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: September 30, 2015
Last verified: September 2015
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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:
- The incidence of adverse drug reactions. [ Time Frame: Max 104 weeks ] [ Designated as safety issue: Yes ]
- Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: Max 104 weeks ] [ Designated as safety issue: Yes ]
- Efficacy rate for the patients of glaucoma or ocular hypertension. [ Time Frame: Max 104 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 661 |
| Study Start Date: | October 2010 |
| Study Completion Date: | April 2014 |
| Primary Completion Date: | April 2014 (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 |
| Genders Eligible for Study: | Both |
| 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®.
Contacts and Locations
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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 |
| Last Updated: | September 30, 2015 |
| Health Authority: | United States: Food and Drug Administration |
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 Maleic acid Latanoprost Timolol |
Pharmaceutical Solutions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Physiological Effects of Drugs Anti-Arrhythmia Agents |
ClinicalTrials.gov processed this record on September 27, 2016