Lumigan® 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: NCT01628588
• Other study ID #: MAF/AGN/OPH/GLA/026
• Status: Completed
• Phase: N/A
• First received: June 25, 2012
• Last updated: August 21, 2012
• Start date: March 2010
• Est. completion date: December 2010

Study information

• Verified date: August 2012
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Ministry of Health, Welfare and Sport
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 854
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diagnosis of primary open angle glaucoma or ocular hypertension

• Prescribed Lumigan®

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Intraocular Pressure (IOP)	IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.	Baseline, 14 Weeks	No
Secondary	Patient Assessment of Tolerability Using a 4-Point Scale	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.	14 Weeks	No
Secondary	Physician Assessment of Tolerability Using a 4-Point Scale	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.	14 Weeks	No
Secondary	Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks	Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No.	14 Weeks	No
Secondary	Patients Who Will Continue Use of Lumigan® After 14 Weeks	Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No.	14 Weeks	No