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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

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 sustained-release Other: Sham Drug: Timolol Drug: Timolol Vehicle (placebo) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 527 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 16, 2014
Actual Primary Completion Date : October 25, 2018
Actual Study Completion Date : May 7, 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 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.
 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.
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.
 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.
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.
 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®


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline in Intraocular Pressure (IOP) in the Study Eye [ Time Frame: Baseline, Week 12 ]
  2. IOP in the Study Eye [ Time Frame: Week 2 ]
  3. IOP in the Study Eye [ Time Frame: Week 6 ]
  4. IOP in the Study Eye [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Change from Baseline in IOP in the Study Eye [ Time Frame: Baseline, Week 2, Week 6 ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
More Information
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Additional Information:

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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
Last Update Posted: June 22, 2020
Last Verified: June 2020

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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