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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00357019
First Posted: July 27, 2006
Last Update Posted: July 27, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Laboratoires Thea
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Clinical and Biological Efficacity of NAAXIA SINE® in Vernal Keratoconjunctivitis

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357019


Sponsors and Collaborators
Laboratoires Thea
Investigators
Principal Investigator: Andréa LEONARDI, Professor Clinica Oculistica, Padova (Italy)
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00357019     History of Changes
Other Study ID Numbers: TPO 09/99 NAAXIA SINE Phase IV
First Submitted: July 26, 2006
First Posted: July 27, 2006
Last Update Posted: July 27, 2006
Last Verified: July 2006

Additional relevant MeSH terms:
Keratoconjunctivitis
Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Isospaglumic acid
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Anti-Allergic Agents