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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:
Information provided by (Responsible Party):
Eye Therapies, LLC
ClinicalTrials.gov Identifier:
NCT01687426
First received: September 5, 2012
Last updated: December 21, 2012
Last verified: December 2012
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Eye Therapies, LLC:

Primary Outcome Measures:
  • IOP [ Time Frame: 14 days ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687426

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

No publications provided

Responsible Party: Eye Therapies, LLC
ClinicalTrials.gov Identifier: NCT01687426     History of Changes
Other Study ID Numbers: 12-150-0001
Study First Received: September 5, 2012
Last Updated: December 21, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013