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.

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).