Clinical Evaluation of 0.1% Olopatadine Hydrochloride Oph... | NCT01109485

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

NCT01109485

Sponsor

Alcon Research

Status

Completed

Last Update Posted

May 12, 2015Estimated

Enrollment

42Actual

Phase

Phase 4

Conditions

Allergic Conjunctivitis

Interventions

Olopatadine hydrochloride ophthalmic solution 0.1%

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Apr 12, 2010

First Submission Date that Met QC Criteria

Apr 22, 2010

First Posted Date

Apr 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2015

Last Update Posted Date

May 12, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Olopatadine	Experimental	Olopatadine hydrochloride ophthalmic solution 0.1%	Drug: Olopatadine hydrochloride ophthalmic solution 0.1%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Olopatadine hydrochloride ophthalmic solution 0.1%	Drug	1-2 drops 4 times per day	Olopatadine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003231	Conjunctivitis
D003229	Conjunctival Diseases
D005128	Eye Diseases
D006969	Hypersensitivity, Immediate