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

Alcon

Status and phase: Completed; Phase 4

Conditions: Allergic Conjunctivitis

Treatments: Drug: Olopatadine hydrochloride ophthalmic solution 0.1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01109485

JPN-P-2010-1

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 7 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Olopatadine

Experimental group

Description:

Olopatadine hydrochloride ophthalmic solution 0.1%

Treatment:

Drug: Olopatadine hydrochloride ophthalmic solution 0.1%