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

Allergic Conjunctivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109485
• Other study ID #: JPN-P-2010-1
• Status: Completed
• Phase: Phase 4
• First received: April 12, 2010
• Last updated: May 11, 2015
• Start date: March 2010
• Est. completion date: July 2011

Study information

• Verified date: September 2011
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 15 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Olopatadine hydrochloride ophthalmic solution 0.1%
1-2 drops 4 times per day

Locations

Country	Name	City	State
Japan	Contact Alcon Call Center For Trial Locations	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		4 weeks	Yes
Primary	Questionnaire about compliance with dosing instructions	(1;always >90% 2;often 75-90% 3;sometimes 50-75% 4;seldom <50%)	4 weeks	No
Secondary	Changes in score of subjective symptoms and objective findings	(0;none 1;mild 2;moderate 3;severe)	4 weeks	No
Secondary	Questionnaire about stinging after instillation	(1;none 2;mild 3;moderate 4;severe)	4 weeks	No