Status:
COMPLETED
Study of the Clinical and Biological Efficacity of NAAXIA SINE® in Vernal Keratoconjunctivitis
Lead Sponsor:
Laboratoires Thea
Conditions:
Keratoconjunctivitis, Vernal
Eligibility:
All Genders
4+ years
Phase:
PHASE4
Brief Summary
To assess the clinical and biological efficacity of preservative free NAAGA eyes drops in vernal keratoconjunctivitis
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
End Date :
October 1 2002
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00357019
Start Date
April 1 2001
End Date
October 1 2002
Last Update
July 27 2006
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