Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489670
• Other study ID #: MAF/AGN/OPH/GLA/032
• Status: Completed
• Phase: N/A
• First received: December 1, 2011
• Last updated: February 13, 2014
• Start date: September 2011
• Est. completion date: March 2013

Study information

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

Clinical Trial Summary

This study will assess the efficacy, safety, tolerability and persistence of use of Lumigan ® 0.01% in patients diagnosed with primary open-angle glaucoma or ocular hypertension who are treated per routine clinical practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 387
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of primary open-angle glaucoma or ocular hypertension

• Lumigan® 0.01% prescribed either as monotherapy or adjunctive to beta-blocker therapy

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
Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

Switzerland, 

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 and right eye at the Final Visit at approximately Week 12. The lower the IOP values the greater the improvement.	Week 12	No
Secondary	Physician Evaluation of Efficacy Using a 5-Point Scale	The physician evaluated efficacy using a 5-point scale (IOP lower than the target, Target IOP reached, IOP decreased but target not reached, IOP increased or No change). The number of participants in each category is reported.	Week 12	No
Secondary	Patient Evaluation of Tolerability of Treatment 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 participants in each category is reported.	Week 12	No
Secondary	Physician Evaluation of Tolerability of Treatment	The physician evaluated the patient's tolerability of treatment using a 4-point scale (very good, good, moderate, and poor). The percentage of participants assessed in each category is reported.	Week 12	No
Secondary	Physician Reported Reasons for Early Discontinuation of Treatment	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?	Week 12	No