Status:
COMPLETED
Efficacy and Tolerance of Nova22007 Versus Vehicle in Patients With Vernal Keratoconjunctivitis (VKC)
Lead Sponsor:
Santen SAS
Conditions:
Conjunctivitis, Vernal
Eligibility:
All Genders
4+ years
Phase:
PHASE2
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00328653
Start Date
May 1 2006
Last Update
December 14 2021
Active Locations (1)
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1
Groupe Hospitalier Bichat-Claude Bernard
Paris, France, 75018