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

• Status: Completed
• Trial end date: 2002-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratoires Thea
• Treatments: Isospaglumic acid; N-acetyl-1-aspartylglutamic acid

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).