An Evaluation of the Onset and Duration of Action of AKF-... | NCT01561521

Studies
An Evaluation of the Onset and Duration of Action of AKF-1 Ophthalmic Solution in Treating Acute Allergic Conjunctivitis

NCT01561521

Sponsor

Akorn, Inc.

Status

Completed

Last Update Posted

Jul 18, 2013Estimated

Enrollment

90Actual

Phase

Phase 3

Conditions

Allergic Conjunctivitis

Interventions

AKF-1
AKF-1
AKF-1

Countries

United States

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

May 2012

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 2012

Primary Completion Date

Apr 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

Mar 21, 2012

First Submission Date that Met QC Criteria

Mar 22, 2012

First Posted Date

Mar 23, 2012Estimated

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 16, 2013

Certification/Extension First Submitted that Passed QC Review

Jul 16, 2013

Certification/Extension First Posted Date

Jul 18, 2013Estimated

Last Update Submitted Date

Jul 16, 2013

Last Update Posted Date

Jul 18, 2013Estimated

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 this study is to evaluate the onset and duration of action of two concentrations of AKF-1 Ophthalmic Solution compared to vehicle in the conjunctival allergen challenge (CAC) model of acute allergic conjunctivitis.

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

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
AKF-1 0.025%	Experimental	Drug: AKF-1
AKF-1 0.035%	Experimental	Drug: AKF-1
AKF-1 0%	Placebo Comparator	Drug: AKF-1

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AKF-1	Drug	1 drop AKF-1 0.025% in each eye at 2 separate times during a 14 day period	AKF-1 0.025%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ocular Itching at defined time points up to 2 weeks		Baseline to day 14
Ocular Redness at defined time points up to 2 weeks		Baseline to day 14

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

positive bilateral conjunctival allergen challenge (CAC) reaction

Exclusion Criteria:

known contraindications or sensitivities to the study medication or its components
any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters
use of disallowed medication during the period indicated prior to the enrollment or during the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Andover Eye Associates		Andover	Massachusetts	01810	United States

Condition Browse Module

MeSH Terms

ID	Term
D003233	Conjunctivitis, Allergic

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided