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Lumigan® in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01628588
First received: June 25, 2012
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
  Purpose

This is an observational study of Lumigan® 0.01% (bimatoprost) treatment in clinical practice for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).


Condition Intervention
Glaucoma, Open-Angle
Ocular Hypertension
 Drug: bimatoprost 0.01%

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:
  • Change From Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, 14 Weeks ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.


Secondary Outcome Measures:
  • Patient Assessment of Tolerability Using a 4-Point Scale [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
    Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.

  • Physician Assessment of Tolerability Using a 4-Point Scale [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
    Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.

  • Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
    Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No.

  • Patients Who Will Continue Use of Lumigan® After 14 Weeks [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
    Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No.


Enrollment: 854
Study Start Date: March 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
POAG or OHT
Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
 Drug: bimatoprost 0.01%
Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with primary open angle glaucoma or ocular hypertension

Criteria

Inclusion Criteria:

  • Diagnosis of primary open angle glaucoma or ocular hypertension
  • Prescribed Lumigan®

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628588

Locations
Netherlands
Amsterdam, Netherlands
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01628588     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/026
Study First Received: June 25, 2012
Results First Received: August 21, 2012
Last Updated: August 21, 2012
Health Authority: Netherlands: Ministry of Health, Welfare and Sport

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 16, 2013