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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01814761
First Posted: March 20, 2013
Last Update Posted: October 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
March 18, 2013
March 20, 2013
September 28, 2015
October 26, 2015
October 26, 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 ]
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 ]
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 ]
    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 ]
    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 ]
    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 ]
  • Percentage of Patients Who Discontinue Due to an Adverse Event [ Time Frame: 12 Weeks ]
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%
Chen YY, Wang TH, Liu C, Wu KY, Chiu SL, Simonyi S, Lu DW. Tolerability and efficacy of bimatoprost 0.01 % in patients with open-angle glaucoma or ocular hypertension evaluated in the Taiwanese clinical setting: the Asia Pacific Patterns from Early Access of Lumigan 0.01 % (APPEAL Taiwan) study. BMC Ophthalmol. 2016 Sep 15;16(1):162. doi: 10.1186/s12886-016-0338-6.

*   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%
Sexes Eligible for Study: All
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