Observational Study of Lumigan® 0.01% for Treatment of Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568008
• Other study ID #: MAF/AGN/OPH/GLA/031
• Status: Completed
• Phase: N/A
• First received: March 29, 2012
• Last updated: July 18, 2013
• Start date: October 2011
• Est. completion date: September 2012

Study information

• Verified date: July 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This is an observational study in patients with POAG or OHT that will collect data on the use of Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) in a routine clinical setting. Patients will be seen at baseline and at a follow-up visit approximately 8-12 weeks after baseline, as per normal clinical practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 933
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of POAG or OHT

• Prescribed Lumigan® 0.01%

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

Drug:
• Bimatoprost 0.01% ophthalmic solution
Bimatoprost 0.01% ophthalmic solution eye drops at a dose and frequency as determined by the physician.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure (IOP) at Baseline	IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eye at Baseline.	Baseline	No
Primary	Intraocular Pressure (IOP) at Week 12	IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left eye and the right eye at Week 12. The lower the IOP values the greater the improvement.	Week 12	No
Secondary	Patient Assessment of Treatment Tolerability Using a 4-Point Scale	Patients evaluated their tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported.	12 weeks	No
Secondary	Physician Assessment of Treatment Tolerability Using a 4-Point Scale	The Physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed in each of the categories is reported.	12 weeks	No
Secondary	Physician Reported Reasons for Treatment Discontinuation	The number of patients who discontinued from treatment by category is reported. More than one reason may apply to each patient.	12 weeks	No
Secondary	Number of Patients Continuing Treatment After 12 Weeks	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?	12 weeks	No