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A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01131104
Recruitment Status : Completed
First Posted : May 26, 2010
Results First Posted : April 5, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date May 10, 2010
First Posted Date May 26, 2010
Results First Submitted Date December 8, 2016
Results First Posted Date April 5, 2018
Last Update Posted Date April 5, 2018
Study Start Date May 2010
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 5, 2017)
30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use [ Time Frame: 30 days prior to NAION onset ]
Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION.
Original Primary Outcome Measures
 (submitted: May 25, 2010)
Number of patients with adjudicated NAION diagnosis and who are non-chronic users of PDE5 inhibitors. [ Time Frame: day 1 ]
Change History Complete list of historical versions of study NCT01131104 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors
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)
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Potential cases of acute NAION will be prospectively identified by approximately 20 neuro-ophthalmology centers in the US
Condition Nonarteritic Anterior Ischemic Optic Neuropathy
Intervention Drug: PDE5 Inhibitors
Observational study of participants who have been prescribed phosphodiesterase type 5 (PDE5) inhibitors by their physician during routine clinical practice.
Other Names:
  • tadalafil
  • sildenafil
  • vardenafil
Study Groups/Cohorts Cohort 1
Participants with NAION who have used PDE5 inhibitors
Intervention: Drug: PDE5 Inhibitors
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 5, 2017)
345
Original Estimated Enrollment
 (submitted: May 25, 2010)
125
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult male subjects, at least 18 years of age, who are willing to participate in the study
  • Participants who experienced abrupt visual loss in one eye (defined as typically less than a 1-day period or visual loss noted upon awakening) and presented for an initial visit within 45 days of onset of NAION symptoms to an ophthalmologist that resulted in a diagnosis of Suspected NAION by the investigator

Exclusion Criteria:

  • Previous history of NAION
  • Previous history of arteritis (anywhere in the body) or clinical or diagnostic testing evidence of temporal arteritis
  • History of glaucoma in either one or both eyes
  • History of multiple sclerosis or diagnostic testing evidence of optic neuritis
  • Have dementia or other reasons for memory impairment in the opinion of the investigator
  • Have participated in other non-observational studies within 3 months of NAION onset
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01131104
Other Study ID Numbers 11638
H6D-MC-LVHQ ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Eli Lilly and Company
Study Sponsor Eli Lilly and Company
Collaborators Not Provided
Investigators
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
PRS Account Eli Lilly and Company
Verification Date September 2017