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Trial record 47 of 154 for:    Brimonidine

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 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.
 
ClinicalTrials.gov Identifier: NCT01687426
Recruitment Status : Completed
First Posted : September 19, 2012
Last Update Posted : December 25, 2012
Sponsor:
Information provided by (Responsible Party):
Eye Therapies, LLC

Tracking Information
First Submitted Date  ICMJE September 5, 2012
First Posted Date  ICMJE September 19, 2012
Last Update Posted Date December 25, 2012
Study Start Date  ICMJE September 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
IOP [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01687426 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: September 18, 2012)
Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: For up to 8 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety and Intraocular Pressure (IOP) Lowering Response of Brimonidine Tartrate Ophthalmic Solution in Subjects With Open Angle Glaucoma or Ocular Hypertension
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Glaucoma and Ocular Hypertension
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2012)
15
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2012)
12
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01687426
Other Study ID Numbers  ICMJE 12-150-0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eye Therapies, LLC
Study Sponsor  ICMJE Eye Therapies, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Eye Therapies, LLC
Verification Date December 2012

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