Safety Study Looking at the Effects of Stendra on Vision

Phase 4CompletedNCT02033200

VIVUS LLC80 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Vision

Interventions

Stendra 200 mgDRUG

PlaceboDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Celerion Inc

Tempe, Arizona, United States

Outcomes

Primary Outcomes

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

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

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

Change From Baseline in Intraocular Pressure 1 Hour Post Dosing

Intraocular Pressure was measured using the Goldman applanation tonometry

Time frame: 1 hour

Secondary Outcomes

Change From Baseline in Visual Acuity 24 Hours Post Dosing

Time frame: 24 hours

Change From Baseline in Pupil Dilation 24 Hour Post Dosing

Time frame: 24 hour

Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing

Time frame: 24 hours

Change From Baseline in Intraocular Pressure 24 Hour Post Dosing

Data from ClinicalTrials.gov

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