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Efficacy and Safety 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
Results First Posted : July 28, 2021
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Ocular Hypertension Drug: Bimatoprost SR Other: Sham: Applicator Without Needle Drug: Active Comparator: Timolol 0.5% Drug: Timolol Vehicle (placebo) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 528 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension
Actual Study Start Date : December 15, 2014
Actual Primary Completion Date : October 25, 2018
Actual Study Completion Date : July 22, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bimatoprost SR 15 μg
Study Eye: bimatoprost sustained-release (SR) 15 micrograms (μg) administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); 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 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
 Drug: Bimatoprost SR
Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.

Other: Sham: Applicator Without Needle
Sham administered on Day 1, Week 16, and Week 32.

Drug: Active Comparator: Timolol 0.5%
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.

Drug: Timolol Vehicle (placebo)
Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
Experimental: Bimatoprost SR 10 μg
Study Eye: bimatoprost SR 10 μg administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); 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 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
 Drug: Bimatoprost SR
Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.

Other: Sham: Applicator Without Needle
Sham administered on Day 1, Week 16, and Week 32.

Drug: Active Comparator: Timolol 0.5%
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.

Drug: Timolol Vehicle (placebo)
Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
Active Comparator: Timolol 0.5%: Comparator
Both Eyes: sham administered on Day 1 (Period 1), Week 16 (Period 2), and Week 32 (Period 3); timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
 Other: Sham: Applicator Without Needle
Sham administered on Day 1, Week 16, and Week 32.

Drug: Active Comparator: Timolol 0.5%
Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Intraocular Pressure (IOP) in the Study Eye to Week 12 (Hours 0 and 2) [ Time Frame: Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Week 12 (Hours 0 and 2) ]
    IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. A mixed-effects model with repeated measures (MMRM) was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.

  2. IOP in the Study Eye at Week 2 (Hour 0) [ Time Frame: Week 2 (Hour 0) ]
    IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.

  3. IOP in the Study Eye at Week 2 (Hour 2) [ Time Frame: Week 2 (Hour 2) ]
    IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.

  4. IOP in the Study Eye at Week 6 (Hour 0) [ Time Frame: Week 6 (Hour 0) ]
    IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.

  5. IOP in the Study Eye at Week 6 (Hour 2) [ Time Frame: Week 6 (Hour 2) ]
    IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.

  6. IOP in the Study Eye at Week 12 (Hour 0) [ Time Frame: Week 12 (Hour 0) ]
    IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.

  7. IOP in the Study Eye at Week 12 (Hour 2) [ Time Frame: Week 12 (Hour 2) ]
    IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses.


Secondary Outcome Measures :
  1. Change From Baseline in IOP in the Study Eye [ Time Frame: Baseline (Up to 3 days prior to Day 1 at Hours 0 and 2) to Weeks 2 and 6 (Hours 0 and 2) ]
    IOP is a measurement of the fluid pressure inside the study eye. Measurements were taken at Hours 0 and 2. The study eye is defined as the eye that meets the entry criteria. If both eyes meet the entry criteria, the eye with the higher IOP at Baseline Hour 0 will be selected as the study eye. If both eyes had the same IOP at Hour 0, then the right eye was designated as the study eye. MMRM was used for analyses. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.


Eligibility Criteria
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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.


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

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
Contacts and Locations
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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): NCT02250651


Locations
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Sponsors and Collaborators
Allergan
Investigators
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Study Director: Margot Goodkin Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Study Protocol  [PDF] June 5, 2018
Statistical Analysis Plan  [PDF] October 29, 2018

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02250651    
Other Study ID Numbers: 192024-092
2014-003186-24 ( EudraCT Number )
First Posted: September 26, 2014    Key Record Dates
Results First Posted: July 28, 2021
Last Update Posted: July 28, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Bimatoprost
 Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents