This study evaluates the efficacy and safety of Cyclosporine 0.010% eye drops in the treatment of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye). The study consists of a double-masked phase, and open-labeled phase, and an open-labeled maintenance phase. For the first 3 months of the study, patients will receive either masked Cyclosporine 0.010% eye drops or vehicle four times daily; for the next 6 months, patients may receive open-labeled Cyclosporine 0.010% eye drops four times daily. At month 9, patients who are in remission, will be re-randomized to receive either open-labeled Cyclosporine 0.010% eye drops four times daily or twice daily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
176
Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
Unnamed facility
Bakersfield, California, United States
Unnamed facility
Randwick, New South Wales, Australia
Unnamed facility
Ottawa, Ontario, Canada
Unnamed facility
Prague, Czechia
Unnamed facility
Dijon, Burgundy, France
Unnamed facility
Munich, Bavaria, Germany
Unnamed facility
Bangalore, Karnataka, India
Unnamed facility
Tel Aviv, Israel
Unnamed facility
Rome, Italy
Unnamed facility
Wellington, New Zealand
...and 2 more locations
Percentage of Treatment Responders
Treatment responders are defined as patients with a ≥ 1 grade improvement from baseline in punctate corneal staining score and a ≥ 4 grade improvement from baseline in composite symptom score in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 (0 is ≤2 dots and 5 is \>316 dots (approximately) or ulcer/erosion). The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). The composite symptom score (0 to 15) is the sum of 5 symptoms (each symptom is assessed on a scale of 0=absent to 3=severe).
Time frame: Baseline, Month 2
Percentage of Punctate Corneal Staining Responders
Punctate corneal staining responders defined as patients achieving a punctate corneal staining score of 0 or 1 in the study eye. Punctate corneal staining is assessed on a scale of 0 to 5 where 0 is ≤2 dots, 1 is \>2 dots but ≤ 10 dots, 2 is \> 10 dots but ≤ 32 dots, 3 is \> 32 dots but ≤ 100 dots (approximately), 4 is \> 100 dots (approximately) but ≤ 316 dots (approximately), and 5 is \>316 dots (approximately) or ulcer/erosion.
Time frame: Month 2
Percentage of Patients With an Improvement in the Composite Symptom Score
Composite symptom score improvement is defined as a 4 or more grade decrease from baseline in composite symptom score in the study eye. The composite symptom score is based on 5 symptoms (itching, tearing, ocular discomfort, photophobia, mucous discharge). Each of the 5 symptoms is assessed on a scale of 0=absent to 3=severe. The composite symptom score is the sum of all 5 individual symptom scores, where 0 is no symptoms and 15 is the most severe symptoms.
Time frame: Baseline, Month 2
Percentage of Patients With an Improvement in the Punctate Corneal Staining Score
Punctate corneal staining improvement is defined as a 1 or more grade decrease from baseline in the study eye. The punctate corneal staining score is assessed on a scale of 0 to 5 where 0 is ≤2 dots, 1 is \>2 dots but ≤ 10 dots, 2 is \> 10 dots but ≤ 32 dots, 3 is \> 32 dots but ≤ 100 dots (approximately), 4 is \> 100 dots (approximately) but ≤ 316 dots (approximately), and 5 is \>316 dots (approximately) or ulcer/erosion.
Time frame: Baseline, Month 2
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