A Study of Bimatoprost 0.01% in the Clinical Setting (APPEAL-Taiwan)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01814761
First received: March 18, 2013
Last updated: September 28, 2015
Last verified: September 2015

March 18, 2013
September 28, 2015
May 2013
August 2014   (final data collection date for primary outcome measure)
Severity of Ocular Hyperemia in the Study Eye on a 5-Point Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
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.
Percentage of Patients With Ocular Hyperemia [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01814761 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Intraocular Pressure (IOP) in the Study Eye [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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).
  • Percentage of Patients Who Discontinue Due to an Adverse Event [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    An adverse event is any untoward medical occurrence associated with the use of a drug, whether or not considered drug related.
  • Overall Percent Change From Baseline in IOP [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    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).
  • Change from Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients Who Discontinue Due to an Adverse Event [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Bimatoprost 0.01% in the Clinical Setting
Not Provided
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).
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Subjects with primary open-angle glaucoma or ocular hypertension
  • Glaucoma, Primary Open Angle
  • Ocular Hypertension
Drug: Bimatoprost 0.01%
One drop of bimatoprost 0.01% (Lumigan® 0.01%) in the affected eye(s) every evening for 12 weeks.
Other Name: Lumigan® 0.01%
  • Pts with POAG or OH (Previously Treatment Naive)
    Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
    Intervention: Drug: Bimatoprost 0.01%
  • Pts with POAG or OH (Switched Monotherapy)
    Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
    Intervention: Drug: Bimatoprost 0.01%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
312
August 2014
August 2014   (final data collection date for primary outcome measure)

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%
Both
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01814761
GMA-AP-EYE-AGN-001
No
Not Provided
Not Provided
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP