Safety Study Looking at the Effects of Stendra on Vision

Vision Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02033200
• Other study ID #: TA-402
• Status: Completed
• Phase: Phase 4
• First received: January 8, 2014
• Last updated: March 2, 2015
• Start date: January 2014
• Est. completion date: January 2014

Study information

• Verified date: March 2015
• Source: VIVUS, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 a-blockers 14 days prior to randomization

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vision

Intervention

Drug:
• Stendra 200 mg

• Placebo

Locations

Country	Name	City	State
United States	Celerion Inc	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
VIVUS, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 hour	Yes
Primary	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.	1 hour	Yes
Primary	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.	1 hour	Yes
Primary	Change From Baseline in Intraocular Pressure 1 Hour Post Dosing	Intraocular Pressure was measured using the Goldman applanation tonometry	1 hour	Yes
Secondary	Change From Baseline in Visual Acuity 24 Hours Post Dosing		24 hours	Yes
Secondary	Change From Baseline in Pupil Dilation 24 Hour Post Dosing		24 hour	Yes
Secondary	Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing		24 hours	Yes
Secondary	Change From Baseline in Intraocular Pressure 24 Hour Post Dosing	Intraocular pressure was measuring using the Goldman applanation tonometry	24 hours	Yes