NCT01675609

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

2 months

First QC Date

August 28, 2012

Last Update Submit

July 28, 2014

Conditions

Ocular Redness

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Ocular Redness

    up to 5 minutes post study medication instillation

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Brimonidine Tartrate 0.025%

EXPERIMENTAL
Drug: Brimonidine tartrate 0.025%

Interventions

PlaceboDRUG

1 drop in each eye daily for up to 35 days

Placebo
Brimonidine tartrate 0.025%DRUG

1 drop in each eye for up to 35 days

Brimonidine Tartrate 0.025%

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ora, Inc.

Andover, Massachusetts, 01810, United States

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2012

First Posted

August 30, 2012

Study Start

August 1, 2012

Primary Completion

October 1, 2012

Last Updated

July 31, 2014

Record last verified: 2014-07

Locations

US(1)