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Completed

NCT Number: NCT02636946

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

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).

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Marsden Eye Specialists, Parramatta, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Eye surgery (including cataract surgery) and or eye laser surgery within the past 6 months.
  • Enrollment in other studies using Bimatoprost SR.

Treatment and study plan

Bimatoprost SR

Drug

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).

Sham Bimatoprost SR

Drug

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).

Selective Laser Trabeculoplasty

Procedure

Selective Laser Trabeculoplasty administered on Day 1.

Sham Selective Laser Trabeculoplasty

Procedure

Sham Selective Laser Trabeculoplasty administered on Day 1.

Primary outcomes

  1. Intraocular Pressure (IOP) at Baseline

    Time frame: Baseline (prior to treatment)

    IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0.

  2. Change From Baseline in IOP at Week 4

    Time frame: Baseline (prior to treatment) to Week 4

    IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A mixed-effects model with repeated measures (MMRM) was used for analyses.

  3. Change From Baseline in IOP at Week 12

    Time frame: Baseline (prior to treatment) to Week 12

    IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses.

  4. Change From Baseline in Intraocular Pressure (IOP) at Week 24

    Time frame: Baseline (prior to treatment) to Week 24

    IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening. A MMRM was used for analyses.

Secondary outcomes

  1. Change From Baseline in IOP at Weeks 8, 15, and 20

    Time frame: Baseline (prior to treatment) to Weeks 8, 15 and 20

    IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. A negative change from Baseline indicates an improvement and a positive change from Baseline indicates a worsening.

  2. Time to Initial Use of Nonstudy IOP-lowering Treatment as Determined by the Investigator

    Time frame: First treatment to end of study (up to 525 days)

    Median time in days from first treatment to the initial use of non-study IOP-lowering treatment.

  3. Percentage of Participants With Eyes Achieving a ≥ 20% Reduction in IOP

    Time frame: Baseline (prior to treatment) to Cycle 1: Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36, 40, 44, 47, 52; Cycle 2:Day 2, Weeks 4, 8, 12, 15, 20, 24, 28, 31, 36; Cycle 3: Day 2, Weeks 4, 8, 15, 20

    IOP is a measurement of the fluid pressure inside the eye. Measurements were taken at Hour 0. The participants who did not continue in the subsequent cycle were followed up to Week 52 in Cycle 1, Week 36 in Cycle 2, and Week 20 in Cycle 3.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Dec 22, 2015
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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