Clinical trial NCT00328653: Efficacy and Tolerance of Nova22007 Versus Vehicle in Patients With Vernal Keratoconjunctivitis (VKC)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Conjunctivitis, Vernal
Keywords: vernal keratoconjunctivitis (VKC), eye, allergy, cyclosporin
Lead sponsor: Santen SAS
Sponsor class: INDUSTRY
First posted: 2006-05-22
Enrollment: 118
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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).

Primary outcomes:
measure: Overall Rating of Subjective Symptoms of VKC in Period I
timeFrame: Week 4
measure: Overall Rating of Objective Symptoms of VKC in Period I
timeFrame: Week 4
Secondary outcomes:
measure: Change in Mean Daily Number of Unpreserved Artificial Tears Instillations in Period I
timeFrame: Up to Month1
measure: Ocular Tolerance in Period I
timeFrame: Up to Month1
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Bichat-Claude Bernard
Study officials:
affiliation: Haddassah University Hospital
name: David BenEzra, Pf
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital des XV-XX 28 rue de Charenton 75012 Paris
name: Christophe Baudouin, Pf.
role: STUDY_DIRECTOR
References: