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Lumigan® in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

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ClinicalTrials.gov Identifier: NCT01628588
Recruitment Status : Completed
First Posted : June 27, 2012
Results First Posted : September 24, 2012
Last Update Posted : September 24, 2012
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This is an observational study of Lumigan® 0.01% (bimatoprost) treatment in clinical practice for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).

Condition or disease Intervention/treatment
Glaucoma, Open-Angle Ocular Hypertension Drug: bimatoprost 0.01%

Study Type : Observational
Actual Enrollment : 854 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : March 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bimatoprost
U.S. FDA Resources

Group/Cohort Intervention/treatment
POAG or OHT
Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
Drug: bimatoprost 0.01%
Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry



Primary Outcome Measures :
  1. Change From Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, 14 Weeks ]
    IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.


Secondary Outcome Measures :
  1. Patient Assessment of Tolerability Using a 4-Point Scale [ Time Frame: 14 Weeks ]
    Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.

  2. Physician Assessment of Tolerability Using a 4-Point Scale [ Time Frame: 14 Weeks ]
    Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported.

  3. Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks [ Time Frame: 14 Weeks ]
    Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No.

  4. Patients Who Will Continue Use of Lumigan® After 14 Weeks [ Time Frame: 14 Weeks ]
    Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary open angle glaucoma or ocular hypertension
Criteria

Inclusion Criteria:

  • Diagnosis of primary open angle glaucoma or ocular hypertension
  • Prescribed Lumigan®

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628588


Locations
Netherlands
Amsterdam, Netherlands
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01628588     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/GLA/026
First Posted: June 27, 2012    Key Record Dates
Results First Posted: September 24, 2012
Last Update Posted: September 24, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Glaucoma, Open-Angle
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Bimatoprost
Antihypertensive Agents