A Study of Bimatoprost 0.01% in the Clinical Setting

Ocular Hypertension Clinical Trial

— APPEAL-Taiwan  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01814761
• Other study ID #: GMA-AP-EYE-AGN-001
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2013
• Last updated: September 28, 2015
• Start date: May 2013
• Est. completion date: August 2014

Study information

• Verified date: September 2015
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Center for Drug Evaluation
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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%

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Glaucoma, Primary Open Angle
• Ocular Hypertension

Intervention

Drug:
• Bimatoprost 0.01%
One drop of bimatoprost 0.01% (Lumigan® 0.01%) in the affected eye(s) every evening for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale	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.	12 Weeks	No
Secondary	Change From Baseline in Intraocular Pressure (IOP) in the Study Eye	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).	Baseline, Week 12	No
Secondary	Percentage of Patients Who Discontinue Due to an Adverse Event	An adverse event is any untoward medical occurrence associated with the use of a drug, whether or not considered drug related.	12 Weeks	No
Secondary	Overall Percent Change From Baseline in IOP	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).	Baseline, Week 12	No