MyopiaNCT02642991

Dispensing Study for a New Study Lens

A study testing Phenacite and comfilcon A in people with Myopia, run by CooperVision, Inc. at 3 sites in 2 countries.

Completed

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

Trial summary

This study investigated the performance criteria over one week of daily wear to determine if the comfilcon A asphere lens (test) performed equivalently to the comfilcon A sphere (control) in terms of measurement and subjective ratings of visual performance. Read more about this study

Who is it for?: Ages 18 to 35 years
Conditions the study is for: Myopia
What is being tested?: Phenacite and comfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 3 sitesin 2 countries
Study dates: Nov 2015to Mar 2016
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 to 35 years
All sexes
No healthy volunteers
Adult

Who may be able to join

A person is eligible for inclusion in the study if he/she:
Oculo-visual examination in the last two years
Between 18 and 35 years of age and has full legal capacity to volunteer
Has read and understood the informed consent letter
Is willing and able to follow instructions and maintain the appointment schedule
Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected

Show all 12Show fewer

Currently wears, or has previously successfully worn, soft contact lenses between -1.00D (Diopoter) and -4.00D
Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder <-0.75
Has not worn lenses for at least 12 hours before the initial visit
Has a subjective response at baseline, which indicates suitability for this study
Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period
Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week

Who cannot join

A person will be excluded from the study if he/she:
Has never worn contact lenses before
Any systemic disease affecting ocular health
Is using any systemic or topical medications that will affect ocular health
Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.
Has any ocular pathology or anomaly that would affect the wearing of the lenses

Show all 14Show fewer

Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
Is aphakic
Has anisometropia of >1.00
Has undergone corneal refractive surgery
Has strabismus
Has any ocular amblyopia >= 1line of HC (High Contrast) Visual Acuity
Is participating in any other type of eye related clinical or research study
Has previously participated in study of the Phenacite lenses

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

United States2 sites

University of California
Berkeley, California, 94720
CORL, Indiana University
Bloomington, Indiana, 47405

Other trials in United States

Canada1 site

Center for Contact Lens Research, University of Waterloo
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

Official title: Dispensing Study for The Phenacite Project

Read the detailed description

This study was a prospective, single site, daily wear, double masked, randomized bilateral cross over dispensing study of binocular wear of comfilcon A asphere lens (test) and comfilcon A sphere lens (control) over 1 week of daily wear.

Conditions: Myopia
Being tested: Phenacite, comfilcon A
Medical subject headings: Myopia

What participants receive

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

PhenaciteDevice
contact lens
comfilcon ADevice
contact lens

Study groups in NCT02642991
Study group	Role	What they receive
Phenacite Test lens then comfilcon A control lens	Experimental	Participants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week. Receives: Device: Phenacite; Device: comfilcon A
Comfilcon A control lens then Phenacite test Lens	Active comparator	Participants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week. Receives: Device: Phenacite; Device: comfilcon A

What is being measured

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

Distance Visual Acuity (VA) - High Illumination
Distance visual acuity High Illumination was assessed using logMAR
Measured: Baseline (after 10 minutes of lens dispense)
Distance Visual Acuity (VA) - High Illumination
Distance visual acuity High Illumination was assessed using logMAR
Measured: 1 week
Near Visual Acuity (VA) - High Illumination
Near Visual Acuity (VA) - High Illumination assessed using logMAR
Measured: Baseline (after 10 minutes of lens dispense)
Near Visual Acuity (VA) - High Illumination
Near Visual Acuity (VA) - High Illumination assessed using logMAR
Measured: 1 week
Distance Visual Acuity (VA) - Low Illumination
Distance Visual Acuity (VA) - Low Illumination assessed using logMAR
Measured: Baseline (after 10 minutes of lens dispense)
Distance Visual Acuity (VA) - Low Illumination
Distance Visual Acuity (VA) - Low Illumination assessed using logMAR
Measured: 1 week
Near Visual Acuity (VA) - Low Illumination
Near Visual Acuity (VA) - Low illumination assessed using logMAR
Measured: Baseline (after 10 minutes of lens dispense)
Near Visual Acuity (VA) - Low Illumination
Near Visual Acuity (VA) - Low illumination assessed using logMAR
Measured: 1 week
Quality of Distance Vision
Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Measured: Baseline (after 10 minutes of lens dispense)
Quality of Distance Vision
Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Measured: 1 week
Quality of Near Vision
Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time
Measured: Baseline (After 10 minutes of lens dispense)
Quality of Near Vision
Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time
Measured: 1 week
Quality of Vision With Digital Device Use
Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Measured: Baseline (After 10 minutes of lens dispense)
Quality of Vision With Digital Device Use
Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Measured: 1 week
Quality of Intermediate Vision
Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Measured: Baseline (After 10 minutes of lens dispense)
Quality of Intermediate Vision
Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Measured: 1 week
Overall Vision Quality
Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Measured: Baseline (After 10 minutes of lens dispense)
Overall Vision Quality
Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Measured: 1 week

Secondary outcomes (21)

Biomicroscopy Findings - Bulbar Hyperemia
Bulbar hyperemia assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)
Measured: 1 week
Biomicroscopy Findings- Limbal Hyperemia
Investigator assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)
Measured: 1 week
Biomicroscopy Findings - Corneal Staining Extent
Investigator Assessment on Biomicroscopy Findings - Corneal Staining Extent on a scale of 0-4 : 0=No staining, 1=1-15% of area, 2=16-30% of area, 3=31-45% of area, 4= >45% of area
Measured: 1 week
Ghosting - Distance Vision
Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable
Measured: 1 week
Ghosting - Near Vision
Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable
Measured: 1 week
Overall Comfort
Patient subjective scoring using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.
Measured: Baseline (After 10 minutes of lens dispense)
Overall Comfort
Patient subjective scoring for overall comfort using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.
Measured: 1 week
Overall Dryness
Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.
Measured: Baseline (after 10 minutes of lens dispense)
Overall Dryness
Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.
Measured: 1 week
Lens Preference - Overall Vision Preference
Subjective rating of lens preference for overall vision preference (Phenacite, comfilcon A, No preference)
Measured: 1 week
Subjective Ratings of Change in Frequency of Tiredness
Subjective rating of change in eye fatigue frequency of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Measured: 1 week
Subjective Ratings of Change in Severity of Tiredness
Subjective rating of change in eye fatigue severity of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Measured: 1 week
Subjective Ratings of Change in Bothersome Rating for Tiredness
Subjective rating of change in eye fatigue bothersome rating for tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Measured: 1 week
Subjective Ratings of Change in Frequency of Dryness
Subjective rating of change in eye fatigue frequency of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Measured: 1 week
Subjective Ratings of Change in Severity of Dryness
Subjective rating of change in eye fatigue severity of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Measured: 1 week
Subjective Ratings of Change in Bothersome Rating of Dryness
Subjective rating of change in eye fatigue bothersome rating for dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Measured: 1 week
Subjective Questionnaire Response - Eye Strain
Subjective questionnaire response for " My eyes don't feel strained while wearing these lenses" - Agree, Disagree
Measured: 1 week
Subjective Questionnaire Response - Eye Feel Good
Subjective questionnaire response for " These lenses make my eyes feel good" - Agree, Disagree
Measured: 1 week
Subjective Questionnaire Response - Eye Feel Relaxed
Subjective questionnaire response for " These lenses make my eyes feel relaxed" - Agree, Disagree
Measured: 1 week
Subjective Questionnaire Response - Vision
Subjective questionnaire response for " These lenses help my vision" - Agree, Disagree
Measured: 1 week
Subjective Questionnaire Response - Eye Tired
Subjective questionnaire response for " These lenses make my eyes feel less tired" - Agree, Disagree
Measured: 1 week

Timeline

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

Nov 2015Mar 2016

First posted30 Dec 2015 (estimated)
Study startNov 2015
Primary completionJan 2016
Study completionMar 2016

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: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02642991
Sponsor's protocol ID: CV-15-41
Status last verified: Nov 2020
First submitted: 7 Dec 2015
Last updated: 1 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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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A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dispensing Study for The Phenacite Project
ClinicalTrials.gov ID: NCT02642991
Acronym / sponsor ID: CV-15-41
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2015
Primary completion: Jan 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 30 Dec 2015 (estimated)
Results: Posted 1 Dec 2020

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
Phenacite Test lens then comfilcon A control lens	Experimental	Device: Phenacite, Device: comfilcon AParticipants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week.
Comfilcon A control lens then Phenacite test Lens	Active comparator	Device: Phenacite, Device: comfilcon AParticipants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Oculo-visual examination in the last two years
Between 18 and 35 years of age and has full legal capacity to volunteer
Has read and understood the informed consent letter
Is willing and able to follow instructions and maintain the appointment schedule
Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected

Key exclusion criteria (14 listed)

Has never worn contact lenses before
Any systemic disease affecting ocular health
Is using any systemic or topical medications that will affect ocular health
Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.
Has any ocular pathology or anomaly that would affect the wearing of the lenses

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
Phenacitecontact lens	Device	Comfilcon A control lens then Phenacite test Lens, Phenacite Test lens then comfilcon A control lens
comfilcon Acontact lens	Device	Comfilcon A control lens then Phenacite test Lens, Phenacite Test lens then comfilcon A control lens

Primary outcome

Distance Visual Acuity (VA) - High Illumination
Time frame: Baseline (after 10 minutes of lens dispense)
Distance visual acuity High Illumination was assessed using logMAR
Distance Visual Acuity (VA) - High Illumination
Time frame: 1 week
Distance visual acuity High Illumination was assessed using logMAR
Near Visual Acuity (VA) - High Illumination
Time frame: Baseline (after 10 minutes of lens dispense)
Near Visual Acuity (VA) - High Illumination assessed using logMAR
Near Visual Acuity (VA) - High Illumination
Time frame: 1 week
Near Visual Acuity (VA) - High Illumination assessed using logMAR
Distance Visual Acuity (VA) - Low Illumination
Time frame: Baseline (after 10 minutes of lens dispense)
Distance Visual Acuity (VA) - Low Illumination assessed using logMAR
Distance Visual Acuity (VA) - Low Illumination
Time frame: 1 week
Distance Visual Acuity (VA) - Low Illumination assessed using logMAR
Near Visual Acuity (VA) - Low Illumination
Time frame: Baseline (after 10 minutes of lens dispense)
Near Visual Acuity (VA) - Low illumination assessed using logMAR
Near Visual Acuity (VA) - Low Illumination
Time frame: 1 week
Near Visual Acuity (VA) - Low illumination assessed using logMAR
Quality of Distance Vision
Time frame: Baseline (after 10 minutes of lens dispense)
Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Quality of Distance Vision
Time frame: 1 week
Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Quality of Near Vision
Time frame: Baseline (After 10 minutes of lens dispense)
Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time
Quality of Near Vision
Time frame: 1 week
Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time
Quality of Vision With Digital Device Use
Time frame: Baseline (After 10 minutes of lens dispense)
Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Quality of Vision With Digital Device Use
Time frame: 1 week
Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Quality of Intermediate Vision
Time frame: Baseline (After 10 minutes of lens dispense)
Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Quality of Intermediate Vision
Time frame: 1 week
Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Overall Vision Quality
Time frame: Baseline (After 10 minutes of lens dispense)
Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Overall Vision Quality
Time frame: 1 week
Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)

21 secondary outcomes

Biomicroscopy Findings - Bulbar Hyperemia
Time frame: 1 week
Biomicroscopy Findings- Limbal Hyperemia
Time frame: 1 week
Biomicroscopy Findings - Corneal Staining Extent
Time frame: 1 week
Ghosting - Distance Vision
Time frame: 1 week
Ghosting - Near Vision
Time frame: 1 week
Overall Comfort
Time frame: Baseline (After 10 minutes of lens dispense)
Overall Comfort
Time frame: 1 week
Overall Dryness
Time frame: Baseline (after 10 minutes of lens dispense)
Overall Dryness
Time frame: 1 week
Lens Preference - Overall Vision Preference
Time frame: 1 week
Subjective Ratings of Change in Frequency of Tiredness
Time frame: 1 week
Subjective Ratings of Change in Severity of Tiredness
Time frame: 1 week
Subjective Ratings of Change in Bothersome Rating for Tiredness
Time frame: 1 week
Subjective Ratings of Change in Frequency of Dryness
Time frame: 1 week
Subjective Ratings of Change in Severity of Dryness
Time frame: 1 week
Subjective Ratings of Change in Bothersome Rating of Dryness
Time frame: 1 week
Subjective Questionnaire Response - Eye Strain
Time frame: 1 week
Subjective Questionnaire Response - Eye Feel Good
Time frame: 1 week
Subjective Questionnaire Response - Eye Feel Relaxed
Time frame: 1 week
Subjective Questionnaire Response - Vision
Time frame: 1 week
Subjective Questionnaire Response - Eye Tired
Time frame: 1 week

Results and safety

Results posted to the registry on 1 Dec 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
Phenacite Test Lens Then Comfilcon A Control Lens	22	22
Comfilcon A Control Lens Then Phenacite Test Lens	22	22

Primary outcome: Distance Visual Acuity (VA) - High Illumination

Time frame: Baseline (after 10 minutes of lens dispense). Mean (Standard Deviation). Unit: logMAR

Measure	Phenacite Test Lens n = 44	Comfilcon A Control Lens n = 44
Monocular	-0.10 (0.07)	-0.11 (0.08)
Binocular	-0.15 (0.06)	-0.17 (0.07)

Primary outcome: Distance Visual Acuity (VA) - High Illumination

Time frame: 1 week. Mean (Standard Deviation). Unit: logMAR

Measure	Phenacite Test Lens n = 44	Comfilcon A Control Lens n = 44
Monocular	-0.10 (0.08)	-0.11 (0.08)
Binocular	-0.15 (0.07)	-0.16 (0.06)

Primary outcome: Near Visual Acuity (VA) - High Illumination

Time frame: Baseline (after 10 minutes of lens dispense). Mean (Standard Deviation). Unit: logMAR

Measure	Phenacite Test Lens n = 44	Comfilcon A Control Lens n = 44
Monocular	-0.07 (0.09)	-0.08 (0.08)
Binocular	-0.13 (0.09)	-0.14 (0.08)

Primary outcome: Near Visual Acuity (VA) - High Illumination

Time frame: 1 week. Mean (Standard Deviation). Unit: logMAR

Measure	Phenacite Test Lens n = 44	Comfilcon A Control Lens n = 44
Monocular	-0.06 (0.10)	-0.07 (0.09)
Binocular	-0.11 (0.09)	-0.13 (0.10)

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: From dispense up to one week on each study lenses, a total of two weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phenacite Test Lens	0 of 44 (0%)	0 of 44 (0%)	0 of 44
Comfilcon A Control Lens	0 of 44 (0%)	0 of 44 (0%)	0 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
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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.

Lyndon Jones principal investigator

CCLR, University of Waterloo

Pete Kollbaum, OD, PhD principal investigator

CORL, Indiana University

Meng Lin, OD, PhD principal investigator

CRC, University of California, Berkeley

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Phenacite and comfilcon A in people with Myopia, run by CooperVision, Inc. at 3 sites in 2 countries.

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 14 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 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Canada. 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 1 Dec 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?

Distance Visual Acuity (VA) - High Illumination (time frame: Baseline (after 10 minutes of lens dispense)). The study lists 18 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 NCT02642991.

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 1 Dec 2020.