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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 June 2017 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT02247804
First received: September 22, 2014
Last updated: June 15, 2017
Last verified: June 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
Official Title: The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension

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
Actual Study Start Date: October 23, 2014
Estimated Study Completion Date: May 3, 2019
Estimated Primary Completion Date: November 29, 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.
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®

  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 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 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 Trial Registry Team 877-277-8566 IR-CTRegistration@Allergan.com

  Show 196 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Margot Goodkin 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: June 15, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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 June 28, 2017