The purpose of this study is to determine the efficacy and safety of the administration of cyclosporine and prednisolone acetate compared to placebo in the treatment of allergic conjunctivitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
716
Solution of Cyclosporine (high dose) administered during 28 days
Solution of Cyclosporine (low dose) administered during 28 days
Suspension of Prednisolone Acetate administered during 28 days
ORA
Andover, Massachusetts, United States
Diary assessment of signs and symptoms of ocular allergy
Patient-reported ocular itching and redness
Time frame: During the 28 days of treatment
Diary and office assessments of various ocular and nasal allergy signs and symptoms
Patient-reported ocular itching and redness, lid swelling, tearing and nasal itching Investigator assessments of ocular redness and chemosis
Time frame: During 28 days of treatment
Safety
Ocular tolerance and adverse events
Time frame: During the 28 days of treatment
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Placebo solution administered during 28 days