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

Phase 4

Completed

• Conditions: Keratoconjunctivitis, Vernal

• Registration Number: NCT00357019
• Lead Sponsor: Laboratoires Thea

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.

Study Timeline

• Study Start: 2001-04
• Study Completion: 2002-10
• Status Verified: 2006-07
• Study First Submitted: 2006-07-26
• Study First Submitted QC: 2006-07-26
• Last Update Submitted: 2006-07-26
• Study First Posted: 2006-07-27
• Last Update Posted: 2006-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ECP tear concentration

Secondary Outcome Measures

Name	Time	Method
Tolerance