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

This study is not yet open for participant recruitment.
Verified March 2013 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01814761
First received: March 18, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
  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:

Drug Information available for: Bimatoprost
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Patients With Ocular Hyperemia [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
Study Start Date: May 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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%).
 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01814761

Contacts
Contact: Allergan Inc. clinicaltrials@allergan.com

Locations
Taiwan
Not yet recruiting
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
Last Updated: March 18, 2013
Health Authority: Taiwan: Center for Drug Evaluation

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

ClinicalTrials.gov processed this record on May 16, 2013