MyopiaNCT02345811

A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks

A study testing Sapphire and senofilcon A in people with Myopia and Hyperopia, run by CooperVision, Inc. at 2 sites in 2 countries.

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

To evaluate the clinical performance of an investigational silicone-hydrogel lens when worn on a daily wear modality over two weeks of lens wear. Read more about this study

Who is it for?: Ages 17 years and older
Conditions the study is for: Myopia, Hyperopia
What is being tested?: Sapphire and senofilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 2 sitesin 2 countries
Study dates: Jan 2015to Mar 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 17 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Is at least 17 years of age for Canada and 18 years of age for the USA and has full legal capacity to volunteer
Has read and signed an information consent letter
Is willing and able to follow instructions and maintain the appointment schedule;
Is an adapted soft contact lens wearer
Requires spectacle lens powers between -0.50 to -6.00 diopters sphere (0.25D steps) or +1.00 to +8.00 diopters sphere (1.00D steps)
Has no more than 0.75 diopters of refractive astigmatism

Show all 9Show fewer

Willing to wear contact lens in both eyes
Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye
To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable

Who cannot join

Is participating in any concurrent clinical or research study
Has any known active* ocular disease and/or infection
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study
Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit)
Is aphakic
Has undergone refractive error surgery

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Clinical Research Center, University of California, Berkeley
Berkeley, California, 94704

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

To evaluate the clinical performance of an investigational silicone-hydrogel lens when worn on a daily wear modality over two weeks of lens wear.

Read the detailed description

This was a randomized, bilateral, 2 week cross over, double-masked, dispensing study comparing Sapphire test lens against the senofilcon A control lens. This study results were not used to support design validation of the test lens.

Conditions: Myopia, Hyperopia
Being tested: Sapphire, senofilcon A
Medical subject headings: Myopia, Hyperopia

What participants receive

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

SapphireDevice
silicone-hydrogel contact lens
senofilcon ADevice
contact lens

Study groups in NCT02345811
Study group	Role	What they receive
Sapphire	Experimental	Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study. Receives: Device: Sapphire
senofilcon A	Active comparator	Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study. Receives: Device: senofilcon A

What is being measured

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

Vision Quality
Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)
Measured: Baseline (10 minutes post lens settling at dispense)
Vision Quality
Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)
Measured: 2 weeks - During the Day
Vision Quality
Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)
Measured: 2 weeks - End of Day
Subjective Rating for Comfort.
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Measured: Baseline - 10 minutes post lens settling
Subjective Rating for Comfort.
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Measured: 2-weeks - During the Day
Subjective Rating for Comfort.
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Measured: 2-weeks - End of Day
Lens Surface Wettability
Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)
Measured: Baseline (10 minutes post lens settling)
Lens Surface Wettability
Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)
Measured: 2 weeks
Surface Deposits
Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = <5 deposits; 2 = >5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits >0.5mm or film > 75% of surface)
Measured: Baseline (10 minutes post lens settling)
Surface Deposits
Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = <5 deposits; 2 = >5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits >0.5mm or film > 75% of surface)
Measured: 2-weeks
Lens Handling (Ease of Insertion)
Lens handling - ease of insertion of the lenses. Scale 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye.
Measured: 2 weeks
Lens Handling (Ease of Removal)
Lens handling - ease of removal of the lenses. Scale 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye.
Measured: 2 weeks
Subjective Preference for Comfort.
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Measured: Baseline - 10 minutes post lens settling
Subjective Preference for Comfort.
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Measured: 2 weeks

Timeline

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

Jan 2015Mar 2015

First posted26 Jan 2015 (estimated)
Study startJan 2015
Primary completionMar 2015
Study completionMar 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02345811
Sponsor's protocol ID: CV-15-01
Status last verified: Jul 2020
First submitted: 14 Jan 2015
Last updated: 16 Sep 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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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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Active, not recruiting
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Recruiting
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks
ClinicalTrials.gov ID: NCT02345811
Acronym / sponsor ID: CV-15-01
Conditions: Myopia, Hyperopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2015
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 26 Jan 2015 (estimated)
Results: Posted 16 Sep 2020

Clinical summary

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

To evaluate the clinical performance of an investigational silicone-hydrogel lens when worn on a daily wear modality over two weeks of lens wear.

Detailed description

Study design

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

Arm	Type	Receives
Sapphire	Experimental	Device: SapphireParticipants were randomized to wear the Sapphire lens pair for two weeks during the cross over study.
senofilcon A	Active comparator	Device: senofilcon AParticipants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study.

Who may qualify

Ages: 17 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

Is at least 17 years of age for Canada and 18 years of age for the USA and has full legal capacity to volunteer
Has read and signed an information consent letter
Is willing and able to follow instructions and maintain the appointment schedule;
Is an adapted soft contact lens wearer
Requires spectacle lens powers between -0.50 to -6.00 diopters sphere (0.25D steps) or +1.00 to +8.00 diopters sphere (1.00D steps)

Key exclusion criteria (8 listed)

Is participating in any concurrent clinical or research study
Has any known active* ocular disease and/or infection
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study

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
Sapphiresilicone-hydrogel contact lens	Device	Sapphire
senofilcon Acontact lens	Device	senofilcon A

Primary outcome

Vision Quality
Time frame: Baseline (10 minutes post lens settling at dispense)
Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)
Vision Quality
Time frame: 2 weeks - During the Day
Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)
Vision Quality
Time frame: 2 weeks - End of Day
Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)
Subjective Rating for Comfort.
Time frame: Baseline - 10 minutes post lens settling
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Subjective Rating for Comfort.
Time frame: 2-weeks - During the Day
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Subjective Rating for Comfort.
Time frame: 2-weeks - End of Day
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Lens Surface Wettability
Time frame: Baseline (10 minutes post lens settling)
Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)
Lens Surface Wettability
Time frame: 2 weeks
Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)
Surface Deposits
Time frame: Baseline (10 minutes post lens settling)
Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = <5 deposits; 2 = >5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits >0.5mm or film > 75% of surface)
Surface Deposits
Time frame: 2-weeks
Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = <5 deposits; 2 = >5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits >0.5mm or film > 75% of surface)
Lens Handling (Ease of Insertion)
Time frame: 2 weeks
Lens handling - ease of insertion of the lenses. Scale 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye.
Lens Handling (Ease of Removal)
Time frame: 2 weeks
Lens handling - ease of removal of the lenses. Scale 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye.
Subjective Preference for Comfort.
Time frame: Baseline - 10 minutes post lens settling
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Subjective Preference for Comfort.
Time frame: 2 weeks
Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever

Results and safety

Results posted to the registry on 16 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
Sapphire Lens Then Senofilcon A	17	16
Senofilcon A Then Sapphire Lens	17	16

Primary outcome: Vision Quality

Time frame: Baseline (10 minutes post lens settling at dispense). Mean (Standard Deviation). Unit: units on a scale

Measure	Sapphire n = 32	Senofilcon A n = 32
Value	93 (9)	94 (7)

Primary outcome: Vision Quality

Time frame: 2 weeks - During the Day. Mean (Standard Deviation). Unit: units on a scale

Measure	Sapphire n = 32	Senofilcon A n = 32
Value	88 (12)	91 (11)

Primary outcome: Vision Quality

Time frame: 2 weeks - End of Day. Mean (Standard Deviation). Unit: units on a scale

Measure	Sapphire n = 32	Senofilcon A n = 32
Value	86 (14)	87 (14)

Primary outcome: Subjective Rating for Comfort.

Time frame: Baseline - 10 minutes post lens settling. Mean (Standard Deviation). Unit: units on a scale

Measure	Sapphire n = 32	Senofilcon A n = 32
Value	91 (12)	92 (11)

Adverse events

Time frame: From dispense up to 2 weeks for each study lenses, a total of 4 weeks. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sapphire	0 of 32 (0%)	2 of 32 (6.3%)	0 of 32
Senofilcon A	0 of 32 (0%)	2 of 32 (6.3%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

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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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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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Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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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.

Meng Lin, OD PhD principal investigator

University of California, Berkeley

Lyndon Jones, PhD FCO principal investigator

University of Waterloo CCLR

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

Questions about this trial

What is this clinical trial studying?

A study testing Sapphire and senofilcon A in people with Myopia and Hyperopia, run by CooperVision, Inc. at 2 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 9 inclusion and 8 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 16 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 2 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 16 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?

Vision Quality (time frame: Baseline (10 minutes post lens settling at dispense)). The study lists 14 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 NCT02345811.

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 16 Sep 2020.