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A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension

NCT02636946 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2022-02-23

Study results available
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Summary

This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in participants with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).

Conditions

  • Glaucoma
  • Open-Angle Ocular Hypertension

Interventions

DRUG

Bimatoprost SR

Up to three Bimatoprost SR 15 micrograms (μg) administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR 15 μg administrations at Day 4 and Week 16 (Stage 2).

DRUG

Sham Bimatoprost SR

Up to three Sham Bimatoprost SR administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).

PROCEDURE

Selective Laser Trabeculoplasty

Selective Laser Trabeculoplasty administered on Day 1.

PROCEDURE

Sham Selective Laser Trabeculoplasty

Sham Selective Laser Trabeculoplasty administered on Day 1.

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
2016-02-24
Primary Completion
2021-01-26
Completion
2021-01-26
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Denmark
  • France
  • Poland
  • Russia
  • Singapore
  • Spain
  • Thailand

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 NCT02636946 on ClinicalTrials.gov