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Safety Study Looking at the Effects of Stendra on Vision

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ClinicalTrials.gov Identifier: NCT02033200
Recruitment Status : Completed
First Posted : January 10, 2014
Results First Posted : March 13, 2015
Last Update Posted : March 13, 2015
Sponsor:
Information provided by (Responsible Party):
VIVUS, Inc.

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.

Condition or disease Intervention/treatment Phase
Vision Drug: Stendra 200 mg Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2014
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Avanafil

Arm Intervention/treatment
Experimental: Active
Stendra 200 mg
Drug: Stendra 200 mg
Other Name: avanafil

Drug: Placebo
Placebo Comparator: Placebo
placebo
Drug: Stendra 200 mg
Other Name: avanafil

Drug: Placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033200


Locations
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United States, Arizona
Celerion Inc
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
VIVUS, Inc.

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Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT02033200     History of Changes
Other Study ID Numbers: TA-402
First Posted: January 10, 2014    Key Record Dates
Results First Posted: March 13, 2015
Last Update Posted: March 13, 2015
Last Verified: March 2015
Keywords provided by VIVUS, Inc.:
vision
Stendra
avanafil
PDE5 inhibitor
visual acuity
intraocular pressure
pupillometry
color vision discrimination
healthy males