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
  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 ] [ 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.


Secondary Outcome Measures:
  • 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).


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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01814761

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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01814761     History of Changes
Other Study ID Numbers: GMA-AP-EYE-AGN-001 
Study First Received: March 18, 2013
Results First Received: September 28, 2015
Last Updated: September 28, 2015
Health Authority: Taiwan: Center for Drug Evaluation

Additional relevant MeSH terms:
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Glaucoma
Bimatoprost
Antihypertensive Agents
Cardiovascular Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on February 08, 2016