MyopiaNCT02553395

One Week Assessment of The Phenacite Lens

A study testing Phenacite (Test) contact lens and comfilcon A contact lens in people with Myopia, run by CooperVision, Inc. at 1 site in United States.

Completed

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

Official record

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Trial summary

This study will investigate performance criteria over one week of daily wear to determine if the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms of subjective ratings and 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 (Test) contact lens and comfilcon A contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Sep 2015to Oct 2015
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 10Show fewer

Currently wears, or has previously successfully worn, soft contact lenses between -1.00D (Diopter) and -4.50D
Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder <-0.75
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.
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 10Show fewer

Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
Is aphakic.
Has undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Bloomington, Indiana, 47405

Other trials in United States

About this study

The study test lens was not the final optical design and the study results were not used for the design validation.

Read the detailed description

This will be double-masked, randomized, bilateral crossover study comparing the Study Test lens against the comfilcon A control lens, each worn over one week of daily wear.

The study test lens was not the final optical design and the study results were not used for the design validation.

Conditions: Myopia
Being tested: Phenacite (Test) contact lens, comfilcon A contact lens
Medical subject headings: Myopia

What participants receive

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

Phenacite (Test) contact lensDevice
comfilcon A contact lensDevice

Study groups in NCT02553395
Study group	Role	What they receive
Phenacite contact lens	Experimental	Study Test Contact Lens Receives: Device: Phenacite (Test) contact lens
comfilcon A contact lens	Active comparator	Control Contact Lens Receives: Device: comfilcon A contact lens

What is being measured

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

Binocular Distance Visual Acuity (VA) - High Illumination High Contrast
Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)
Measured: Baseline - After 5 minutes of lens settling
Binocular Distance Visual Acuity (VA) -High Illumination High Contrast
Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)
Measured: 1 week
Binocular Near Visual Acuity (VA) - High Illumination High Contrast
Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)
Measured: Baseline - after 5 minutes of lens dispense
Binocular Near Visual Acuity (VA) - High Illumination High Contrast
Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)
Measured: 1-week
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Measured: Baseline (After 5 minutes of lens settling)
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Measured: 1 week
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Measured: Baseline (after 5 minutes of lens settling)
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Measured: 1week
Subjective Ratings for Distance Quality of Vision
Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Distance Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)
Measured: 1 week
Subjective Ratings for Intermediate Quality of Vision
Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Intermediate Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)
Measured: 1 week
Subjective Ratings for Near Quality of Vision
Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Near Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)
Measured: 1 week

Secondary outcomes (12)

Post Blink Movement -
Post blink movement was assessed by the investigator by the amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Measured: Baseline (After 5 minutes of lens dispense)
Post Blink Movement
Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Measured: 1 week
Push - Up Test for Lens Tightness
Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
Measured: Baseline (After 5 minutes of lens dispense)
Push - Up Test for Lens Tightness
Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
Measured: 1 week
Lens Mobility Rating
Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps
Measured: Baseline (after 5 minutes of lens dispense)
Lens Mobility Rating
Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps
Measured: 1 week
Overall Lens Fit Acceptance
Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
Measured: Baseline (After 5 minutes of lens dispense)
Overall Lens Fit Acceptance
Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn,, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
Measured: 1 week
Subjective Lens Preference - Distance Vision
Patient subjective preference: Phenacite lens, comfilcon A or No Preference
Measured: 1 week
Subjective Lens Preference -Overall Vision Preference
Patient subjective preference: Phenacite test lens, comfilcon A or No Preference
Measured: 1 week
Subjective Lens Preference - Comfort
Patient subjective preference: Phenacite test lens, comfilcon A or No Preference
Measured: 1 week
Subjective Overall Lens Preference
Patient subjective overall preference: Phenacite test lens, comfilcon A or No Preference
Measured: 1 week

Timeline

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

Sep 2015Oct 2015

First posted17 Sep 2015 (estimated)
Study startSep 2015
Primary completionSep 2015
Study completionOct 2015

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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02553395
Sponsor's protocol ID: CV-15-40
Status last verified: Nov 2020
First submitted: 14 Sep 2015
Last updated: 22 Dec 2020
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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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Clinical Performance and Outcomes After Toric Lens Transition
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Active, not recruiting
Effect of IOP Lowering on Progressive HM
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: One Week Assessment of The Phenacite Lens
ClinicalTrials.gov ID: NCT02553395
Acronym / sponsor ID: CV-15-40
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: Sep 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 17 Sep 2015 (estimated)
Results: Posted 22 Dec 2020

Clinical summary

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

The study test lens was not the final optical design and the study results were not used for the design validation.

Detailed description

This will be double-masked, randomized, bilateral crossover study comparing the Study Test lens against the comfilcon A control lens, each worn over one week of daily wear.

The study test lens was not the final optical design and the study results were not used for the design validation.

Study design

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

Arm	Type	Receives
Phenacite contact lens	Experimental	Device: Phenacite (Test) contact lensStudy Test Contact Lens
comfilcon A contact lens	Active comparator	Device: comfilcon A contact lensControl Contact Lens

Who may qualify

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

Key inclusion criteria (10 listed)

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

Key exclusion criteria (10 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
Phenacite (Test) contact lens	Device	Phenacite contact lens
comfilcon A contact lens	Device	comfilcon A contact lens

Primary outcome

Binocular Distance Visual Acuity (VA) - High Illumination High Contrast
Time frame: Baseline - After 5 minutes of lens settling
Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)
Binocular Distance Visual Acuity (VA) -High Illumination High Contrast
Time frame: 1 week
Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)
Binocular Near Visual Acuity (VA) - High Illumination High Contrast
Time frame: Baseline - after 5 minutes of lens dispense
Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)
Binocular Near Visual Acuity (VA) - High Illumination High Contrast
Time frame: 1-week
Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast
Time frame: Baseline (After 5 minutes of lens settling)
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast
Time frame: 1 week
Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast
Time frame: Baseline (after 5 minutes of lens settling)
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast
Time frame: 1week
Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Subjective Ratings for Distance Quality of Vision
Time frame: 1 week
Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Distance Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)
Subjective Ratings for Intermediate Quality of Vision
Time frame: 1 week
Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Intermediate Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)
Subjective Ratings for Near Quality of Vision
Time frame: 1 week
Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Near Quality of Vision: (0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time)

12 secondary outcomes

Post Blink Movement -
Time frame: Baseline (After 5 minutes of lens dispense)
Post Blink Movement
Time frame: 1 week
Push - Up Test for Lens Tightness
Time frame: Baseline (After 5 minutes of lens dispense)
Push - Up Test for Lens Tightness
Time frame: 1 week
Lens Mobility Rating
Time frame: Baseline (after 5 minutes of lens dispense)
Lens Mobility Rating
Time frame: 1 week
Overall Lens Fit Acceptance
Time frame: Baseline (After 5 minutes of lens dispense)
Overall Lens Fit Acceptance
Time frame: 1 week
Subjective Lens Preference - Distance Vision
Time frame: 1 week
Subjective Lens Preference -Overall Vision Preference
Time frame: 1 week
Subjective Lens Preference - Comfort
Time frame: 1 week
Subjective Overall Lens Preference
Time frame: 1 week

Results and safety

Results posted to the registry on 22 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 Contact Lens Then Comfilcon A	12	12
Comfilcon A Contact Lens Then Phenacite Contact Lens	18	18

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

Time frame: Baseline - After 5 minutes of lens settling. Mean (Standard Deviation). Unit: logMAR

Measure	Phenacite Contact Lens n = 30	Comfilcon A Contact Lens n = 30
Value	-0.22 (0.05)	-0.24 (0.05)

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

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

Measure	Phenacite Contact Lens n = 30	Comfilcon A Contact Lens n = 30
Value	-0.20 (0.05)	-0.22 (0.06)

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

Time frame: Baseline - after 5 minutes of lens dispense. Mean (Standard Deviation). Unit: logMAR

Measure	Phenacite Contact Lens n = 30	Comfilcon A Contact Lens n = 30
Value	-0.18 (0.06)	-0.19 (0.07)

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

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

Measure	Phenacite Contact Lens n = 30	Comfilcon A Contact Lens n = 30
Value	-0.19 (0.06)	-0.19 (0.06)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: From dispense up to one week on each study lens, a total of 2 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phenacite Contact Lens	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Comfilcon A Contact Lens	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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
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Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
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Active, not recruiting
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Recruiting
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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.

Peter Kollbaum, OD, PhD principal investigator

Clinical Optics Research Lab (CORL)

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

Questions about this trial

What is this clinical trial studying?

A study testing Phenacite (Test) contact lens and comfilcon A contact lens in people with Myopia, run by CooperVision, Inc. 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 10 inclusion and 10 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 22 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 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. 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 22 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?

Binocular Distance Visual Acuity (VA) - High Illumination High Contrast (time frame: Baseline - After 5 minutes of lens settling). The study lists 11 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 NCT02553395.

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 22 Dec 2020.