A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01646151
First received: July 18, 2012
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

An observational study comparing changing from an IOP-lowering treatment to a bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Visits and treatment are per normal clinical practice.


Condition Intervention
Glaucoma, Open-Angle
Ocular Hypertension
Drug: Bimatoprost

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Intraocular Pressure (IOP) at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Baseline.

  • IOP at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12.


Secondary Outcome Measures:
  • Physician Evaluation of IOP Lowering in the Study Eye(s) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.

  • Patient Assessment of Tolerability on a 4-Point Scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.

  • Physician Assessment of Tolerability on a 4-Point Scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.

  • Physician Assessment of Patient Compliance Compared to Previous Therapy [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.

  • Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No.

  • Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No.


Enrollment: 2580
Study Start Date: May 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Bimatoprost
Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Drug: Bimatoprost
Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
Other Names:
  • LUMIGAN®
  • GANFORT®

  Eligibility

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

Subjects with POAG and OHT

Criteria

Inclusion Criteria:

  • Diagnosis of POAG or OHT
  • Previous use of IOP-lowering medication

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: NCT01646151

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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01646151     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/033
Study First Received: July 18, 2012
Results First Received: February 18, 2014
Last Updated: May 15, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Bimatoprost
Cloprostenol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2014