Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
Laboratoires Thea Identifier:
First received: July 26, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted

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:

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.


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00357019

Sponsors and Collaborators
Laboratoires Thea
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 Identifier (NCT Number): 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:
Conjunctival Diseases
Corneal Diseases
Eye Diseases
N-acetyl-1-aspartylglutamic acid
Anti-Allergic Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Central Nervous System Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses processed this record on February 27, 2015