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Long Term Use Of Xalacom In Patients Glaucoma Or Ocular Hypertension
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01191008
First received: August 26, 2010
Last updated: April 17, 2017
Last verified: February 2017
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Purpose
The objective of this Investigation is to evaluate the safety and efficacy of long-term treatment with Xalacom in medical practice. Also, occurrence of unknown and known adverse drug reactions (ADRs) in subjects treated with Xalacom will be monitored during the survey period, and whether an additional treatment outcome investigation and/or a post-marketing clinical study is required in the future will be determined.
| Condition | Intervention |
|---|---|
| Glaucoma Ocular Hypertension | Drug: Latanoprost-timolol maleate fixed combination ophthalmic solution |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Special Investigation Of Long Term Use Of Xalacom(Regulatory Post Marketing Commitment Plan) |
Resource links provided by NLM:
Genetics Home Reference related topics:
early-onset glaucoma
MedlinePlus related topics:
Glaucoma
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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).
Other Outcome Measures:
- 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.
| Enrollment: | 661 |
| Study Start Date: | October 2010 |
| Study Completion Date: | May 2015 |
| Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 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
|
Detailed Description:
All the patients whom an investigator prescribes the first Xalacom® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
The patients whom an investigator involving A6641056 prescribes the Xalacom® Combination Eye Drops.
Criteria
Inclusion Criteria:
- Patients need to be administered Xalacom® in order to be enrolled in the surveillance.
Exclusion Criteria:
- Patients not administered Xalacom®.
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191008
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191008
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01191008 History of Changes |
| Other Study ID Numbers: |
A6641056 |
| Study First Received: | August 26, 2010 |
| Results First Received: | December 22, 2016 |
| Last Updated: | April 17, 2017 |
Keywords provided by Pfizer:
|
Xalacom Regulatory post marketing commitment plan safety |
Additional relevant MeSH terms:
|
Hypertension Glaucoma Ocular Hypertension Vascular Diseases Cardiovascular Diseases Eye Diseases Ophthalmic Solutions Timolol Latanoprost Maleic acid |
Pharmaceutical Solutions Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on September 21, 2017