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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

September 5, 2012
December 21, 2012
September 2012
December 2012   (final data collection date for primary outcome measure)
IOP [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01687426 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: For up to 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
 
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 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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Glaucoma and Ocular Hypertension
  • 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
  • Active Comparator: Brimonidine Tartrate 0.025%
    Interventions:
    • Drug: Brimonidine Tartrate 0.025%
    • Drug: Vehicle
  • Placebo Comparator: Vehicle
    Interventions:
    • Drug: Brimonidine Tartrate 0.025%
    • Drug: Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01687426
12-150-0001
No
Eye Therapies, LLC
Eye Therapies, LLC
Not Provided
Not Provided
Eye Therapies, LLC
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP