Vision
Conditions
Keywords
vision, Stendra, avanafil, PDE5 inhibitor, visual acuity, intraocular pressure, pupillometry, color vision discrimination, healthy males
Brief 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.
Detailed description
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.
Interventions
DRUGStendra 200 mg
DRUGPlacebo
Sponsors
VIVUS LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Intraocular Pressure 1 Hour Post Dosing | 1 hour | Intraocular Pressure was measured using the Goldman applanation tonometry |
| Change From Baseline in Color Vision Discrimination 1 Hour Post Dosing | 1 hour | Color vision discrimination was performed using the Lanthony 40-Hue Test according to Farnsworth-Munsell 100-Hue Test. The total error score was derived by counting the number of caps misplaced. |
| Change From Baseline in Visual Acuity 1 Hour Post Dosing | 1 hour | Visual acuity was measured using the Logarithm of the Minimum Angle Resolution (LogMAR) chart. The LogMAR value of the best line read was noted and the number of letters read in the next row was multiplied by 0.02, then subtracted from the LogMAR value of the best line completely read. |
| Change From Baseline in Pupil Dilation 1 Hour Post Dosing | 1 hour | Pupil dilation was measured using the Neuroptics Model VIP 200 pupillometer under standard lighting conditions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Visual Acuity 24 Hours Post Dosing | 24 hours | — |
| Change From Baseline in Pupil Dilation 24 Hour Post Dosing | 24 hour | — |
| Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing | 24 hours | — |
| Change From Baseline in Intraocular Pressure 24 Hour Post Dosing | 24 hours | Intraocular pressure was measuring using the Goldman applanation tonometry |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Stendra 200 mg | 40 |
| Placebo placebo | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Active | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 34.9 years STANDARD_DEVIATION 7.67 | 35.0 years STANDARD_DEVIATION 7.62 | 35.1 years STANDARD_DEVIATION 7.67 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 32 Participants | 66 Participants | 34 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 14 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 33 Participants | 68 Participants | 35 Participants |
| Region of Enrollment United States | 40 participants | 80 participants | 40 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 40 Participants | 80 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 40 | 2 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Change From Baseline in Color Vision Discrimination 1 Hour Post Dosing
Color vision discrimination was performed using the Lanthony 40-Hue Test according to Farnsworth-Munsell 100-Hue Test. The total error score was derived by counting the number of caps misplaced.
Time frame: 1 hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Change From Baseline in Color Vision Discrimination 1 Hour Post Dosing | Right eye | 0.1 total error score | Standard Deviation 1.98 |
| Active | Change From Baseline in Color Vision Discrimination 1 Hour Post Dosing | Left eye | -0.2 total error score | Standard Deviation 1.7 |
| Placebo | Change From Baseline in Color Vision Discrimination 1 Hour Post Dosing | Right eye | -0.4 total error score | Standard Deviation 2.37 |
| Placebo | Change From Baseline in Color Vision Discrimination 1 Hour Post Dosing | Left eye | -0.5 total error score | Standard Deviation 1.99 |
Comparison: The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.p-value: 0.821695% CI: [-0.592, 0.744]ANCOVA
Comparison: The sample size had adequate power to detect a meaningful difference between treatment groups in the left eye.p-value: 0.32495% CI: [-0.258, 0.771]ANCOVA
Primary
Change From Baseline in Intraocular Pressure 1 Hour Post Dosing
Intraocular Pressure was measured using the Goldman applanation tonometry
Time frame: 1 hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Change From Baseline in Intraocular Pressure 1 Hour Post Dosing | Right eye | 0.03 mm Hg | Standard Deviation 1.761 |
| Active | Change From Baseline in Intraocular Pressure 1 Hour Post Dosing | Left eye | 0.36 mm Hg | Standard Deviation 1.86 |
| Placebo | Change From Baseline in Intraocular Pressure 1 Hour Post Dosing | Right eye | 0.29 mm Hg | Standard Deviation 1.609 |
| Placebo | Change From Baseline in Intraocular Pressure 1 Hour Post Dosing | Left eye | -0.26 mm Hg | Standard Deviation 1.335 |
Comparison: The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in Intraocular Pressure between the two treatment groups in the right eye.p-value: 0.932495% CI: [-0.746, 0.685]ANCOVA
Comparison: The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in intraocular pressure between the two treatment groups in the left eye.p-value: 0.034395% CI: [0.057, 1.44]ANCOVA
Primary
Change From Baseline in Pupil Dilation 1 Hour Post Dosing
Pupil dilation was measured using the Neuroptics Model VIP 200 pupillometer under standard lighting conditions.
Time frame: 1 hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Change From Baseline in Pupil Dilation 1 Hour Post Dosing | Right eye | -0.14 millimeter | Standard Deviation 0.28 |
| Active | Change From Baseline in Pupil Dilation 1 Hour Post Dosing | Left eye | -0.19 millimeter | Standard Deviation 0.264 |
| Placebo | Change From Baseline in Pupil Dilation 1 Hour Post Dosing | Right eye | 0.02 millimeter | Standard Deviation 0.27 |
| Placebo | Change From Baseline in Pupil Dilation 1 Hour Post Dosing | Left eye | -0.10 millimeter | Standard Deviation 0.285 |
Comparison: The sample size provided enough power to detect any meaningful difference between the two treatment groups in the right eye.p-value: 0.010195% CI: [-0.28, -0.039]ANCOVA
Comparison: The sample size provided enough power to detect any meaningful difference between the two treatment groups in the left eye.p-value: 0.158395% CI: [-0.209, 0.035]ANCOVA
Primary
Change From Baseline in Visual Acuity 1 Hour Post Dosing
Visual acuity was measured using the Logarithm of the Minimum Angle Resolution (LogMAR) chart. The LogMAR value of the best line read was noted and the number of letters read in the next row was multiplied by 0.02, then subtracted from the LogMAR value of the best line completely read.
Time frame: 1 hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Change From Baseline in Visual Acuity 1 Hour Post Dosing | Right Eye | -0.014 LogMar | Standard Deviation 0.0641 |
| Active | Change From Baseline in Visual Acuity 1 Hour Post Dosing | Left Eye | -0.042 LogMar | Standard Deviation 0.0809 |
| Placebo | Change From Baseline in Visual Acuity 1 Hour Post Dosing | Right Eye | -0.023 LogMar | Standard Deviation 0.0694 |
| Placebo | Change From Baseline in Visual Acuity 1 Hour Post Dosing | Left Eye | -0.011 LogMar | Standard Deviation 0.0836 |
Comparison: The sample size provided enough power to detect any meaningful difference between the two treatment groups in the right eye.p-value: 0.786495% CI: [-0.024, 0.031]ANCOVA
Comparison: The sample size provided enough power to detect any meaningful difference between the two treatment groups in the left eye.p-value: 0.195395% CI: [-0.056, 0.012]ANCOVA
Secondary
Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing | Right eye | -0.1 total error score | Standard Deviation 1.66 |
| Active | Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing | Left eye | -0.2 total error score | Standard Deviation 1.69 |
| Placebo | Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing | Right eye | -0.4 total error score | Standard Deviation 2.49 |
| Placebo | Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing | Left eye | -0.1 total error score | Standard Deviation 2.14 |
Comparison: The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.p-value: 0.778795% CI: [-0.632, 0.475]ANCOVA
Comparison: The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.p-value: 0.601395% CI: [-0.865, 0.504]ANCOVA
Secondary
Change From Baseline in Intraocular Pressure 24 Hour Post Dosing
Intraocular pressure was measuring using the Goldman applanation tonometry
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Change From Baseline in Intraocular Pressure 24 Hour Post Dosing | Right eye | -0.10 mm Hg | Standard Deviation 2.176 |
| Active | Change From Baseline in Intraocular Pressure 24 Hour Post Dosing | Left eye | 0.03 mm Hg | Standard Deviation 1.694 |
| Placebo | Change From Baseline in Intraocular Pressure 24 Hour Post Dosing | Right eye | 0.03 mm Hg | Standard Deviation 1.423 |
| Placebo | Change From Baseline in Intraocular Pressure 24 Hour Post Dosing | Left eye | -0.09 mm Hg | Standard Deviation 1.339 |
Comparison: The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in IOP between the two treatment groups in the right eye.p-value: 0.820995% CI: [-0.705, 0.887]ANCOVA
Comparison: The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in IOP between the two treatment groups in the left eye.p-value: 0.493195% CI: [-0.43, 0.884]ANCOVA
Secondary
Change From Baseline in Pupil Dilation 24 Hour Post Dosing
Time frame: 24 hour
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Change From Baseline in Pupil Dilation 24 Hour Post Dosing | Right eye | 0.0 mm | Standard Deviation 0.238 |
| Active | Change From Baseline in Pupil Dilation 24 Hour Post Dosing | Left eye | -0.06 mm | Standard Deviation 0.223 |
| Placebo | Change From Baseline in Pupil Dilation 24 Hour Post Dosing | Right eye | -0.02 mm | Standard Deviation 0.249 |
| Placebo | Change From Baseline in Pupil Dilation 24 Hour Post Dosing | Left eye | -0.07 mm | Standard Deviation 0.289 |
Comparison: The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.p-value: 0.772395% CI: [-0.093, 0.125]ANCOVA
Comparison: The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.p-value: 0.910795% CI: [-0.109, 0.122]ANCOVA
Secondary
Change From Baseline in Visual Acuity 24 Hours Post Dosing
Time frame: 24 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Change From Baseline in Visual Acuity 24 Hours Post Dosing | Right eye | -0.012 LogMar | Standard Deviation 0.0682 |
| Active | Change From Baseline in Visual Acuity 24 Hours Post Dosing | Left eye | -0.027 LogMar | Standard Deviation 0.1042 |
| Placebo | Change From Baseline in Visual Acuity 24 Hours Post Dosing | Right eye | -0.035 LogMar | Standard Deviation 0.092 |
| Placebo | Change From Baseline in Visual Acuity 24 Hours Post Dosing | Left eye | -0.020 LogMar | Standard Deviation 0.0908 |
Comparison: The sample size had enough power to detect any meaningful difference between treatment groups in the right eye.p-value: 0.313995% CI: [-0.017, 0.051]ANCOVA
Comparison: The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.p-value: 0.933495% CI: [-0.045, 0.042]ANCOVA