NCT00357019

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2001

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2006

Completed
Last Updated

July 27, 2006

Status Verified

July 1, 2006

First QC Date

July 26, 2006

Last Update Submit

July 26, 2006

Conditions

Keratoconjunctivitis, Vernal

Outcome Measures

Primary Outcomes (1)

  • ECP tear concentration

Secondary Outcomes (1)

  • Tolerance

Interventions

N-acetyl-aspartyl-glutamate (NAAXIA Sine)DRUG

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 17585003DERIVED

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

isospaglumic acid

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Andréa LEONARDI, Professor

    Clinica Oculistica, Padova (Italy)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 26, 2006

First Posted

July 27, 2006

Study Start

April 1, 2001

Study Completion

October 1, 2002

Last Updated

July 27, 2006

Record last verified: 2006-07