A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to Severe Dry Eye Syndrome
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
482
Ciclosporin 0.1% Ophthalmic Emulsions
Vehicle
Hôpital des XV-XX
Paris, Île-de-France Region, France
Corneal fluorescein staining (on modified Oxford scale)
Time frame: Approximately 26 weeks
Patient's global score of all symptoms of ocular discomfort unrelated to study medication instillation, using a visual analog scale (VAS) ranging from 0%-100%
Time frame: Approximately 26 weeks
• Ocular Symptom Disease Index© (OSDI©) questionnaire • Percentage of complete responder to corneal fluorescein staining (on modified Oxford scale), i.e. with corneal staining score =0 • Patient's score of each symptom of ocular discomfort unrelated to
Time frame: Approximately 26 weeks
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