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

This study has been completed.
Sponsor:
Information provided by:
Laboratoires Thea
ClinicalTrials.gov Identifier:
NCT00357019
First received: July 26, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

No publications provided by Laboratoires Thea

Additional 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
Study First Received: July 26, 2006
Last Updated: July 26, 2006
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Keratoconjunctivitis
Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
N-acetyl-1-aspartylglutamic acid
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on May 19, 2013