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Purpose

This study will evaluate the efficacy and safety of bimatoprost SR in participants 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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Bimatoprost SR 15 μg 		Study Eye: bimatoprost sustained release (SR) 15 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 names:
    • AGN-192024
  • Drug: Active Comparator: Timolol 0.5%
    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: 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 names:
    • AGN-192024
  • Drug: Active Comparator: Timolol 0.5%
    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: 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% 		Study Eye and Non-Study Eye: 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.
  • Drug: Active Comparator: Timolol 0.5%
    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.

More Details

Status
Completed
Sponsor
Allergan

Study Contact

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.