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

Keratoconjunctivitis, Vernal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357019
• Other study ID #: TPO 09/99 NAAXIA SINE Phase IV
• Status: Completed
• Phase: Phase 4
• First received: July 26, 2006
• Last updated: July 26, 2006
• Start date: April 2001
• Est. completion date: October 2002

Study information

• Verified date: July 2006
• Source: Laboratoires Thea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis, Allergic
• Keratoconjunctivitis
• Keratoconjunctivitis, Vernal

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ECP tear concentration
Secondary	Tolerance