sine)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame
ECP tear concentration	—

Secondary

Measure	Time frame
Tolerance	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026