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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00357019
Other study ID # TPO 09/99 NAAXIA SINE Phase IV
Secondary ID
Status Completed
Phase Phase 4
First received July 26, 2006
Last updated July 26, 2006
Start date April 2001
Est. completion date October 2002

Study information

Verified date July 2006
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date October 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 4 Years and older
Eligibility 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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
N-acetyl-aspartyl-glutamate (NAAXIA Sine)


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Laboratoires Thea

Outcome

Type Measure Description Time frame Safety issue
Primary ECP tear concentration
Secondary Tolerance
See also
  Status Clinical Trial Phase
Completed NCT01068054 - Efficacy Study of FK-506 and Cyclosporine in Vernal Keratoconjunctivits (VKC) Phase 2/Phase 3