Status:
COMPLETED
A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Optic Neuropathy, Ischemic
Eligibility:
MALE
45+ years
Brief Summary
The objective of this non-interventional study is to examine whether use of Phosphodiesterase Inhibitors (PDE5s), including use of sildenafil, vardenafil, or tadalafil, triggers the onset of acute NAI...
Detailed Description
Sites will identify patients who meet the entry criteria during the conduct of their normal practice. Patients meeting these criteria will be offered participation in the study after reading and compl...
Eligibility Criteria
Inclusion
- Male aged ≥45 years;
- Experienced abrupt visual change in only 1 eye
Exclusion
- Pain determined by an ophthalmologist to be consistent with an inflammatory/arteritic process or optic neuritis;
- History of NAION or optic neuritis.
- Participation in other studies within 60 days prior to entry in the study.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
673 Patients enrolled
Trial Details
Trial ID
NCT00759174
Start Date
November 1 2008
End Date
October 1 2012
Last Update
February 1 2021
Active Locations (105)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
2
Pfizer Investigational Site
Mobile, Alabama, United States, 36606
3
Pfizer Investigational Site
Anchorage, Alaska, United States, 99501
4
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205-7199