Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01489670
First received: December 1, 2011
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

This study will assess the efficacy, safety, tolerability and persistence of use of Lumigan ® 0.01% in patients diagnosed with primary open-angle glaucoma or ocular hypertension who are treated per routine clinical practice.


Condition Intervention
Glaucoma, Open-Angle
Ocular Hypertension
Drug: bimatoprost 0.01% ophthalmic solution

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 eye at Baseline.

  • Intraocular Pressure (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 eye at the Final Visit at approximately Week 12. The lower the IOP values the greater the improvement.


Secondary Outcome Measures:
  • Physician Evaluation of Efficacy Using a 5-Point Scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The physician evaluated efficacy using a 5-point scale (IOP lower than the target, Target IOP reached, IOP decreased but target not reached, IOP increased or No change). The number of participants in each category is reported.

  • Patient Evaluation of Tolerability of Treatment Using a 4-Point Scale [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of participants in each category is reported.

  • Physician Evaluation of Tolerability of Treatment [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The percentage of participants assessed in each category is reported.

  • Physician Reported Reasons for Early Discontinuation of Treatment [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient.

  • Number of Patients Continuing Treatment After 12 Weeks [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The number of patients continuing treatment after 12 weeks was determined by the physician answering yes to the question: Is the patient continuing on Lumigan® 0.01% treatment?


Enrollment: 387
Study Start Date: September 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lumigan® 0.01%
Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
Drug: bimatoprost 0.01% ophthalmic solution
Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
Other Name: Lumigan® 0.01%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients diagnosed with primary open-angle glaucoma or ocular hypertension

Criteria

Inclusion Criteria:

  • Diagnosis of primary open-angle glaucoma or ocular hypertension
  • Lumigan® 0.01% prescribed either as monotherapy or adjunctive to beta-blocker therapy

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: NCT01489670

Locations
Switzerland
Bülach, Zurich, Switzerland
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01489670     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/032
Study First Received: December 1, 2011
Results First Received: February 13, 2014
Last Updated: February 13, 2014
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on August 20, 2014