Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Olopatadine hydrochloride ophthalmic solution 0.1%
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring Allergic conjunctivitis
Eligibility 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
Sites / Locations
- Contact Alcon Call Center For Trial Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Olopatadine
Arm Description
Olopatadine hydrochloride ophthalmic solution 0.1%
Outcomes
Primary Outcome Measures
Incidence of adverse events
Questionnaire about compliance with dosing instructions
(1;always >90% 2;often 75-90% 3;sometimes 50-75% 4;seldom <50%)
Secondary Outcome Measures
Changes in score of subjective symptoms and objective findings
(0;none 1;mild 2;moderate 3;severe)
Questionnaire about stinging after instillation
(1;none 2;mild 3;moderate 4;severe)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01109485
Brief Title
Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
Allergic conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Olopatadine
Arm Type
Experimental
Arm Description
Olopatadine hydrochloride ophthalmic solution 0.1%
Intervention Type
Drug
Intervention Name(s)
Olopatadine hydrochloride ophthalmic solution 0.1%
Intervention Description
1-2 drops 4 times per day
Primary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
4 weeks
Title
Questionnaire about compliance with dosing instructions
Description
(1;always >90% 2;often 75-90% 3;sometimes 50-75% 4;seldom <50%)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Changes in score of subjective symptoms and objective findings
Description
(0;none 1;mild 2;moderate 3;severe)
Time Frame
4 weeks
Title
Questionnaire about stinging after instillation
Description
(1;none 2;mild 3;moderate 4;severe)
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eriko Chono
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Contact Alcon Call Center For Trial Locations
City
Tokyo
ZIP/Postal Code
1F
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients
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