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OpenTrials
Completed

NCT Number: NCT02033200

Safety Study Looking at the Effects of Stendra on Vision

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.

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Key information

Conditions

Vision

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Celerion Inc

Tempe, Arizona, 85283, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stendra 200 mg

Drug

Other names: avanafil

Placebo

Drug

Primary outcomes

  1. Change From Baseline in Color Vision Discrimination 1 Hour Post Dosing

    Time frame: 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.

  2. Change From Baseline in Visual Acuity 1 Hour Post Dosing

    Time frame: 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.

  3. Change From Baseline in Pupil Dilation 1 Hour Post Dosing

    Time frame: 1 hour

    Pupil dilation was measured using the Neuroptics Model VIP 200 pupillometer under standard lighting conditions.

  4. Change From Baseline in Intraocular Pressure 1 Hour Post Dosing

    Time frame: 1 hour

    Intraocular Pressure was measured using the Goldman applanation tonometry

Secondary outcomes

  1. Change From Baseline in Visual Acuity 24 Hours Post Dosing

    Time frame: 24 hours

  2. Change From Baseline in Pupil Dilation 24 Hour Post Dosing

    Time frame: 24 hour

  3. Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing

    Time frame: 24 hours

  4. Change From Baseline in Intraocular Pressure 24 Hour Post Dosing

    Time frame: 24 hours

    Intraocular pressure was measuring using the Goldman applanation tonometry

Sponsors and collaborators

Lead sponsor

VIVUS LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 10, 2014
Registry last updated
Mar 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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