Study of the Clinical and Biological Efficacity of NAAXIA... | NCT00357019

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

NCT00357019

Sponsor

Laboratoires Thea

Status

Completed

Last Update Posted

Jul 27, 2006Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Keratoconjunctivitis, Vernal

Interventions

N-acetyl-aspartyl-glutamate (NAAXIA Sine)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2001

Primary Completion Date

Not provided

Completion Date

Oct 2002

First Submitted Date

Jul 26, 2006

First Submission Date that Met QC Criteria

Jul 26, 2006

First Posted Date

Jul 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2006

Last Update Posted Date

Jul 27, 2006Estimated

Description Module

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 the activity of levocabastine eyedrops.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
N-acetyl-aspartyl-glutamate (NAAXIA Sine)	Drug

Measure	Description	Time Frame
ECP tear concentration

Measure	Description	Time Frame
Tolerance

Eligibility Module

Eligibility 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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andréa LEONARDI, Professor	Clinica Oculistica, Padova (Italy)	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17585003	Derived	Leonardi A, Bremond-Gignac D, Bortolotti M, Violato D, Pouliquen P, Delval L, Grouin JM, Fregona IA. Clinical and biological efficacy of preservative-free NAAGA eye-drops versus levocabastine eye-drops in vernal keratoconjunctivitis patients. Br J Ophthalmol. 2007 Dec;91(12):1662-6. doi: 10.1136/bjo.2007.117515. Epub 2007 Jun 21.

ID	Term
D003231	Conjunctivitis
D003229	Conjunctival Diseases
D005128	Eye Diseases
D006969	Hypersensitivity, Immediate