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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
  Purpose
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).

Condition Intervention Phase
Glaucoma, Primary Open Angle Ocular Hypertension Drug: Bimatoprost 0.01% Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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).


Enrollment: 312
Study Start Date: May 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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%).
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 (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%).
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%

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with primary open-angle glaucoma or ocular hypertension
Criteria

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%
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01814761


Locations
Taiwan
Taichung City, Taiwan
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01814761     History of Changes
Other Study ID Numbers: GMA-AP-EYE-AGN-001
First Submitted: March 18, 2013
First Posted: March 20, 2013
Results First Submitted: September 28, 2015
Results First Posted: October 26, 2015
Last Update Posted: October 26, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Ocular Hypertension
Glaucoma, Open-Angle
Eye Diseases
Glaucoma
Bimatoprost
Antihypertensive Agents