The objective of this study is to compare the efficacy of two different dosing regimen of NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of the formulation) administered four times a day in patients with severe vernal keratoconjunctivitis after 4 months of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
169
Sterile, ophthalmic cationic oil-in-water emulsion containing 1 mg/ml Ciclosporin.
Sterile, drug-free, cationic ophthalmic oil-in-water emulsion containing 0 mg/ml Ciclosporin.
Average Penalties Adjusted Composite Efficacy Score (CFS) Score Over the 4 Months
Efficacy was assessed every month during the 4-month treatment phase and compared with Baseline using a composite criterion based on: * Keratitis assessed by the modified Oxford scale (7-point ordinal scale, score 0, 0.5, and 1 to 5). On this modified scale, the score 0 corresponded to no staining dots and the score 0.5 to three or less staining dots. A CFS grade of 0 represented complete corneal clearing. * Need for rescue medication. * Occurrence of corneal ulceration. An efficacy score was calculated as follows: Patient's score at month X = CFS (Baseline) - CFS (Month X) + penalty (ies) Penalty for rescue medication: -1 (per course, with a maximum of 2 courses between 2 scheduled visits) Penalty for corneal ulceration: -1 (per occurrence). A positive value indicated improvement. The maximum CFS is five and the minimum cannot be set due to the number of rescue medication and ulceration which decreases the penalty adjusted CFS.
Time frame: over the 4 months
Best Corrected Distance Visual Acuity (BCDVA) in 4-month Randomized Period I
Best corrected distance visual acuity (BCDVA) was measured with the patient's best correction and recorded in LogMAR (log of the Minimum Angle of Resolution) A negative LogMar BCDVA measure shows an improvement, whereas positive values indicates poor vision.
Time frame: Up to Month4
Best Corrected Distance Visual Acuity (BCDVA) in 8-month Safety FU Period- Period II
Best corrected distance visual acuity (BCDVA) was measured with the patient's best correction and recorded in LogMAR (log of the Minimum Angle of Resolution) A negative LogMar BCDVA measure shows an improvement, whereas positive values indicate poor vision.
Time frame: Up to Month12
Number of Courses of Rescue Medication in Period I
Use of rescue medication: the total number of topical corticosteroid courses was assessed at each visit during the 4-month efficacy evaluation treatment period.
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Glendale, California, United States
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Irvine, California, United States
Rancho Cordova, CA, USA
Rancho Cordova, California, United States
Miami, FL, USA
Miami, Florida, United States
Zagreb, City of Zagreb, HR
Zagreb, City of Zagreb, Croatia
Marseille, Bouches-du-Rhône, FR
Marseille, Bouches-du-Rhône, France
Angers CEDEX 9, Maine-et-Loire, FR
Angers, Maine-et-Loire, France
Amiens CEDEX, Somme, FR
Amiens, Somme, France
Tours CEDEX 9, FR
Tours, France
Paris CEDEX 8, Île-de-France, FR
Paris, Île-de-France Region, France
...and 36 more locations
Time frame: Up to Month4