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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • 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 names:
    • 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 names:
    • TIMOPTIC┬«

Recruiting Locations

Montefiore Medical Center
The Bronx, New York 10467

More Details

NCT ID
NCT02247804
Status
Recruiting
Sponsor
Allergan

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.