VisionPhase 4NCT02033200

Safety Study Looking at the Effects of Stendra on Vision

A Phase 4 study testing Stendra 200 mg in people with Vision, run by VIVUS LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Vision
What is being tested?: Stendra 200 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteUnited States
Study dates: Jan 2014to Jan 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Celerion Inc
Tempe, Arizona, 85283

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Vision
Being tested: Stendra 200 mg, Placebo
Keywords: vision, Stendra, avanafil, PDE5 inhibitor, visual acuity, intraocular pressure, pupillometry, color vision discrimination, healthy males

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stendra 200 mgDrug
Also called avanafil
PlaceboDrug

Study groups in NCT02033200
Study group	Role	What they receive
Active	Experimental	Stendra 200 mg Receives: Drug: Stendra 200 mg; Drug: Placebo
Placebo	Placebo comparator	placebo Receives: Drug: Stendra 200 mg; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 1 hour
Change From Baseline in Intraocular Pressure 1 Hour Post Dosing
Intraocular Pressure was measured using the Goldman applanation tonometry
Measured: 1 hour

Secondary outcomes (4)

Change From Baseline in Visual Acuity 24 Hours Post Dosing
Measured: 24 hours
Change From Baseline in Pupil Dilation 24 Hour Post Dosing
Measured: 24 hour
Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing
Measured: 24 hours
Change From Baseline in Intraocular Pressure 24 Hour Post Dosing
Intraocular pressure was measuring using the Goldman applanation tonometry
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Jan 2014

First posted10 Jan 2014 (estimated)
Study startJan 2014
Primary completionJan 2014
Study completionJan 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for VisionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02033200
Sponsor's protocol ID: TA-402
Status last verified: Mar 2015
First submitted: 8 Jan 2014
Last updated: 13 Mar 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Vision trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02033200
Acronym / sponsor ID: TA-402
Conditions: Vision
Keywords: vision, Stendra, avanafil, PDE5 inhibitor, visual acuity, intraocular pressure, pupillometry, color vision discrimination
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: VIVUS LLCIndustry (pharma, biotech, devices)
Study start: Jan 2014
Primary completion: Jan 2014 (actual)
Study completion: Jan 2014 (actual)
First posted: 10 Jan 2014 (estimated)
Results: Posted 13 Mar 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Active	Experimental	Drug: Stendra 200 mg, Drug: PlaceboStendra 200 mg
Placebo	Placebo comparator	Drug: Stendra 200 mg, Drug: Placeboplacebo

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Stendra 200 mgAlso: avanafil	Drug	Active, Placebo
Placebo	Drug	Active, Placebo

Primary outcome

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.
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.
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.
Change From Baseline in Intraocular Pressure 1 Hour Post Dosing
Time frame: 1 hour
Intraocular Pressure was measured using the Goldman applanation tonometry

4 secondary outcomes

Change From Baseline in Visual Acuity 24 Hours Post Dosing
Time frame: 24 hours
Change From Baseline in Pupil Dilation 24 Hour Post Dosing
Time frame: 24 hour
Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing
Time frame: 24 hours
Change From Baseline in Intraocular Pressure 24 Hour Post Dosing
Time frame: 24 hours

Results and safety

Results posted to the registry on 13 Mar 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active	40	40
Placebo	40	40

Primary outcome: Change From Baseline in Color Vision Discrimination 1 Hour Post Dosing

Time frame: 1 hour. Mean (Standard Deviation). Unit: total error score

Measure	Active n = 40	Placebo n = 40
Right eye	0.1 (1.98)	-0.4 (2.37)
Left eye	-0.2 (1.70)	-0.5 (1.99)

Active vs Placebo: LS mean difference: 0.076 (95% CI -0.592 to 0.744), p = 0.8216, ANCOVA
Active vs Placebo: LS means difference: 0.257 (95% CI -0.258 to 0.771), p = 0.324, ANCOVA

Primary outcome: Change From Baseline in Visual Acuity 1 Hour Post Dosing

Time frame: 1 hour. Mean (Standard Deviation). Unit: LogMar

Measure	Active n = 40	Placebo n = 40
Right Eye	-0.014 (0.0641)	-0.023 (0.0694)
Left Eye	-0.042 (0.0809)	-0.011 (0.0836)

Active vs Placebo: LS means difference: 0.004 (95% CI -0.024 to 0.031), p = 0.7864, ANCOVA
Active vs Placebo: LS Means difference: -0.022 (95% CI -0.056 to 0.012), p = 0.1953, ANCOVA

Primary outcome: Change From Baseline in Pupil Dilation 1 Hour Post Dosing

Time frame: 1 hour. Mean (Standard Deviation). Unit: millimeter

Measure	Active n = 40	Placebo n = 40
Right eye	-0.14 (0.280)	0.02 (0.270)
Left eye	-0.19 (0.264)	-0.10 (0.285)

Active vs Placebo: LS means difference: -0.160 (95% CI -0.280 to -0.039), p = 0.0101, ANCOVA
Active vs Placebo: LS means difference: -0.087 (95% CI -0.209 to 0.035), p = 0.1583, ANCOVA

Primary outcome: Change From Baseline in Intraocular Pressure 1 Hour Post Dosing

Time frame: 1 hour. Mean (Standard Deviation). Unit: mm Hg

Measure	Active n = 40	Placebo n = 40
Right eye	0.03 (1.761)	0.29 (1.609)
Left eye	0.36 (1.860)	-0.26 (1.335)

Active vs Placebo: LS means difference: -0.031 (95% CI -0.746 to 0.685), p = 0.9324, ANCOVA
Active vs Placebo: LS means difference: 0.751 (95% CI 0.057 to 1.44), p = 0.0343, ANCOVA

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active	0 of 40 (0%)	16 of 40 (40%)	Not reported
Placebo	0 of 40 (0%)	2 of 40 (5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Stendra 200 mg in people with Vision, run by VIVUS LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Color Vision Discrimination 1 Hour Post Dosing (time frame: 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02033200.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2015.