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

NCT01109485 | Completed Phase 4

• 1 other identifier: JPN-P-2010-1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Conjunctivitis

Keywords

Allergic conjunctivitis

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  4 weeks

• Questionnaire about compliance with dosing instructions

  (1;always \>90% 2;often 75-90% 3;sometimes 50-75% 4;seldom \<50%)

  4 weeks

Secondary Outcomes (2)

• Changes in score of subjective symptoms and objective findings

  4 weeks

• Questionnaire about stinging after instillation

  4 weeks

Study Arms (1)

Olopatadine

EXPERIMENTAL

Olopatadine hydrochloride ophthalmic solution 0.1%

Drug: Olopatadine hydrochloride ophthalmic solution 0.1%

Interventions

Olopatadine hydrochloride ophthalmic solution 0.1% DRUG

1-2 drops 4 times per day

Olopatadine

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center For Trial Locations

Tokyo, 1F, Japan

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Eriko Chono

  Alcon Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2010
• First Posted: April 23, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: May 12, 2015

Record last verified: 2011-09

Locations

JP (1)