A Study to Determine if There is a Possible Association Between Nonarteritic Anterior Ischemic Optic Neuropathy (NAION) and Phosphodiesterase Type 5 (PDE5) Inhibitors
Study H6D-MC-LVHQ is an observational, non-interventional, multi-center, prospective, case-crossover study to evaluate the possible association between the use of phosphodiesterase type 5 (PDE5) inhibitors and the risk of acute nonarteritic anterior ischemic optic neuropathy (NAION) in males. Subjects with newly diagnosed NAION will be asked via a structured questionnaire about their use of PDE5 inhibitors and other risk factors prior to the onset of their vision loss.
|Study Design:||Observational Model: Case-Crossover
Time Perspective: Prospective
|Official Title:||A Prospective Case-crossover Study to Evaluate the Possible Association Between the Use of PDE5 Inhibitors and the Risk of Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)|
- Number of patients with adjudicated NAION diagnosis and who are non-chronic users of PDE5 inhibitors. [ Time Frame: day 1 ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Patients with NAION who have used PDE5 inhibitors
Drug: PDE5 Inhibitors
Observational study of participants who have been prescribed phosphodiesterase type 5 (PDE5) inhibitors by their physician during routine clinical practice.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131104
|Contact: There may be multiple sites in this observational study 1-877-CTLILLY (1-877-285-4559)||317-615-4559|
Show 44 Study Locations
|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fr- 9 AM-5 PM Eastern time (UTC?GMT - 5 hours, EST)||Eli Lilly and Company|