Phase 4
Completed N=80
Safety Study Looking at the Effects of Stendra on Vision
Vision
Source: ClinicalTrials.gov NCT02033200 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcomePrimary: Change From Baseline in Color Vision Discrimination 1 Hour Post Dosing — 0.1; -0.4; -0.2; -0.5 total error score — p=0.8216
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Color Vision Discrimination 1 Hour Post Dosing |
0.1; -0.4; -0.2; -0.5 | 0.8216 |
| PRIMARY Change From Baseline in Visual Acuity 1 Hour Post Dosing |
-0.014; -0.023; -0.042; -0.011 | 0.7864 |
| PRIMARY Change From Baseline in Pupil Dilation 1 Hour Post Dosing |
-0.14; 0.02; -0.19; -0.10 | 0.0101 sig |
| PRIMARY Change From Baseline in Intraocular Pressure 1 Hour Post Dosing |
0.03; 0.29; 0.36; -0.26 | 0.9324 |
| SECONDARY Change From Baseline in Visual Acuity 24 Hours Post Dosing |
-0.012; -0.035; -0.027; -0.020 | 0.3139 |
| SECONDARY Change From Baseline in Pupil Dilation 24 Hour Post Dosing |
0.0; -0.02; -0.06; -0.07 | 0.7723 |
| SECONDARY Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing |
-0.1; -0.4; -0.2; -0.1 | 0.7787 |
| SECONDARY Change From Baseline in Intraocular Pressure 24 Hour Post Dosing |
-0.10; 0.03; 0.03; -0.09 | 0.8209 |
Eligibility Criteria
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 90 beats per minute (3 rechecks)
- Systolic blood pressure 140 mm Hg or Diastolic blood pressure 90 mm Hg (3 rechecks)
- Initiation or change in dose of any α-blockers 14 days prior to randomization
Data sourced from ClinicalTrials.gov (NCT02033200). 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. Informational only — not medical advice.