Safety Study Looking at the Effects of Stendra on Vision

Phase 4

Completed

• Conditions: Vision
• Interventions: Drug: Stendra 200 mg; Drug: Placebo

• Registration Number: NCT02033200
• Lead Sponsor: VIVUS LLC

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-10
• Status Verified: 2015-03
• Results First Submitted: 2015-03-02
• Results First Submitted QC: 2015-03-02
• Last Update Submitted: 2015-03-02
• Results First Posted: 2015-03-13
• Last Update Posted: 2015-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	Placebo	Stendra 200 mg
Placebo	Placebo	placebo
Active	Stendra 200 mg	Stendra 200 mg
Placebo	Stendra 200 mg	placebo

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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
Change From Baseline in Visual Acuity 24 Hours Post Dosing	24 hours
Change From Baseline in Pupil Dilation 24 Hour Post Dosing	24 hour

Trial Locations

Locations (1)

Celerion Inc; 🇺🇸 Tempe, Arizona, United States