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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Olopatadine Hydrochloride; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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