Keratoconjunctivitis, VernalPhase 4NCT00357019
Study of the Clinical and Biological Efficacity of NAAXIA SINE® in Vernal Keratoconjunctivitis
A Phase 4 study testing N-acetyl-aspartyl-glutamate (NAAXIA Sine) in people with Keratoconjunctivitis, Vernal, run by Laboratoires Thea.
Trial summary
To assess the clinical and biological efficacity of preservative free NAAGA eyes drops in vernal keratoconjunctivitis Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Keratoconjunctivitis, Vernal
- What is being tested?
- N-acetyl-aspartyl-glutamate (NAAXIA Sine)
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 2001to Oct 2002
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
About this study
To assess the clinical and biological efficacity of preservative free NAAGA eyes drops in vernal keratoconjunctivitis
Read the 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.
- Conditions
- Keratoconjunctivitis, Vernal
- Being tested
- N-acetyl-aspartyl-glutamate (NAAXIA Sine)
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl-aspartyl-glutamate (NAAXIA Sine)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
ECP tear concentration
Secondary outcomes (1)
Tolerance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2006 (estimated)
- Study startApr 2001
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Keratoconjunctivitis, VernalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andréa LEONARDI, Professor, Principal investigator, Clinica Oculistica, Padova (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357019
- Sponsor's protocol ID
- TPO 09/99 NAAXIA SINE Phase IV
- Status last verified
- Jul 2006
- First submitted
- 26 Jul 2006
- Last updated
- 27 Jul 2006
- Results posted
- No
Publications
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.
PubMed 17585003
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Clinical and Biological Efficacity of NAAXIA SINE® in Vernal Keratoconjunctivitis
- ClinicalTrials.gov ID
- NCT00357019
- Acronym / sponsor ID
- TPO 09/99 NAAXIA SINE Phase IV
- Conditions
- Keratoconjunctivitis, Vernal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- Apr 2001
- Study completion
- Oct 2002
- First posted
- 27 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetyl-aspartyl-glutamate (NAAXIA Sine) | Drug | – |
Primary outcome
ECP tear concentration
1 secondary outcome
Tolerance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2006.
- Derived from this study: PubMed 17585003Leonardi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andréa LEONARDI, Professor principal investigator
Clinica Oculistica, Padova (Italy)
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing N-acetyl-aspartyl-glutamate (NAAXIA Sine) in people with Keratoconjunctivitis, Vernal, run by Laboratoires Thea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECP tear concentration. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00357019, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2006.