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 12, 2015
Last verified: May 2015
  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:
  • Intraocular Pressure (IOP) in the Study Eye at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the study eye.

  • IOP in the Study Eye at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the study eye.


Secondary Outcome Measures:
  • Physician Assessment of IOP-Lowering Effect in the Study Eye on a 3-Point Scale [ Time Frame: Baseline, 12 Weeks ] [ Designated as safety issue: No ]
    IOP is a measurement of the fluid pressure inside the eye. Physicians evaluate IOP change from baseline in the study eye as better than expected, as expected, and worse than expected. The numbers of patients in each category are presented.

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

  • Number of Patients Who Discontinue Treatment With Lumigan® UD Prior to 12 Weeks of Treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Patient discontinuation of treatment with Lumigan® UD prior to 12 weeks of treatment is assessed as Yes or No.

  • Number of Patients Who Continue Treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    Patient continuation of treatment with Lumigan® UD after the end of study participation is assessed as Yes or No.

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


Enrollment: 1830
Study Start Date: April 2013
Study Completion Date: March 2014
Primary Completion Date: March 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
Results First Received: May 12, 2015
Last Updated: May 12, 2015
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
Antihypertensive Agents
Cardiovascular Agents
Contraceptive Agents
Contraceptive Agents, Female
Luteolytic Agents
Pharmaceutical Solutions
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015