Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension
|ClinicalTrials.gov Identifier: NCT01191008|
Recruitment Status : Completed
First Posted : August 30, 2010
Results First Posted : July 17, 2017
Last Update Posted : July 17, 2017
|Condition or disease||Intervention/treatment|
|Glaucoma Ocular Hypertension||Drug: Latanoprost-timolol maleate fixed combination ophthalmic solution|
|Study Type :||Observational|
|Actual Enrollment :||661 participants|
|Official Title:||Special Investigation Of Long Term Use Of Xalacom(Regulatory Post Marketing Commitment Plan)|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
|Latan-timolol maleate fixed comb ophthalmic solution||
Drug: Latanoprost-timolol maleate fixed combination ophthalmic solution
Xalacom® Combination Eye Drops depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "One drop should be applied to the affected eye(s) once daily".
Other Name: Xalacom
- Number of Participants WithTreatment-Related Adverse Events [ Time Frame: Max 104 weeks ]A treatment-related adverse event was any untoward medical occurrence attributed to latanoprost/timolol maleate in a participant who received latanoprost/timolol maleate. Relatedness to latanoprost/timolol maleate was assessed by the investigator.
- Clinical Effectiveness Rate [ Time Frame: Max 104 weeks ]Clinical effectiveness rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of effectiveness analysis population, was presented along with the corresponding exact 2sided 95% confidence interval. Overall effectiveness of latanoprost/timolol was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) not effective, or (3) not assessable at the end of observation period (Max 104 weeks).
- Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert [ Time Frame: Max 104 weeks ]A treatment-related adverse event was any untoward medical occurrence attributed to latanoprost/timolol maleate in a participant who received latanoprost/timolol maleate. Expectedness of the adverse event was determined according to Japanese package insert. Relatedness to latanoprost/timolol maleate was assessed by the investigator.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191008
|Study Director:||Pfizer CT.gov Call Center||Pfizer|