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

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.
 
ClinicalTrials.gov Identifier: NCT00357019
Recruitment Status : Completed
First Posted : July 27, 2006
Last Update Posted : July 27, 2006
Sponsor:
Information provided by:
Laboratoires Thea

Study Description
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Brief Summary:
To assess the clinical and biological efficacity of preservative free NAAGA eyes drops in vernal keratoconjunctivitis

Condition or disease Intervention/treatment Phase
Keratoconjunctivitis, Vernal Drug: N-acetyl-aspartyl-glutamate (NAAXIA Sine) Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
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
Study Start Date : April 2001
Study Completion Date : October 2002

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. ECP tear concentration

Secondary Outcome Measures :
  1. Tolerance

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
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
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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
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Principal Investigator: Andréa LEONARDI, Professor Clinica Oculistica, Padova (Italy)
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00357019    
Other Study ID Numbers: TPO 09/99 NAAXIA SINE Phase IV
First Posted: July 27, 2006    Key Record Dates
Last Update Posted: July 27, 2006
Last Verified: July 2006
Additional relevant MeSH terms:
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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