Study of Olopatadine HCl Ophthalmic Solutions Compared to... | NCT00987272

Studies
Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis in Japanese Subjects

NCT00987272

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Jul 31, 2014Estimated

Enrollment

267Actual

Phase

Phase 3

Conditions

Allergic Conjunctivitis

Interventions

Olopatadine Hydrochloride Ophthalmic Solution, 0.2%
Olopatadine Hydrochloride Ophthalmic Solution, 0.1%
Olopatadine 0.2% Vehicle
Olopatadine 0.1% Vehicle

Countries

Not provided

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

Status Module

Record Verification Date

Jul 2014

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

Oct 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Sep 28, 2009

First Submission Date that Met QC Criteria

Sep 29, 2009

First Posted Date

Sep 30, 2009Estimated

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

Jul 28, 2014

Certification/Extension First Submitted that Passed QC Review

Jul 28, 2014

Certification/Extension First Posted Date

Jul 31, 2014Estimated

Last Update Submitted Date

Jul 28, 2014

Last Update Posted Date

Jul 31, 2014Estimated

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

Description Module

Brief Summary

The purpose of the study is to demonstrate safety and efficacy of Olopatadine 0.2% compared to its vehicle in Japanese subjects in the treatment of acute allergen-mediated conjunctivitis using the conjunctival allergen challenge (CAC) test.

Detailed Description

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

267Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pataday+Pataday Vehicle	Experimental	Olopatadine Hydrochloride Ophthalmic Solution 0.2%, 1 drop in 1 eye and Olopatadine 0.2% Vehicle in the contralateral eye	Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2% Drug: Olopatadine 0.2% Vehicle
Patanol+Patanol Vehicle	Active Comparator	Olopatadine Hydrochloride Ophthalmic Solution, 0.1%, 1 drop in 1 eye and Olopatadine 0.1% Vehicle in the contralateral eye	Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.1% Drug: Olopatadine 0.1% Vehicle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%	Drug		Pataday+Pataday Vehicle	PATADAY®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Ocular Itching Score		Day 0 of treatment: 3, 5, and 10 minutes post CAC

Secondary Outcomes

Measure	Description	Time Frame
Mean Total Redness Score		Day 0 of treatment: 3, 10, 20 minutes post-CAC

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Japanese ethnicity.
Seasonal Allergic Conjunctivitis--asymptomatic.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Manifest signs and symptoms of clinically active allergic conjunctivitis in either eye (>1 for redness in any of the 3 vessels beds - conjunctival, episcleral, ciliary - or itching >0) at the start of any visit.
Other protocol-defined exclusion criteria may apply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pamela Smith, BS	Alcon Research	Study Director

Locations

Not provided

ID	Term
D003233	Conjunctivitis, Allergic
D006967	Hypersensitivity

ID	Term
D003231	Conjunctivitis
D003229	Conjunctival Diseases
D005128	Eye Diseases
D006969	Hypersensitivity, Immediate
D007154	Immune System Diseases

ID	Term
D003990	Dibenzoxepins
D006575	Heterocyclic Compounds, 3-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds