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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01814761
First received: March 18, 2013
Last updated: June 25, 2014
Last verified: June 2014

March 18, 2013
June 25, 2014
May 2013
August 2014   (final data collection date for primary outcome measure)
Percentage of Patients With Ocular Hyperemia [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01814761 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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
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%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
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
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01814761
GMA-AP-EYE-AGN-001
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
June 2014

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