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

Condition(s) targeted: Allergic Conjunctivitis

Intervention: Olopatadine hydrochloride ophthalmic solution 0.1% (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Eriko Chono, Study Director, Affiliation: Alcon Research

The objective of this study is to further evaluate the safety of Olopatadine Ophthalmic Solution 0. 1% in Japanese children with allergic conjunctivitis.

Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Incidence of adverse events

Questionnaire about compliance with dosing instructions

Secondary outcome:

Changes in score of subjective symptoms and objective findings

Questionnaire about stinging after instillation

Minimum age: 7 Years. Maximum age: 15 Years. Gender(s): Both.

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

Contact Alcon Call Center For Trial Locations, Tokyo 1F, Japan

Starting date: March 2010
Last updated: May 11, 2015