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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01687426
First Posted: September 19, 2012
Last Update Posted: December 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eye Therapies, LLC
  Purpose
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.

Condition Intervention Phase
Glaucoma and Ocular Hypertension Drug: Brimonidine Tartrate 0.025% Drug: Vehicle Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Eye Therapies, LLC:

Primary Outcome Measures:
  • IOP [ Time Frame: 14 days ]

Other Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: For up to 8 weeks ]

Enrollment: 15
Study Start Date: September 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Brimonidine Tartrate 0.025% Drug: Brimonidine Tartrate 0.025%
1 drop in each eye daily four times a day for 14 days
Drug: Vehicle
1 drop in each eye daily four times a day for 14 days
Placebo Comparator: Vehicle Drug: Brimonidine Tartrate 0.025%
1 drop in each eye daily four times a day for 14 days
Drug: Vehicle
1 drop in each eye daily four times a day for 14 days

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687426


Locations
United States, Massachusetts
Clinical Site
Winchester, Massachusetts, United States, 01890
Sponsors and Collaborators
Eye Therapies, LLC
  More Information

Responsible Party: Eye Therapies, LLC
ClinicalTrials.gov Identifier: NCT01687426     History of Changes
Other Study ID Numbers: 12-150-0001
First Submitted: September 5, 2012
First Posted: September 19, 2012
Last Update Posted: December 25, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Brimonidine Tartrate
Pharmaceutical Solutions
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs