A Study of Lumigan® 0.01% in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01589510
• Other study ID #: MAF/AGN/OPH/GLA/034
• Status: Completed
• Phase: N/A
• First received: April 30, 2012
• Last updated: May 15, 2014
• Start date: April 2012
• Est. completion date: February 2013

Study information

• Verified date: May 2014
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Observational

Clinical Trial Summary

A study of Lumigan® 0.01% as administered in standard practice for patients with POAG or OHT. All treatment decisions, care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 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

Intervention

Drug:
• bimatoprost 0.01% ophthalmic solution
Bimatoprost 0.01% ophthalmic solution (Lumigan® 0.01%) as prescribed by physician per standard practice for up to 14 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Austria, 

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 eyes at Baseline.	Baseline	No
Primary	IOP at Week 14	IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 14.	Week 14	No
Secondary	Physician Evaluation of IOP Lowering in the Study Eye(s)	IOP is a measurement of the fluid pressure inside the eye. Physicians evaluated IOP compared to the target IOP for each patient's study eye(s). The numbers of eyes in each category are presented.	Week 14	No
Secondary	Patient Assessment of Tolerability on a 4-Point Scale	Patient assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.	Week 14	No
Secondary	Physician Assessment of Tolerability on a 4-Point Scale	Physician assessment of tolerability was assessed using a 4-point scale (very good, good, moderate, and poor). The numbers of patients in each category are presented.	Week 14	No
Secondary	Percentage of Patients Who Discontinue Lumigan® 0.01% Prior to 14 Weeks of Treatment	Patients who discontinued Lumigan® 0.01% prior to 14 weeks was assessed as Yes or No.	14 Weeks	No
Secondary	Percentage of Patients Who Continue Lumigan® 0.01% Treatment	Patients who will continue Lumigan® 0.01% after 14 weeks of treatment was assessed as Yes or No.	Week 14	No
Secondary	Physician Assessment of Patient Compliance Compared to Previous Therapy	Physician assessment of patient compliance compared to previous therapy was assessed on a 3-point scale (better, equal, and worse). The numbers of patients in each category are presented.	Week 14	No