Safety Study Looking at the Effects of Stendra on Vision

Vivus

Status and phase: Completed; Phase 4

Conditions: Vision

Treatments: Drug: Placebo; Drug: Stendra 200 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02033200

TA-402

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

Stendra 200 mg

Treatment:

Drug: Stendra 200 mg

Drug: Placebo

Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Stendra 200 mg

Drug: Placebo