NCT00357019

CompletedPhase 4

Study of the Clinical and Biological Efficacity of NAAXIA SI...

Laboratoires Thea Source

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Other study identifiers

Sponsor study identifier

TPO 09/99 NAAXIA SINE Phase IV

Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

0 countries

Sites

N/A

Timeline

Study Start

April 2001

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

October 2002

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): Not reported
Study completion date: October 2002
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2001
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
October 2002
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
July 26, 2006
Actual (reported)
First Posted
July 27, 2006
Actual (reported)

Last Updated: July 27, 2006
Status Verified: July 2006
Last Update Submitted: July 26, 2006

Conditions

Keratoconjunctivitis, Vernal

Outcome Measures

Primary Outcomes (1)

ECP tear concentration

Secondary Outcomes (1)

Tolerance

Interventions

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age4 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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)

Sponsors & Collaborators

Laboratoires Thea
Industrylead

Related Publications (1)

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.
PMID: 17585003DERIVED

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

isospaglumic acid

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

Andréa LEONARDI, Professor
Clinica Oculistica, Padova (Italy)
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

July 26, 2006

First Posted

July 27, 2006

Study Start

April 2001

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

October 2002

Date type not reported

NCT01068054

Efficacy Study of FK-506 and Cyclosporine in Vernal Keratoconjunctivits (VKC)

Phase 2/3Completed

NCT00426023

Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis

Phase 3Completed

NCT00445120

Lactobacillus Rhamnosus GG Oral Treatment Efficacy on Vernal Keratoconjunctivitis Treatment

Phase 2/3Completed

NCT05076084

Evaluation of the Efficacy and Safety of Tacrolimus Drops in Children With Vernal Keratoconjunctivitis

Completed

NCT06913790

Evaluation of Central Corneal Thickness in Patients With Vernal Keratoconjunctivitis Using Topical Steroids

Active Not Recruiting

NCT01751126

Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis

Phase 3Completed

age \>= 4 years old

You may not qualify if:

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).

Contact the study team to confirm eligibility.

This date has not been verified as actual or estimated.

Last Updated

July 27, 2006

Record last verified: 2006-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00357019
Data provider: ClinicalTrials.gov
Source updated: 2006-07-27
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:43 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record