Safety Study Looking at the Effects of Stendra on Vision

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Vision

Intervention / Treatment
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* Drug: Stendra 200 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Stendra 200 mg | Drug: Stendra 200 mg<br> <br> * Other names: avanafil;Drug: Placebo<br> <br> |
| Placebo Comparator: Placebo<br>placebo | Drug: Stendra 200 mg<br> <br> * Other names: avanafil;Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 hour | 
| 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. | 1 hour | 
| 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. | 1 hour | 
| Change From Baseline in Intraocular Pressure 1 Hour Post Dosing | Intraocular Pressure was measured using the Goldman applanation tonometry | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Intraocular pressure was measuring using the Goldman applanation tonometry | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vision, Stendra, avanafil, PDE5 inhibitor, visual acuity, intraocular pressure, pupillometry, color vision discrimination, healthy males