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CompletedNCT01687426Updated Dec 25, 2012

Study Evaluating the Safety and Intraocular Pressure (IOP) Lowering Response of Brimonidine Tartrate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension

A Phase 1 interventional study of Brimonidine Tartrate 0.025% and Vehicle in Glaucoma and Ocular Hypertension, sponsored by Eye Therapies, LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-12-25.

Sponsored by Eye Therapies, LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine the intraocular Pressure (IOP) lowering response and evaluate the safety of brimonidine tartrate 0.025% ophthalmic solution in adult subjects with open angle glaucoma or ocular hypertension.

02

Conditions studied

03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 15 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

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
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Be at least 18 years of age at Visit 1 (Screening), of either sex and any race
  • Be willing and able to provide written informed consent prior to any study procedures being performed.
  • Be willing and able to follow all instructions and attend all study visits.
  • Be willing to discontinue use of disallowed medication
  • Have a documented diagnosis of ocular hypertension, open angle glaucoma or chronic angle closure glaucoma with a patent iridotomy.

Exclusion criteria

Exclusion Criteria:

  • Have known sensitivity or poor tolerance to brimonidine or any other component of the study medications.
  • Have any form of glaucoma other than open-angle glaucoma, ocular hypertension or chronic angle closure glaucoma with patent iridotomy.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
15 participants (actual)

Study arms

  • Active comparator
    Brimonidine Tartrate 0.025%

    Drug: Brimonidine Tartrate 0.025% · Drug: Vehicle

  • Placebo comparator
    Vehicle

    Drug: Brimonidine Tartrate 0.025% · Drug: Vehicle

Interventions

  • DrugBrimonidine Tartrate 0.025%

    1 drop in each eye daily four times a day for 14 days

  • DrugVehicle

    1 drop in each eye daily four times a day for 14 days

06

What researchers measure

Primary outcomes

  1. IOP

    Time frame: 14 days

Other outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety

    Time frame: For up to 8 weeks

07

Study locations

1 site
  • Clinical Site
    Winchester, Massachusetts 01890, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 25, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01687426
Lead sponsor
Eye Therapies, LLC
Responsible party
Sponsor
First posted
Sep 19, 2012
Start date
Sep 2012
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Dec 25, 2012

Oversight

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

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This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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