search
Back to results

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

Primary Purpose

Keratoconjunctivitis, Vernal

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
N-acetyl-aspartyl-glutamate (NAAXIA Sine)
Sponsored by
Laboratoires Thea
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconjunctivitis, Vernal

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

    Outcomes

    Primary Outcome Measures

    ECP tear concentration

    Secondary Outcome Measures

    Tolerance

    Full Information

    First Posted
    July 26, 2006
    Last Updated
    July 26, 2006
    Sponsor
    Laboratoires Thea
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00357019
    Brief Title
    Study of the Clinical and Biological Efficacity of NAAXIA SINE® in Vernal Keratoconjunctivitis
    Official Title
    Study of the Clinical and Biological Efficacity of NAAXIA SINE® in Vernal Keratoconjunctivitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2002 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Laboratoires Thea

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Keratoconjunctivitis, Vernal

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    N-acetyl-aspartyl-glutamate (NAAXIA Sine)
    Primary Outcome Measure Information:
    Title
    ECP tear concentration
    Secondary Outcome Measure Information:
    Title
    Tolerance

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andréa LEONARDI, Professor
    Organizational Affiliation
    Clinica Oculistica, Padova (Italy)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17585003
    Citation
    Leonardi A, Bremond-Gignac D, Bortolotti M, Violato D, Pouliquen P, Delval L, Grouin JM, Fregona IA. Clinical and biological efficacy of preservative-free NAAGA eye-drops versus levocabastine eye-drops in vernal keratoconjunctivitis patients. Br J Ophthalmol. 2007 Dec;91(12):1662-6. doi: 10.1136/bjo.2007.117515. Epub 2007 Jun 21.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs