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

Overview

This study will evaluate the intraocular pressure-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication.

Full Title of Study: “A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 24, 2021

Interventions

  • Drug: Bimatoprost SR
    • Up to two Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).
  • Drug: Sham Bimatoprost SR
    • Up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).
  • Procedure: Selective Laser Trabeculoplasty
    • Selective Laser Trabeculoplasty administered on Day 1.
  • Procedure: Sham Selective Laser Trabeculoplasty
    • Sham Selective Laser Trabeculoplasty administered on Day 1.

Arms, Groups and Cohorts

  • Experimental: Bimatoprost Sustained-Release (SR)
    • Assigned Primary Eye: Sham Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to two Bimatoprost SR Administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). Contralateral Eye: SLT administered on Day 1 followed by up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).
  • Active Comparator: Selective Laser Trabeculoplasty (SLT)
    • Assigned Primary Eye: SLT administered on Day 1 followed by up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). Contralateral Eye: Sham Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to two Bimatoprost SR Administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).

Clinical Trial Outcome Measures

Primary Measures

  • Change from Baseline in IOP at Week 4
    • Time Frame: Baseline, Week 4
  • Change from Baseline in IOP at Week 12
    • Time Frame: Baseline, Week 12
  • Change from Baseline in Intraocular Pressure (IOP) at Week 24
    • Time Frame: Baseline, Week 24

Secondary Measures

  • IOP change from baseline at Week 8
    • Time Frame: Baseline, Week 8
  • IOP change from baseline at Week 15
    • Time Frame: Baseline, Week 15
  • IOP change from baseline at Week 20
    • Time Frame: Baseline, Week 20
  • Time to initial use of nonstudy IOP-lowering treatment as determined by the investigator
    • Time Frame: Baseline, Month 24
  • Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 4
    • Time Frame: Baseline, Week 4
  • Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 12
    • Time Frame: Baseline, Week 12
  • Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 24
    • Time Frame: Baseline, Week 24
  • Percentage of SLT eyes achieving ≥ 20% reduction at Week 4
    • Time Frame: Baseline, Week 4
  • Percentage of SLT eyes achieving ≥ 20% reduction at Week 12
    • Time Frame: Baseline, Week 12
  • Percentage of SLT eyes achieving ≥ 20% reduction at Week 24
    • Time Frame: Baseline, Week 24

Participating in This Clinical Trial

Inclusion Criteria

Inclusion Criteria:

  • Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that require IOP lowering treatment. Exclusion Criteria:

Exclusion Criteria:

  • Eye surgery (including cataract surgery) and or eye laser surgery within the past 6 months. – Previous use of commercially available Bimatoprost SR; concurrent enrollment in another Allergan Bimatoprost SR study; or previous enrollment in which an implant was received.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AbbVie
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • ABBVIE INC., Study Director, AbbVie

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