MyopiaNCT03024970

Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens

A study testing stenfilcon A lens with solution additive (test) in people with Myopia, run by CooperVision, Inc. at 2 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to investigate the overall clinical performance of the test daily disposable stenfilcon A lens with solution additive (test) compared to the stenfilcon A lens (control). Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: stenfilcon A lens with solution additive (test)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 2 sitesUnited States
Study dates: Jan 2017to 26 Jun 2017
Phase: Interventional
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

A person is eligible for inclusion in the study if he/she:
Has had a self-reported oculo-visual examination in the last two years.
Is at least 18 years of age and has full legal capacity to volunteer.
Has read and understood the information consent letter.
Is willing and able to follow instructions and maintain the appointment schedule.
Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.

Show all 12Show fewer

Must achieve 20/30 or better (in each eye) with study lenses
Requires spectacle lens powers between -0.75 and -6.50 diopters sphere (0.25D steps).
Has no more than 0.75 diopters of refractive astigmatism.
Currently wears soft contact lenses.
Have clear corneas and no active ocular disease.
Has not worn lenses for at least 12 hours before the examination

Who cannot join

A person will be excluded from the study if he/she:
Has never worn contact lenses before.
Has any systemic disease affecting ocular health.
Is using any systemic or topical medications that will affect ocular health.
Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.

Show all 11Show fewer

Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
Is aphakic.
Has undergone corneal refractive surgery.
Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
Have taken part in any other contact lens or care solution clinical trial or research, within one week prior to starting this study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Clinical Optical Research Lab (CORL)
Bloomington, Indiana, 47405
The Ocular Surface Institute (TOSI)
Houston, Texas, 77204

Other trials in United States

About this study

The purpose of this study is to investigate the overall clinical performance of the test daily disposable stenfilcon A lens with solution additive (test) compared to the stenfilcon A lens (control).

Read the detailed description

This will be, prospective, multicenter, double-masked, randomized, bilateral, 1 month cross-over, dispensing study comparing the test lens against the stenfilcon A control lens with a study duration of approximately two months.

Each subject will be randomized to wear either the test or control as a matched pair first and subjects will be randomized based on the order in which the subject is enrolled and qualified into the study.

Conditions: Myopia
Being tested: stenfilcon A lens with solution additive (test), stenfilcon A lens (control)
Medical subject headings: Myopia

What participants receive

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

stenfilcon A lens with solution additive (test)Device
silicone hydrogel lens
stenfilcon A lens (control)Device
contact lens

Study groups in NCT03024970
Study group	Role	What they receive
stenfilcon A lens with solution additive (test)	Experimental	Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study. Receives: Device: stenfilcon A lens with solution additive (test); Device: stenfilcon A lens (control)
stenfilcon A lens (control)	Active comparator	Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study. Receives: Device: stenfilcon A lens with solution additive (test); Device: stenfilcon A lens (control)

What is being measured

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

Subjective Ratings on Comfort
Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Measured: Baseline
Subjective Ratings on Comfort
Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Measured: 1 Week
Subjective Ratings on Comfort
Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Measured: 1 Month
Vision Satisfaction
Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Measured: Baseline
Vision Satisfaction
Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Measured: 1 week
Vision Satisfaction
Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Measured: 1 Month
Visual Acuity On High Illumination High Contrast
Visual acuity is assessed on high illumination high contrast logMAR charts for test and control lenses. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Measured: Baseline
Visual Acuity On High Illumination High Contrast
Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Measured: 1 Week
Visual Acuity On High Illumination High Contrast
Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Measured: 1 Month
Visual Acuity On Low Illumination High Contrast
Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Measured: Baseline
Visual Acuity On Low Illumination High Contrast
Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Measured: 1 Week
Visual Acuity On Low Illumination High Contrast
Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Measured: 1 Month
Overall Corneal Staining
Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.
Measured: One Week
Overall Corneal Staining
Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.
Measured: One Month
Conjunctival Staining
Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent
Measured: 1 Week
Conjunctival Staining
Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent
Measured: 1 Month
Bulbar Hyperemia
Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Measured: 1 Week
Bulbar Hyperemia
Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Measured: 1 Month
Limbal Hyperemia
Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Measured: 1 Week
Limbal Hyperemia
Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Measured: 1 Month
Palpebral Hyperemia
Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Measured: 1 Week
Palpebral Hyperemia
Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Measured: 1 Month

Secondary outcomes (14)

Lens Fit Acceptance
Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Measured: Baseline
Lens Fit Acceptance
Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Measured: 1 week
Lens Fit Acceptance
Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Measured: 1 Month
Handling Satisfaction
Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree
Measured: 1 week
Handling Satisfaction
Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree
Measured: 1 Month
Lens Surface - Wettability
Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
Measured: Baseline
Lens Surface - Wettability
Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
Measured: 1 Week
Lens Surface - Wettability
Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
Measured: 1 Month
Lens Surface - Deposits
Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
Measured: Baseline
Lens Surface - Deposits
Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
Measured: 1 week
Lens Surface - Deposits
Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
Measured: 1 Month
Subjective Ratings on Dryness
Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
Measured: Baseline
Subjective Ratings on Dryness
Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
Measured: 1 week
Subjective Ratings on Dryness
Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
Measured: 1 Month

Timeline

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

Jan 201726 Jun 2017

First posted19 Jan 2017 (estimated)
Study startJan 2017
Primary completion25 Apr 2017
Study completion26 Jun 2017

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 MyopiaStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03024970
Sponsor's protocol ID: CV-16-60
Status last verified: Jul 2020
First submitted: 17 Jan 2017
Last updated: 21 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: 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

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens
ClinicalTrials.gov ID: NCT03024970
Acronym / sponsor ID: CV-16-60
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2017
Primary completion: 25 Apr 2017 (actual)
Study completion: 26 Jun 2017 (actual)
First posted: 19 Jan 2017 (estimated)
Results: Posted 9 Jul 2020

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 investigate the overall clinical performance of the test daily disposable stenfilcon A lens with solution additive (test) compared to the stenfilcon A lens (control).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
stenfilcon A lens with solution additive (test)	Experimental	Device: stenfilcon A lens with solution additive (test), Device: stenfilcon A lens (control)Participants were randomized to wear the stenfilcon A lens with solution additive (test) for 1 month during the cross over study.
stenfilcon A lens (control)	Active comparator	Device: stenfilcon A lens with solution additive (test), Device: stenfilcon A lens (control)Participants were randomized to wear stenfilcon A (control) lens pair for 1 month during the cross over study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

A person is eligible for inclusion in the study if he/she:

Key exclusion criteria (11 listed)

A person will be excluded from the study if he/she:

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
stenfilcon A lens with solution additive (test)silicone hydrogel lens	Device	stenfilcon A lens (control), stenfilcon A lens with solution additive (test)
stenfilcon A lens (control)contact lens	Device	stenfilcon A lens (control), stenfilcon A lens with solution additive (test)

Primary outcome

Subjective Ratings on Comfort
Time frame: Baseline
Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Subjective Ratings on Comfort
Time frame: 1 Week
Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Subjective Ratings on Comfort
Time frame: 1 Month
Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Vision Satisfaction
Time frame: Baseline
Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Vision Satisfaction
Time frame: 1 week
Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Vision Satisfaction
Time frame: 1 Month
Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Visual Acuity On High Illumination High Contrast
Time frame: Baseline
Visual acuity is assessed on high illumination high contrast logMAR charts for test and control lenses. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Visual Acuity On High Illumination High Contrast
Time frame: 1 Week
Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Visual Acuity On High Illumination High Contrast
Time frame: 1 Month
Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Visual Acuity On Low Illumination High Contrast
Time frame: Baseline
Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Visual Acuity On Low Illumination High Contrast
Time frame: 1 Week
Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Visual Acuity On Low Illumination High Contrast
Time frame: 1 Month
Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Overall Corneal Staining
Time frame: One Week
Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.
Overall Corneal Staining
Time frame: One Month
Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.
Conjunctival Staining
Time frame: 1 Week
Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent
Conjunctival Staining
Time frame: 1 Month
Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent
Bulbar Hyperemia
Time frame: 1 Week
Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Bulbar Hyperemia
Time frame: 1 Month
Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Limbal Hyperemia
Time frame: 1 Week
Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Limbal Hyperemia
Time frame: 1 Month
Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Palpebral Hyperemia
Time frame: 1 Week
Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Palpebral Hyperemia
Time frame: 1 Month
Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)

14 secondary outcomes

Lens Fit Acceptance
Time frame: Baseline
Lens Fit Acceptance
Time frame: 1 week
Lens Fit Acceptance
Time frame: 1 Month
Handling Satisfaction
Time frame: 1 week
Handling Satisfaction
Time frame: 1 Month
Lens Surface - Wettability
Time frame: Baseline
Lens Surface - Wettability
Time frame: 1 Week
Lens Surface - Wettability
Time frame: 1 Month
Lens Surface - Deposits
Time frame: Baseline
Lens Surface - Deposits
Time frame: 1 week
Lens Surface - Deposits
Time frame: 1 Month
Subjective Ratings on Dryness
Time frame: Baseline
Subjective Ratings on Dryness
Time frame: 1 week
Subjective Ratings on Dryness
Time frame: 1 Month

Results and safety

Results posted to the registry on 9 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Lens Then Control Lens	34	33
Control Lens Then Test Lens	38	38

Primary outcome: Subjective Ratings on Comfort

Time frame: Baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Stenfilcon A Lens With Solution Additive (Test) n = 70	Stenfilcon A Lens (Control) n = 70
Value	9.7 (0.6)	9.6 (0.7)

Primary outcome: Subjective Ratings on Comfort

Time frame: 1 Week. Mean (Standard Deviation). Unit: units on a scale

Measure	Stenfilcon A Lens With Solution Additive (Test) n = 70	Stenfilcon A Lens (Control) n = 70
Value	9.1 (1.5)	9.0 (1.5)

Primary outcome: Subjective Ratings on Comfort

Time frame: 1 Month. Mean (Standard Deviation). Unit: units on a scale

Measure	Stenfilcon A Lens With Solution Additive (Test) n = 70	Stenfilcon A Lens (Control) n = 70
Value	8.9 (1.7)	8.6 (1.9)

Primary outcome: Vision Satisfaction

Time frame: Baseline. Number. Unit: percentage of participants

Measure	Stenfilcon A Lens With Solution Additive (Test) n = 70	Stenfilcon A Lens (Control) n = 70
Strongly disagree	0	0
Disagree	0	0
Neutral	6	1
Agree	39	39
Strongly agree	55	60

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline up to 1 month on each pair of lenses.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stenfilcon A Lens With Solution Additive (Test)	0 of 72 (0%)	1 of 72 (1.4%)	0 of 72
Stenfilcon A Lens (Control)	0 of 72 (0%)	5 of 72 (6.9%)	0 of 72

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

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.

Pete Kollbaum, OD, PhD principal investigator

Clinical Optics Research Lab (CORL) Indiana University School of Optometry.

Eric Ritchey, OD, PhD, FAAO principal investigator

University of Houston

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

Questions about this trial

What is this clinical trial studying?

A study testing stenfilcon A lens with solution additive (test) in people with Myopia, run by CooperVision, Inc. at 2 sites 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 12 inclusion and 11 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 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2020). 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?

Subjective Ratings on Comfort (time frame: Baseline). The study lists 22 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 NCT03024970.

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 21 Jul 2020.