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CompletedNCT01675609Updated Jul 31, 2014

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

A Phase 2 interventional study of Placebo and Brimonidine tartrate 0.025% in Ocular Redness, sponsored by Eye Therapies, LLC. Completed at 1 site in United States. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-31.

Sponsored by Eye Therapies, LLC · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Ocular Redness

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03

In context

Erythema

133 studies on the registry are indexed under Erythema; 11 are open to participants now.

This study's enrollment of 57 is close to the median of 59 across 110 interventional studies indexed under Erythema.

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Lead sponsor

Eye Therapies, LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Must not have any ocular/systemic health problems
  • Must agree to avoid disallowed medications
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
57 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    Brimonidine Tartrate 0.025%

    Drug: Brimonidine tartrate 0.025%

Interventions

  • DrugPlacebo

    1 drop in each eye daily for up to 35 days

  • DrugBrimonidine tartrate 0.025%

    1 drop in each eye for up to 35 days

06

What researchers measure

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

    Time frame: at specified timepoints for up to 180 minutes

Secondary outcomes

  1. Ocular Redness

    evaluated prior to study medication instillation and at 5 minutes post instillation

    Time frame: up to 5 minutes post study medication instillation

07

Study locations

1 site
  • Ora, Inc.
    Andover, Massachusetts 01810, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01675609
Lead sponsor
Eye Therapies, LLC
Responsible party
Sponsor
First posted
Aug 30, 2012
Start date
Aug 2012
Primary completion
Oct 2012
Last update
Jul 31, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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