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Completed

NCT Number: NCT04285580

A Phase 3b Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle Glaucoma or Ocular Hypertension

This study will evaluate the 24-hour intraocular pressure lowering effect and safety after a single administration of Bimatoprost SR in patients with Open-Angle Glaucoma or Ocular Hypertension

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Key information

Conditions

Open-angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Trinity Research Group /ID# 232749, Dothan, Alabama, United States

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 OAG or OHT study eye, requiring IOP-lowering treatment
  • Participant is currently a nonsmoker and has not smoked any nicotine-containing products within the previous 6 months

Exclusion criteria

  • Current or anticipated enrollment in another investigational drug or device study
  • Females who are pregnant, nursing, or planning a pregnancy during the study

Treatment and study plan

Bimatoprost SR

Drug

Consists of 1 Bimatoprost SR administration in the study eye.

LUMIGAN

Drug

Treatment with LUMIGAN 0.01% begins on Day 1. The drop will be instilled once daily in the evening to the study eye throughout the duration of the study.

Primary outcomes

  1. Change From Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR Treated Eyes

    Time frame: 8 weeks

    IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.

  2. Number of Patients Experiencing One or More Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 12 Months

    The number of patients who experienced one or more TEAEs

Secondary outcomes

  1. Change From Baseline in Range of Intraocular Pressure (IOP) for Bimatoprost SR-treated Eyes

    Time frame: 8 Weeks

    IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening. The range of IOP is calculated as maximum value minus minimum value per participant for each corresponding period with the smaller values showing less fluctuation of IOP.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

An Evaluation of the 24-Hour Intraocular Pressure(IOP)-Lowering Effect of Bimatoprost Sustained-Release(SR) in Participants With Open-Angle Glaucoma(OAG) or Ocular Hypertension(OHT)

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 26, 2020
Registry last updated
Jun 8, 2023

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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