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

This study is currently recruiting participants.
Verified January 2013 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01646151
First received: July 18, 2012
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  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:

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, 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IOP [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Patient Assessment of Tolerability on a 4-Point Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Physician Assessment of Tolerability on a 4-Point Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Physician Assessment of Patient Adherence with Treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients Who Discontinue Treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients Who Continue Treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients Who Reach Their Individual IOP Target [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 3500
Study Start Date: May 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Bimatoprost
Bimatoprost-containing eye drops administered at a dose determined by the physician in accordance with standard of care
 Drug: Bimatoprost
Bimatoprost-containing eye drops administered at a dose determined by the physician in accordance with standard of care
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646151

Contacts
Contact: Allergan Inc. clinicaltrials@allergan.com

Locations
Germany
Recruiting
Dresden, Germany
Netherlands
Recruiting
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
Last Updated: January 2, 2013
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 May 16, 2013