Safety Study Looking at the Effects of Stendra on Vision

March 2, 2015 updated by: VIVUS LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tempe, Arizona, United States, 85283
        • Celerion Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
placebo
Drug: Placebo
Drug: Stendra 200 mg
Other Names:
  • avanafil
EXPERIMENTAL: Active
Stendra 200 mg
Drug: Placebo
Drug: Stendra 200 mg
Other Names:
  • avanafil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour
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.
1 hour
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.
1 hour
Change From Baseline in Intraocular Pressure 1 Hour Post Dosing
Time Frame: 1 hour
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
Time Frame: 24 hours
24 hours
Change From Baseline in Pupil Dilation 24 Hour Post Dosing
Time Frame: 24 hour
24 hour
Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing
Time Frame: 24 hours
24 hours
Change From Baseline in Intraocular Pressure 24 Hour Post Dosing
Time Frame: 24 hours
Intraocular pressure was measuring using the Goldman applanation tonometry
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VIVUS LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

January 8, 2014

First Submitted That Met QC Criteria

January 9, 2014

First Posted (ESTIMATE)

January 10, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 13, 2015

Last Update Submitted That Met QC Criteria

March 2, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TA-402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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