N/A
N=673
A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION
Optic Neuropathy, Ischemic
Bottom Line
View on ClinicalTrials.gov: NCT00759174 ↗Enrolled (actual)
673
Serious AEs
0.3%
Results posted
Oct 2013
Primary outcome: Primary: Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite NAION Cases — 14; 248 exposed days — p=0.033
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No intervention (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Male
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Days Exposed to PDE5i During 1-Day Case Window and 29 1-Day Control Windows Among Participants Adjudicated as Definite NAION Cases |
14; 248 | 0.033 sig |
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 NAION.
Eligibility Criteria
Inclusion Criteria
- Male aged ≥45 years;
- Experienced abrupt visual change in only 1 eye
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00759174). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.