A Study Comparing IOP-Lowering Treatments to Bimatoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01646151
• Other study ID #: MAF/AGN/OPH/GLA/033
• Status: Completed
• Phase: N/A
• First received: July 18, 2012
• Last updated: May 15, 2014
• Start date: May 2012
• Est. completion date: April 2013

Study information

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

Clinical Trial Summary

An observational study comparing changing from an IOP-lowering treatment to a bimatoprost-containing IOP treatment in primary open-angle glaucoma (POAG) or ocular hypertension (OHT). Visits and treatment are per normal clinical practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2580
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of POAG or OHT

• Previous use of IOP-lowering medication

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Drug:
• Bimatoprost
Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

Germany,  Netherlands, 

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 12	IOP is a measurement of the fluid pressure inside the eye. IOP was measured in the left and right eyes at Week 12.	Week 12	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 12	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 12	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 12	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 12	No
Secondary	Percentage of Patients Who Discontinue Treatment With Bimatoprost-Containing Eye Drops Prior to 12 Weeks of Treatment	Patients who discontinue treatment with bimatoprost-containing eye drops prior to 12 weeks of treatment was assessed as Yes or No.	12 Weeks	No
Secondary	Percentage of Patients Who Continue Treatment With Bimatoprost-Containing Eye Drops	Patients who will continue treatment with bimatoprost-containing eye drops after 12 weeks of treatment was assessed as Yes or No.	Week 12	No