Study of the Clinical and Biological Efficacity of NAAXIA SINE® in Vernal Keratoconjunctivitis - Full Text View

Sponsored by:	Laboratoires Thea
Information provided by:	Laboratoires Thea
ClinicalTrials.gov Identifier:	NCT00357019

Purpose

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

Condition	Intervention	Phase
Keratoconjunctivitis, Vernal	Drug: N-acetyl-aspartyl-glutamate (NAAXIA Sine)	Phase IV

Drug Information available for: N-Acetyl-1-aspartylglutamic acid Glutamic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study of the Clinical and Biological Efficacity of NAAXIA SINE® in Vernal Keratoconjunctivitis

Further study details as provided by Laboratoires Thea:

Primary Outcome Measures:

ECP tear concentration

Secondary Outcome Measures:

Tolerance

Study Start Date:	April 2001
Estimated Study Completion Date:	October 2002

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.

Eligibility

Ages Eligible for Study:	4 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357019

Sponsors and Collaborators

Laboratoires Thea

Investigators

Principal Investigator:

Andréa LEONARDI, Professor

Clinica Oculistica, Padova (Italy)

More Information

Publications indexed to this study:

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. Epub 2007 Jun 21.

Study ID Numbers:	TPO 09/99 NAAXIA SINE Phase IV
Study First Received:	July 26, 2006
Last Updated:	July 26, 2006
ClinicalTrials.gov Identifier:	NCT00357019
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Corneal Diseases
Conjunctivitis, Allergic
Eye Diseases
Conjunctivitis
Keratoconjunctivitis
Vernal keratoconjunctivitis
Conjunctival Diseases

Histamine
Hypersensitivity
N-acetyl-1-aspartylglutamic acid
Hypersensitivity, Immediate
Keratitis
Histamine phosphate

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Histamine Agents
Anti-Allergic Agents
Protective Agents

Neuroprotective Agents
Pharmacologic Actions
Histamine Antagonists
Autonomic Agents
Therapeutic Uses
Histamine H1 Antagonists
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009