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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00328653
Recruitment Status : Completed
First Posted : May 22, 2006
Last Update Posted : August 21, 2008
Information provided by:
Santen SAS

Brief Summary:

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 or disease Intervention/treatment Phase
Conjunctivitis, Vernal Drug: cyclosporine Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : May 2006

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00328653

Groupe Hospitalier Bichat-Claude Bernard
Paris, France, 75018
Sponsors and Collaborators
Santen SAS
Principal Investigator: David BenEzra, Pf Haddassah University Hospital
Study Director: Christophe Baudoin, Pf. Hôpital des XV-XX 28 rue de Charenton 75012 Paris Identifier: NCT00328653     History of Changes
Other Study ID Numbers: NOVATIVE - NVG05L101
First Posted: May 22, 2006    Key Record Dates
Last Update Posted: August 21, 2008
Last Verified: August 2008

Keywords provided by Santen SAS:
vernal keratoconjunctivitis (VKC), eye, allergy, cyclosporin

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