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OpenTrials
Completed

NCT Number: NCT01687426

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

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.

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Key information

Conditions

Glaucoma and Ocular Hypertension Eye Diseases Glaucoma Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Site

Winchester, Massachusetts, 01890, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Brimonidine Tartrate 0.025%

Drug

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

Vehicle

Drug

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

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

Sponsors and collaborators

Lead sponsor

Eye Therapies, LLC

Industry

Registry information

Official study title

A Single-Center, Randomized, Double-Masked, Cross-Over Pilot Study Evaluating Safety and IOP Lowering Response of Brimonidine Tartrate Ophthalmic Solution Versus Vehicle in Subjects With Open Angle Glaucoma or Ocular Hypertension

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 19, 2012
Registry last updated
Dec 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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