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Completed

NCT Number: NCT00357019

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

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

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Key information

Conditions

Keratoconjunctivitis, Vernal Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

N-acetyl-aspartyl-glutamate (NAAXIA Sine)

Drug

Primary outcomes

  1. ECP tear concentration

Secondary outcomes

  1. Tolerance

Sponsors and collaborators

Lead sponsor

Laboratoires Thea

Industry

Registry information

Important dates

Study start
2001
Study completion
2002
First posted
Jul 27, 2006
Registry last updated
Jul 27, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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