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

This study has been completed.
Sponsor:
Information provided by:
Novagali Pharma
ClinicalTrials.gov Identifier:
NCT00328653
First received: May 19, 2006
Last updated: August 20, 2008
Last verified: August 2008
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00328653     History of Changes
Other Study ID Numbers: NOVATIVE - NVG05L101
Study First Received: May 19, 2006
Last Updated: August 20, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Keratoconjunctivitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Keratitis
Corneal Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 24, 2014