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Efficacy and Tolerance of Nova22007 Versus Vehicle in Patients With Vernal Keratoconjunctivitis (VKC)

This study has been completed.

Sponsored by: Novagali Pharma
Information provided by: Novagali Pharma
ClinicalTrials.gov Identifier: NCT00328653
  Purpose

The primary objective of this study is:

  • To assess the efficacy of Nova22007, a cyclosporine A (CsA), 0.05% and 0.1% versus vehicle in patients with vernal keratoconjunctivitis (VKC) after a 4-week treatment period.

The secondary objectives of this study are:

  • To compare the safety and ocular tolerance of Nova22007 0.05% and 0.1%;
  • To assess the long term safety and ocular tolerance of Nova22007 0.05% and 0.1%; and
  • To assess the decrease in frequency of concomitant artificial tears use.

Condition Intervention Phase
Conjunctivitis, Vernal
Drug: cyclosporine
Phase II
Phase III

ChemIDplus related topics:   Cyclosporine    Cyclosporin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Phase II/III, Multicenter, Double-Masked, Randomized, Parallel Group, Dose Ranging, Controlled Trial of Efficacy and Tolerance of Nova22007 (Cyclosporine A [CSA] 0.05% & 0.1% Ophthalmic Cationic Emulsion) Versus Vehicle in Patients With VKC

Further study details as provided by Novagali Pharma:

Estimated Enrollment:   114
Study Start Date:   May 2006

  Eligibility
Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • At least the two following signs, in at least one eye* (the same eye should fulfill both criteria):

    • Presence of giant papillae with a diameter ≥ 1 mm on the upper tarsal conjunctiva AND
    • Superficial keratitis
  • At least two of the following ocular symptoms with a score > 2 in at least one eye*: burning/stinging, tearing, itching, pain, sticky eyelids, foreign body sensation, mucus discharge, and photophobia.
  • Hyperemia score equal to or greater than 2.

Exclusion Criteria:

  • Concomitant corneal ulcer of infectious origin.
  • Active ocular herpes
  • Disease that could possibly interfere with the interpretation of the study results: active uveitis (defined by Tyndall score > 0), previous history of ocular hypertension or glaucoma, or condition incompatible with the frequent assessments needed by the study.
  • Active herpes.
  • History of malignancy or a recurrence in the last 5 years.
  • Abnormality of nasolacrimal drainage apparatus.
  • Concomitant disease not stabilized within 1 month before Screening Visit (e.g. diabetes with glycemia out of range, trouble with thyroid secretions, etc.) or judged by the investigator to be incompatible with the study (e.g. current systemic infections), or condition incompatible with the frequent assessments needed by the study.
  • Known hypersensitivity to one of the components of the investigational medicinal products (IMP) or test products.
  • Severe systemic allergy requiring systemic treatment at study entry.
  • Female of childbearing potential.
  • History of drug or alcohol addiction (> 50g/day, 5 glasses alcohol/day).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328653

Locations
France
Groupe Hospitalier Bichat-Claude Bernard    
      Paris, France, 75018

Sponsors and Collaborators
Novagali Pharma

Investigators
Principal Investigator:     David BenEzra, Pf     Haddassah University Hospital    
Study Director:     Christophe Baudoin, Pf.     Hôpital des XV-XX 28 rue de Charenton 75012 Paris    
  More Information


Study ID Numbers:   NOVATIVE - NVG05L101
First Received:   May 19, 2006
Last Updated:   August 20, 2008
ClinicalTrials.gov Identifier:   NCT00328653
Health Authority:   France: Afssaps - French Health Products Safety Agency;   Italy: The Italian Medicines Agency;   Spain: Spanish Agency of Medicines;   Turkey: Ministry of Health;   Israel: Israeli Health Ministry Pharmaceutical Administration;   Morocco: Ministry of Public Health

Keywords provided by Novagali Pharma:
vernal keratoconjunctivitis (VKC), eye, allergy, cyclosporin  

Study placed in the following topic categories:
Corneal Diseases
Cyclosporine
Conjunctivitis, Allergic
Clotrimazole
Miconazole
Eye Diseases
Tioconazole
Conjunctivitis
Keratoconjunctivitis
Vernal keratoconjunctivitis
Cyclosporins
Conjunctival Diseases
Hypersensitivity
Hypersensitivity, Immediate
Keratitis

Additional relevant MeSH terms:
Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Therapeutic Uses
Antifungal Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antirheumatic Agents
Immunosuppressive Agents
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008




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