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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT02247804
First received: September 22, 2014
Last updated: January 20, 2017
Last verified: January 2017
  Purpose
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 Intervention Phase
Glaucoma, Open-Angle
Ocular Hypertension
Drug: Bimatoprost sustained-release
Other: Sham
Drug: Timolol
Drug: Timolol Vehicle (placebo)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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 ]

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

Estimated Enrollment: 600
Study Start Date: October 2014
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 Allergan Study 192024-041D
  • 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 in either eye within the first 52 weeks of the study duration
  • History of glaucoma surgery
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02247804

Contacts
Contact: Clinical Trials Registry Team 1-800-347-4500 IR-CTRegistration@Allergan.com

  Show 196 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02247804     History of Changes
Other Study ID Numbers: 192024-091
2014-003037-26 ( EudraCT Number )
Study First Received: September 22, 2014
Last Updated: January 20, 2017

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Bimatoprost
Timolol
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on April 28, 2017