MyopiaNCT03360110

Comparison of New Contact Lens With Current Marketed Lens

A study testing Phoebe test 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.

Trial summary

The purpose of this study is to validate the clinical performance of a new contact lens design. Read more about this study

Who is it for?: Ages 18 to 35 years
Conditions the study is for: Myopia
What is being tested?: Phoebe test lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteUnited States
Study dates: 6 Nov 2017to 15 Dec 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 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:
Between and 18 and 35 years of age and has full legal capacity to volunteer
Has had a self-reported oculo-visual examination in the last two years
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 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected

Show all 12Show fewer

Has a Contact Lens Refraction between -1.00D and -6.00D
Cylinder power ≤ -0.75DC in Spherical Cylindrical Refraction
Currently wears soft contact lenses
Is willing to wear lenses for a minimal of 8 hours a day and everyday during the course of the study
Has clear corneas and no active ocular disease
Has not worn lenses for at least 12 hours before the first visit

Who cannot join

A person will be excluded from the study if he/she:
Has never worn contact lenses before
Is wearing Monovision modality
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

Show all 11Show fewer

Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
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 Optical Research Lab (CORL)
Bloomington, Indiana, 47405

Other trials in United States

About this study

Official title: Clinical Validation Study of Phoebe Lens

The purpose of this study is to validate the clinical performance of a new contact lens design.

Read the detailed description

Evaluate the clinical performance of its Phoebe contact lenses (Test) compared to the commercially available MyDay contact lenses (Control).

Conditions: Myopia
Being tested: Phoebe test lens, 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.

Phoebe test lensDevice
Also called Test Lens, Phoebe Contact Lens
Daily disposable contact lens
stenfilcon A lens (control)Device
Also called MyDay daily disposable contact lens
Daily disposable contact lens

Study groups in NCT03360110
Study group	Role	What they receive
Test lens	Active comparator	Subjects randomized to wear pair of test lens either first or second Receives: Device: Phoebe test lens; Device: stenfilcon A lens (control)
stenfilcon A lens (control)	Active comparator	Subjects randomized to wear pair of control lens either first or second Receives: Device: Phoebe test lens; Device: stenfilcon A lens (control)

What is being measured

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

Corneal Staining Extent
Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 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: Baseline
Corneal Staining Extent
Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 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: Day 3
Conjunctival Staining Score
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Measured: Baseline
Conjunctival Staining Score
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Measured: Day 3
Palpebral Hyperemia on Upper Lid
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Measured: Baseline
Palpebral Hyperemia on Upper Lid
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Measured: Day 3
Palpebral Hyperemia on Lower Lid
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Measured: Baseline
Palpebral Hyperemia on Lower Lid
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Measured: Day 3
Palpebral Roughness Grade - Upper Lid
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Measured: Baseline
Palpebral Roughness Grade - Upper Lid
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Measured: Day 3
Palpebral Roughness Grade - Lower Lid
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Measured: Baseline
Palpebral Roughness Grade - Lower Lid
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Measured: Day 3

Secondary outcomes (6)

Distance Visual Acuity
Distance visual acuity recorded in logMAR.
Measured: Baseline (at lens dispense)
Distance Visual Acuity
Distance visual acuity recorded in logMAR.
Measured: Day 3
Near Visual Acuity
Near visual acuity recorded in logMAR
Measured: Baseline (at dispense)
Near Visual Acuity
Near visual acuity recorded in logMAR
Measured: Day 3
Vision Quality Rating
Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)
Measured: Baseline (at dispense)
Vision Quality Rating
Subjective vision quality rated on a 0-10 scale (0=extremely poor, 10=excellent)
Measured: Day 3

Timeline

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

6 Nov 201715 Dec 2017

First posted2 Dec 2017
Study start6 Nov 2017
Primary completion15 Dec 2017
Study completion15 Dec 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: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03360110
Sponsor's protocol ID: CV-17-60
Status last verified: Aug 2020
First submitted: 21 Nov 2017
Last updated: 2 Sep 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

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Active, not recruiting
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Validation Study of Phoebe Lens
ClinicalTrials.gov ID: NCT03360110
Acronym / sponsor ID: CV-17-60
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 6 Nov 2017 (actual)
Primary completion: 15 Dec 2017 (actual)
Study completion: 15 Dec 2017 (actual)
First posted: 2 Dec 2017 (actual)
Results: Posted 2 Sep 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 validate the clinical performance of a new contact lens design.

Detailed description

Evaluate the clinical performance of its Phoebe contact lenses (Test) compared to the commercially available MyDay contact lenses (Control).

Study design

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

Arm	Type	Receives
Test lens	Active comparator	Device: Phoebe test lens, Device: stenfilcon A lens (control)Subjects randomized to wear pair of test lens either first or second
stenfilcon A lens (control)	Active comparator	Device: Phoebe test lens, Device: stenfilcon A lens (control)Subjects randomized to wear pair of control lens either first or second

Who may qualify

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

Key inclusion criteria (12 listed)

Between and 18 and 35 years of age and has full legal capacity to volunteer
Has had a self-reported oculo-visual examination in the last two years
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 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected

Key exclusion criteria (11 listed)

Has never worn contact lenses before
Is wearing Monovision modality
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

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
Phoebe test lensAlso: Test Lens, Phoebe Contact LensDaily disposable contact lens	Device	Test lens, stenfilcon A lens (control)
stenfilcon A lens (control)Also: MyDay daily disposable contact lensDaily disposable contact lens	Device	Test lens, stenfilcon A lens (control)

Primary outcome

Corneal Staining Extent
Time frame: Baseline
Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=>45% of area).
Corneal Staining Extent
Time frame: Day 3
Measurement of extent of corneal staining using Fluorescein, blue light, yellow filter, full beam, medium magnification on a scale 0-4 (0=no staining, 1 = 1-15% of area, 2= 16-30% of area, 3=31-45% of area, 4=>45% of area).
Conjunctival Staining Score
Time frame: Baseline
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Conjunctival Staining Score
Time frame: Day 3
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=Deep Confluent, in 0.50 steps
Palpebral Hyperemia on Upper Lid
Time frame: Baseline
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Palpebral Hyperemia on Upper Lid
Time frame: Day 3
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Palpebral Hyperemia on Lower Lid
Time frame: Baseline
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Palpebral Hyperemia on Lower Lid
Time frame: Day 3
Measurement of hyperemia of the palpebral conjunctiva; graded 0-4 (0=none, 4=severe) in 0.25 steps
Palpebral Roughness Grade - Upper Lid
Time frame: Baseline
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Palpebral Roughness Grade - Upper Lid
Time frame: Day 3
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Palpebral Roughness Grade - Lower Lid
Time frame: Baseline
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps
Palpebral Roughness Grade - Lower Lid
Time frame: Day 3
Measurement of smoothness of palpebral conjunctiva; graded 0-4 (0=smooth, 4=severe) in 0.25 steps

6 secondary outcomes

Distance Visual Acuity
Time frame: Baseline (at lens dispense)
Distance Visual Acuity
Time frame: Day 3
Near Visual Acuity
Time frame: Baseline (at dispense)
Near Visual Acuity
Time frame: Day 3
Vision Quality Rating
Time frame: Baseline (at dispense)
Vision Quality Rating
Time frame: Day 3

Results and safety

Results posted to the registry on 2 Sep 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	27	27
Control Lens, Then Test Lens	26	26

Primary outcome: Corneal Staining Extent

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

Measure	Phoebe Test Lens n = 47	Stenfilcon A Control Lens n = 47
Value	0.04 (0.09)	0.04 (0.09)

Population analysed: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Primary outcome: Corneal Staining Extent

Time frame: Day 3. Mean (Standard Deviation). Unit: units on a scale

Measure	Phoebe Test Lens n = 47	Stenfilcon A Control Lens n = 47
Value	0.07 (0.13)	0.07 (0.12)

Population analysed: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Primary outcome: Conjunctival Staining Score

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

Measure	Phoebe Test Lens n = 47	Stenfilcon A Control Lens n = 47
Value	0.18 (0.21)	0.18 (0.21)

Population analysed: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

Primary outcome: Conjunctival Staining Score

Time frame: Day 3. Mean (Standard Deviation). Unit: score on a scale

Measure	Phoebe Test Lens n = 47	Stenfilcon A Control Lens n = 47
Value	0.26 (0.26)	0.29 (0.28)

Population analysed: There were 6 protocol deviations reported in this study and data from the 6 subjects were not used for data analyses.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From dispense up to three days for each intervention.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Lens	0 of 53 (0%)	0 of 53 (0%)	0 of 53
Stenfilcon A Lens (Control)	0 of 53 (0%)	0 of 53 (0%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Myopia

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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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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 S Kolbaum, O.D., Ph.D., FAAO, FBCLA principal investigator

Clinical Optics Research Lab (CORL), Indiana University

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

Questions about this trial

What is this clinical trial studying?

A study testing Phoebe test 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 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 2 Sep 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 2 Sep 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?

Corneal Staining Extent (time frame: Baseline). The study lists 12 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 NCT03360110.

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 2 Sep 2020.