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
  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:


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

ClinicalTrials.gov processed this record on October 19, 2014