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

NCT02250651 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 528

Last updated 2021-07-28

Study results available
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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.

Conditions

Interventions

DRUG

Bimatoprost SR

Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.

OTHER

Sham: Applicator Without Needle

Sham administered on Day 1, Week 16, and Week 32.

DRUG

Active Comparator: Timolol 0.5%

Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.

DRUG

Timolol Vehicle (placebo)

Timolol vehicle administered once in the morning and once in the evening for up to 20 months.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Margot Goodkin · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-15
Primary Completion
2018-10-25
Completion
2020-07-22
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • Colombia
  • Czechia
  • Egypt
  • Germany
  • Italy
  • Malaysia
  • New Zealand
  • Singapore
  • South Africa
  • South Korea
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02250651 on ClinicalTrials.gov