Skip to main content
OpenTrials
Completed

NCT Number: NCT01594970

A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)

This study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular hypertension (OH).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Ocular Hypertension

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elevated IOP due to either primary open-angle glaucoma or ocular hypertension

Exclusion criteria

  • None

Treatment and study plan

Bimatoprost 0.01%

Drug

1 drop in the affected eye(s), administered in the evening for 12 weeks.

Other names: LUMIGAN® 0.01%

Primary outcomes

  1. Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale

    Time frame: Week 12

    Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia is graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). The numbers of participants in each severity grade are presented.

Secondary outcomes

  1. Change From Baseline in Intraocular Pressure (IOP)

    Time frame: Baseline, Week 6, Week 12

    IOP is a measure of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement).

  2. Overall Percent Change From Baseline in IOP

    Time frame: Baseline, Week 6, Week 12

    IOP is a measure of the fluid pressure inside the eye. A negative number change response indicates a reduction in IOP (improvement).

Other outcomes

  1. Change From Baseline in Hyperemia Severity in the Study Eye

    Time frame: Baseline, Week 12

    Hyperemia is the engorgement of the blood vessels (redness) of the eye. Hyperemia was graded in the study eye on a 5 point scale where 0=None (Normal), 0.5=Trace (Trace reddish pink with no more than slight perilimbal injection), 1=Mild (Mild flush reddish color), 2=Moderate (Bright red color), and 3=Severe (Deep, bright, diffuse redness). 'Lower' categories refer to grades 0, 0.5 and 1, and 'higher' categories refer to grades 2 and 3. Change in hyperemia severity was classified as improved, no change or worsened based on the change in the hyperemia grading category from higher to lower, no change in category or lower to higher, respectively. The numbers of participants in each category are presented.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 9, 2012
Registry last updated
Jan 28, 2014

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.