Skip to main content
OpenTrials
Completed

NCT Number: NCT01814761

A Study of Bimatoprost 0.01% in the Clinical Setting

This is a study of bimatoprost 0.01% (LUMIGAN® 0.01%) in subjects with primary open-angle glaucoma (POAG) or ocular hypertension (OH) who require further treatment for elevated intraocular pressure (IOP).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Taichung, Taiwan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of primary open-angle glaucoma or ocular hypertension
  • Determined by the treating physician to require treatment with bimatoprost 0.01%.

Exclusion criteria

  • Previous use of Lumigan® 0.01%

Treatment and study plan

Bimatoprost 0.01%

Drug

One drop of bimatoprost 0.01% (Lumigan® 0.01%) in the affected eye(s) every 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: 12 Weeks

    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 patients in each severity grade are presented.

Secondary outcomes

  1. Change From Baseline in Intraocular Pressure (IOP) in the Study Eye

    Time frame: Baseline, 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) and a positive number change from baseline indicates an increase in IOP (worsening).

  2. Percentage of Patients Who Discontinue Due to an Adverse Event

    Time frame: 12 Weeks

    An adverse event is any untoward medical occurrence associated with the use of a drug, whether or not considered drug related.

  3. Overall Percent Change From Baseline in IOP

    Time frame: Baseline, Week 12

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

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Acronym: APPEAL-Taiwan

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 20, 2013
Registry last updated
Oct 26, 2015

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.