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Safety and Efficacy of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT02250651
Recruitment Status : Completed
First Posted : September 26, 2014
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE September 23, 2014
First Posted Date  ICMJE September 26, 2014
Last Update Posted Date June 22, 2020
Actual Study Start Date  ICMJE December 16, 2014
Actual Primary Completion Date October 25, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2014)
  • Change from Baseline in Intraocular Pressure (IOP) in the Study Eye [ Time Frame: Baseline, Week 12 ]
  • IOP in the Study Eye [ Time Frame: Week 2 ]
  • IOP in the Study Eye [ Time Frame: Week 6 ]
  • IOP in the Study Eye [ Time Frame: Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2014)
Change from Baseline in IOP in the Study Eye [ Time Frame: Baseline, Week 2, Week 6 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official Title  ICMJE The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension
Brief Summary This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in patients with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma, Open-Angle
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: Bimatoprost sustained-release
    Bimatoprost sustained-release (SR) administered in the study eye on Day 1, Week 16, and Week 32.
  • Other: Sham
    Sham administered on Day 1, Week 16, and Week 32, as per protocol.
  • Drug: Timolol
    Timolol administered once in the morning and once in the evening for up to 20 months, as per protocol.
    Other Name: TIMOPTIC®
  • Drug: Timolol Vehicle (placebo)
    Timolol vehicle administered once in the morning and once in the evening for up to 20 months, as per protocol.
Study Arms  ICMJE
  • Experimental: Bimatoprost SR Dose A
    Study Eye: bimatoprost sustained-release (SR) Dose A administered on Day 1, Week 16, and Week 32; timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1, Week 16, and Week 32; timolol administered once in the morning and once in the evening for up to 20 months.
    Interventions:
    • Drug: Bimatoprost sustained-release
    • Other: Sham
    • Drug: Timolol
    • Drug: Timolol Vehicle (placebo)
  • Experimental: Bimatoprost SR Dose B
    Study Eye: bimatoprost SR Dose B administered on Day 1, Week 16, and Week 32; timolol vehicle administered once in the morning and once in the evening for up to 20 months. Non-Study Eye: sham administration on Day 1, Week 16, and Week 32; timolol administered once in the morning and once in the evening for up to 20 months.
    Interventions:
    • Drug: Bimatoprost sustained-release
    • Other: Sham
    • Drug: Timolol
    • Drug: Timolol Vehicle (placebo)
  • Sham Comparator: Sham
    Both Eyes: sham administered on Day 1, Week 16, and Week 32; timolol administered once in the morning and once in the evening for up to 20 months.
    Interventions:
    • Other: Sham
    • Drug: Timolol
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 18, 2018)
527
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2014)
600
Actual Study Completion Date  ICMJE May 7, 2020
Actual Primary Completion Date October 25, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require IOP-lowering treatment.

Exclusion Criteria:

  • Previous enrollment in another Allergan Bimatoprost SR Study
  • Eye surgery (including cataract surgery) and/or any eye laser surgery within the past 6 months in the study eye
  • Anticipated need for laser eye surgery within the first 52 weeks of the study duration
  • History of glaucoma surgery
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 Argentina,   Canada,   Colombia,   Czechia,   Egypt,   Germany,   Italy,   Korea, Republic of,   Malaysia,   New Zealand,   Singapore,   South Africa,   Turkey,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Netherlands,   Portugal,   Saudi Arabia,   Thailand
 
Administrative Information
NCT Number  ICMJE NCT02250651
Other Study ID Numbers  ICMJE 192024-092
2014-003186-24 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Margot Goodkin Allergan
PRS Account Allergan
Verification Date June 2020

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