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

Phase 4

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Olopatadine hydrochloride ophthalmic solution 0.1%

• Registration Number: NCT01109485
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-22
• Study First Posted: 2010-04-23
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-09
• Last Update Submitted: 2015-05-11
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Olopatadine	Olopatadine hydrochloride ophthalmic solution 0.1%	Olopatadine hydrochloride ophthalmic solution 0.1%

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	4 weeks
Questionnaire about compliance with dosing instructions	4 weeks	(1;always \>90% 2;often 75-90% 3;sometimes 50-75% 4;seldom \<50%)

Secondary Outcome Measures

Name	Time	Method
Changes in score of subjective symptoms and objective findings	4 weeks	(0;none 1;mild 2;moderate 3;severe)
Questionnaire about stinging after instillation	4 weeks	(1;none 2;mild 3;moderate 4;severe)

Trial Locations

Locations (1)

Contact Alcon Call Center For Trial Locations; 🇯🇵 Tokyo, Japan