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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02033200
Other study ID # TA-402
Secondary ID
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


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
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