- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00357019
Study of the Clinical and Biological Efficacity of NAAXIA SINE® in Vernal Keratoconjunctivitis
July 26, 2006 updated by: Laboratoires Thea
To assess the clinical and biological efficacity of preservative free NAAGA eyes drops in vernal keratoconjunctivitis
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
ECP tear concentration
|
Secondary Outcome Measures
Outcome Measure |
---|
Tolerance
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andréa LEONARDI, Professor, Clinica Oculistica, Padova (Italy)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2001
Study Completion
October 1, 2002
Study Registration Dates
First Submitted
July 26, 2006
First Submitted That Met QC Criteria
July 26, 2006
First Posted (Estimate)
July 27, 2006
Study Record Updates
Last Update Posted (Estimate)
July 27, 2006
Last Update Submitted That Met QC Criteria
July 26, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Hypersensitivity, Immediate
- Eye Diseases
- Hypersensitivity
- Conjunctivitis
- Conjunctival Diseases
- Keratitis
- Corneal Diseases
- Conjunctivitis, Allergic
- Keratoconjunctivitis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neuroprotective Agents
- Protective Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Isospaglumic acid
Other Study ID Numbers
- TPO 09/99 NAAXIA SINE Phase IV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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