Study Evaluating the Safety and Efficacy of Brimonidine T... | NCT01675609

Studies
Study Evaluating the Safety and Efficacy of Brimonidine Tartrate Ophthalmic Solution in Adult and Geriatric Subjects

NCT01675609

Sponsor

Eye Therapies, LLC

Status

Completed

Last Update Posted

Jul 31, 2014Estimated

Enrollment

57Actual

Phase

Phase 2

Conditions

Ocular Redness

Interventions

Placebo
Brimonidine tartrate 0.025%

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

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

Aug 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Not provided

First Submitted Date

Aug 28, 2012

First Submission Date that Met QC Criteria

Aug 28, 2012

First Posted Date

Aug 30, 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 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 this study is to evaluate the safety and efficacy of brimonidine tartrate 0.025% ophthalmic solution used four times daily in a population of adult and geriatric subjects

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
Brimonidine Tartrate 0.025%	Experimental		Drug: Brimonidine tartrate 0.025%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	1 drop in each eye daily for up to 35 days	Placebo
Brimonidine tartrate 0.025%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ocular redness	redness evaluated by investigator prior to study medication instillation and redness evaluated by the subject as captured in dosing diary	at specified timepoints for up to 180 minutes

Secondary Outcomes

Measure	Description	Time Frame
Ocular Redness	evaluated prior to study medication instillation and at 5 minutes post instillation	up to 5 minutes post study medication instillation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Be at least 40 years of age
Must have normal ocular health
Must have history of redness relief drop use or desire to use

Exclusion Criteria:

Must not have any ocular/systemic health problems
Must agree to avoid disallowed medications

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ora, Inc.		Andover	Massachusetts	01810	United States