Safety Study Looking at the Effects of Stendra on Vision

NCT02033200 | Completed Phase 4 Results

• 1 other identifier: TA-402
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Vision

Keywords

vision; Stendra; avanafil; PDE5 inhibitor; visual acuity; intraocular pressure; pupillometry; color vision discrimination; healthy males

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Change From Baseline in Intraocular Pressure 1 Hour Post Dosing

  Intraocular Pressure was measured using the Goldman applanation tonometry

  1 hour

Secondary Outcomes (4)

• Change From Baseline in Visual Acuity 24 Hours Post Dosing

  24 hours

• Change From Baseline in Pupil Dilation 24 Hour Post Dosing

  24 hour

• Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing

  24 hours

• Change From Baseline in Intraocular Pressure 24 Hour Post Dosing

  24 hours

Study Arms (2)

Active

EXPERIMENTAL

Stendra 200 mg

Drug: Stendra 200 mg; Drug: Placebo

Placebo

PLACEBO COMPARATOR

placebo

Drug: Stendra 200 mg; Drug: Placebo

Interventions

Stendra 200 mg DRUG

Also known as: avanafil

Active; Placebo

Placebo DRUG

Active; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult males 18 to 45 years of age, inclusive
• Non-tobacco user for at least 6 months prior to first dose

You may not qualify if:

• 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

Sponsors & Collaborators

• VIVUS LLC: lead

Study Sites (1)

Celerion Inc

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

avanafil

Results Point of Contact

• Title: VP of Development
• Organization: Vivus Inc

650-934-5200

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 10, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 13, 2015
• Results First Posted: March 13, 2015

Record last verified: 2015-03

Locations

US (1)