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A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Switched to Lumigan® UD Monotherapy for Medical Reasons

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01853085
First received: May 10, 2013
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

The study will evaluate patients diagnosed with primary open angle glaucoma or ocular hypertension who are switched to Lumigan® UD monotherapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.


Condition Intervention Phase
Glaucoma, Primary Open Angle
Ocular Hypertension
Drug: Bimatoprost Ophthalmic Solution
Phase 4

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

Secondary Outcome Measures:
  • Physician Assessment of IOP-Lowering Effect on a 3-Point Scale [ 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 ]
  • Percentage of Patients who Discontinue Treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Patients Prescribed by the Physician to Continue Treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment: 1834
Study Start Date: April 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with POAG or OHT
Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
Drug: Bimatoprost Ophthalmic Solution
Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
Other Name: Lumigan® UD

  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:

  • Diagnosed with primary open-angle glaucoma or ocular hypertension
  • Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to Lumigan® UD for medical reasons

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: NCT01853085

Locations
Germany
Wiesloch, Baden-Württemberg, Germany
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01853085     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/038
Study First Received: May 10, 2013
Last Updated: May 2, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on November 20, 2014