Safety Study Looking at the Effects of Stendra on Vision
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 5/3/2014 |
| Start Date: | January 2014 |
| End Date: | February 2014 |
| Contact: | Walt Stutz |
| Phone: | 602-437-0097 |
A Double-Blind, Randomized, Placebo-Controlled, Single-Dose, Parallel Study to Assess the Effects of Avanafil (STENDRA™) on Multiple Parameters of Vision, Including, But Not Limited to Visual Acuity, Intraocular Pressure, Pupillometry, and Color Vision Discrimination, in Healthy Male Subjects
The purpose of this study is to see if Stendra causes any changes in vision, eye pressure,
pupil dilation, and color vision in healthy males.
pupil dilation, and color vision in healthy males.
The objectives of this study are to assess the effect of Stendra on visual acuity,
intraocular pressure, pupillometry, and color vision discrimination in healthy male
subjects.
intraocular pressure, pupillometry, and color vision discrimination in healthy male
subjects.
Inclusion Criteria:
- Healthy adult males 18 to 45 years of age, inclusive
- Non-tobacco user for at least 6 months prior to first dose
Exclusion Criteria:
- History or presence of retinal disease or any vision defects including color vision
- Intraocular pressure value ≥ 22mm Hg
- Resting heart rate < 45 or > 90 beats per minute (3 rechecks)
- Systolic blood pressure < 90 or > 140 mm Hg or Diastolic blood pressure < 50 or >90
mm Hg (3 rechecks)
- Initiation or change in dose of any α-blockers 14 days prior to randomization
We found this trial at
1
site
