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A Safety and Efficacy Study of Bimatoprost 0.01% in Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01594970
First received: May 8, 2012
Last updated: April 17, 2013
Last verified: April 2013
History of Changes
  Purpose

This study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular hypertension (OH).


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

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

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Number of Subjects with Ocular Hyperaemia [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in IOP [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
  • Percentage Change from Baseline in IOP [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from Baseline in IOP [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Enrollment: 800
Study Start Date: March 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bimatoprost 0.01%
1 drop in the affected eye(s), administered in the evening.
 Drug: Bimatoprost 0.01%
1 drop in the affected eye(s), administered in the evening.
Other Name: LUMIGAN® 0.01%

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elevated IOP due to either primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594970

Locations
Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01594970     History of Changes
Other Study ID Numbers: APMA-001211
Study First Received: May 8, 2012
Last Updated: April 17, 2013
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013