AstigmatismNCT02555098

A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens

A study testing Sapphire contact lenses and senofilcon A contact lenses in people with Astigmatism, 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 was conducted to evaluate the clinical performance of an investigational silicone-hydrogel lens against Senofilcon A toric lens. The study results were not used for design validation of the investigational product. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Astigmatism
What is being tested?: Sapphire contact lenses and senofilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: Sep 2015to Apr 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

A person is eligible for inclusion in the study if they:
Are at least 18 years of age and have full legal capacity to volunteer;
Have read and signed an information consent letter;
Are willing and able to follow instructions and maintain the appointment schedule;
Are an adapted soft contact lens wearer;
Require spectacle lens powers in both eyes;

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Sphere: between -1.75 to -6.00 diopters and
Astigmatism: between -1.00 to -2.25 and
Axis: 180 ± 20 degrees
Are willing to wear contact lenses in both eyes;
Have manifest refraction visual acuities (VA) equal to or better than logMAR (log of the minimum angle of resolution) 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 including toric orientation as acceptable.

Who cannot join

A person will be excluded from the study if they:
Are participating in any concurrent clinical or research study;
Have any known active* ocular disease and/or infection;
Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;

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Are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
Are aphakic;
Have undergone refractive error surgery;

Trial locations and contacts

1 site in 1 country.

United States1 site

Family Eye Care Center
Campbell, California, 95008

Other trials in United States

About this study

Official title: A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens Over 2 Weeks

This study was conducted to evaluate the clinical performance of an investigational silicone-hydrogel lens against Senofilcon A toric lens.

The study results were not used for design validation of the investigational product.

Read the detailed description

This will be a randomized, bilateral, 2-week cross-over, double-masked, dispensing study comparing the investigational test lens against the Senofilcon A Toric for Astigmatism control lens.

Conditions: Astigmatism
Being tested: Sapphire contact lenses, senofilcon A contact lenses
Medical subject headings: Astigmatism

What participants receive

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

Sapphire contact lensesDevice
Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair
senofilcon A contact lensesDevice
Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair

Study groups in NCT02555098
Study group	Role	What they receive
Sapphire contact lenses	Experimental	Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair. Receives: Device: Sapphire contact lenses
senofilcon A	Active comparator	Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair. Receives: Device: senofilcon A contact lenses

What is being measured

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

Subjective Ratings for Comfort
Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)
Measured: Baseline (10 minutes post lens settling)
Subjective Ratings for Comfort
Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)
Measured: 2 weeks
Subjective Ratings for Comfort Preference
Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference
Measured: Baseline (10 minutes post lens settling)
Subjective Ratings for Comfort Preference
Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference
Measured: 2 weeks
Subjective Assessment of Visual Quality
Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)
Measured: Baseline (10 minutes post lens settling)
Subjective Assessment of Visual Quality
Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)
Measured: 2 weeks
Subjective Assessment of Overall Satisfaction
Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)
Measured: Baseline (10 minutes post lens settling)
Subjective Assessment of Overall Satisfaction
Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)
Measured: 2 weeks
Subjective Overall Preference
Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference
Measured: Baseline (10 minutes post lens settling)
Subjective Overall Preference
Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference
Measured: 2 weeks

Timeline

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

Sep 2015Apr 2016

First posted21 Sep 2015 (estimated)
Study startSep 2015
Primary completionFeb 2016
Study completionApr 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 AstigmatismStudies 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: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02555098
Sponsor's protocol ID: CV-15-15
Status last verified: Sep 2020
First submitted: 4 Sep 2015
Last updated: 19 Oct 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

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism

All Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 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 Toric for Astigmatism Lens Over 2 Weeks
ClinicalTrials.gov ID: NCT02555098
Acronym / sponsor ID: CV-15-15
Conditions: Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: Feb 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 21 Sep 2015 (estimated)
Results: Posted 23 Sep 2020

Clinical summary

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

This study was conducted to evaluate the clinical performance of an investigational silicone-hydrogel lens against Senofilcon A toric lens.

The study results were not used for design validation of the investigational product.

Detailed description

This will be a randomized, bilateral, 2-week cross-over, double-masked, dispensing study comparing the investigational test lens against the Senofilcon A Toric for Astigmatism control lens.

Study design

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

Arm	Type	Receives
Sapphire contact lenses	Experimental	Device: Sapphire contact lensesEach subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair.
senofilcon A	Active comparator	Device: senofilcon A contact lensesEach subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

A person is eligible for inclusion in the study if they:

Key exclusion criteria (9 listed)

A person will be excluded from the study if they:

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
Sapphire contact lensesEach subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair	Device	Sapphire contact lenses
senofilcon A contact lensesEach subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair	Device	senofilcon A

Primary outcome

Subjective Ratings for Comfort
Time frame: Baseline (10 minutes post lens settling)
Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)
Subjective Ratings for Comfort
Time frame: 2 weeks
Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)
Subjective Ratings for Comfort Preference
Time frame: Baseline (10 minutes post lens settling)
Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference
Subjective Ratings for Comfort Preference
Time frame: 2 weeks
Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference
Subjective Assessment of Visual Quality
Time frame: Baseline (10 minutes post lens settling)
Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)
Subjective Assessment of Visual Quality
Time frame: 2 weeks
Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)
Subjective Assessment of Overall Satisfaction
Time frame: Baseline (10 minutes post lens settling)
Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)
Subjective Assessment of Overall Satisfaction
Time frame: 2 weeks
Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)
Subjective Overall Preference
Time frame: Baseline (10 minutes post lens settling)
Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference
Subjective Overall Preference
Time frame: 2 weeks
Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference

Results and safety

Results posted to the registry on 23 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 Test Lenses Then Senofilcon A Lenes	12	12
Senofilcon A Then Sapphire Test Lenses	11	11

Primary outcome: Subjective Ratings for Comfort

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

Measure	Sapphire Lenses n = 22	Senofilcon A n = 22
Value	89 (14)	80 (20)

Population analysed: One subject was excluded from the analysis due to compliance.

Primary outcome: Subjective Ratings for Comfort

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

Measure	Sapphire Lenses n = 22	Senofilcon A n = 22
Value	85 (18)	72 (27)

Population analysed: One subject was excluded from the analysis due to compliance.

Primary outcome: Subjective Ratings for Comfort Preference

Time frame: Baseline (10 minutes post lens settling). Number. Unit: percentage of participants

Measure	Overall Study n = 22
Sapphire lens	46
senofilcon A	18
No Preference	36

Population analysed: One subject was excluded from the analysis due to compliance.

Primary outcome: Subjective Ratings for Comfort Preference

Time frame: 2 weeks. Number. Unit: percentage of participants

Measure	Overall Study n = 22
Sapphire lens	68
senofilcon A	27
No Preference	5

Population analysed: One subject was excluded from the analysis due to compliance.

Adverse events

Time frame: From dispense up to 2 weeks on each study lenses, a total of 4 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sapphire Contact Lenses	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Senofilcon A	0 of 23 (0%)	0 of 23 (0%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Astigmatism

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism

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.

Michel Guillon principal investigator

Ocular Technology Group

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

Questions about this trial

What is this clinical trial studying?

A study testing Sapphire contact lenses and senofilcon A contact lenses in people with Astigmatism, 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 9 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 19 Oct 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 23 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?

Subjective Ratings for Comfort (time frame: Baseline (10 minutes post lens settling)). The study lists 10 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 NCT02555098.

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 19 Oct 2020.