- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00328653
Efficacy and Tolerance of Nova22007 Versus Vehicle in Patients With Vernal Keratoconjunctivitis (VKC)
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75018
- Groupe hospitalier Bichat-Claude Bernard
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: NOVA22007 0.05%
four times daily
|
|
Experimental: NOVA22007 0.1%
four times daily
|
|
Sham Comparator: Vehicle
administered four times daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Rating of Subjective Symptoms of VKC in Period I
Time Frame: Week 4
|
The primary criteria of the trial was the overall rating of subjective symptoms in ocular symptoms of VKC as compared to Baseline and assessed at Week 4 (Month 1) based on a five-point scale based on BenEzra trial (BenEzra 1986):
|
Week 4
|
Overall Rating of Objective Symptoms of VKC in Period I
Time Frame: Week 4
|
Overall rating of objective signs was to be assessed under the slit lamp by the Investigator and recorded on a five-point scale based on BenEzra trial (BenEzra 1986):
|
Week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mean Daily Number of Unpreserved Artificial Tears Instillations in Period I
Time Frame: Up to Month1
|
Up to Month1
|
|
Ocular Tolerance in Period I
Time Frame: Up to Month1
|
Are the tested eye drops (other than concomitant tear substitute ) comfortable?
|
Up to Month1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David BenEzra, Pf, Haddassah University Hospital
- Study Director: Christophe Baudouin, Pf., Hôpital des XV-XX 28 rue de Charenton 75012 Paris
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Hypersensitivity, Immediate
- Eye Diseases
- Hypersensitivity
- Conjunctival Diseases
- Keratitis
- Corneal Diseases
- Conjunctivitis
- Conjunctivitis, Allergic
- Keratoconjunctivitis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Antifungal Agents
- Calcineurin Inhibitors
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- NOVATIVE - NVG05L101
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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