Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients

The objective of this study is to further evaluate the safety of Olopatadine Ophthalmic Solution 0.1% in Japanese children with allergic conjunctivitis.

Inclusion Criteria:

• Patients whose parents or guardians can issue informed consent
• Patients aged over 7 and less than 16 at the baseline
• Patients confirmed to show type I allergy
• Patients with allergic conjunctivitis
• Patients having subjective symptoms at the baseline (itching sensation, foreign body sensation, eye pain, etc.)

Exclusion Criteria:

• Patients having ocular itching sensation and injection caused by disease other than allergic conjunctivitis
• Patients having retinal detachment, diabetic retinopathy or progressive retinal disease
• Patients with a history of ocular infection, corneal herpes or relapsing corneal erosion of sudden onset or secondary to corneal injury
• Patients having received continuous treatment with corticosteroid within 3 months
• Patients having received immunotherapy
• Patients requiring continuous treatment of corticosteroid, immunosuppressors, non-steroidal anti-inflammatory agents, vasoconstrictors, anti-histamines, anti-allergy agents, herbal preparations indicated for "conjunctivitis" or any ophthalmic solution other than the test product
• Patients having undergone ocular laser therapy within 3 months
• Unilaterally blind patients (best corrected visual acuity: below 0.01)
• Patients with a history of allergy or hypersensitivity to olopatadine hydrochloride
• Patients necessitating the use of contact lens during the study period
• Other patients judged by the attending physician as inappropriate for study