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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2002-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Keratoconjunctivitis, Vernal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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N-acetyl-aspartyl-glutamate (NAAXIA Sine)

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Andréa LEONARDI, Professor

Role: PRINCIPAL_INVESTIGATOR

Clinica Oculistica, Padova (Italy)

References

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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.

Reference Type DERIVED

PMID: 17585003 (View on PubMed)

Other Identifiers

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TPO 09/99 NAAXIA SINE Phase IV

Identifier Type: -

Identifier Source: org_study_id