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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01489670
Other study ID # MAF/AGN/OPH/GLA/032
Secondary ID
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

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


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 LumiganĀ® 0.01% treatment? Week 12 No
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