AstigmatismNCT02410824

Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism

A study testing stenfilcon A toric lens and etafilcon A toric lens in people with Astigmatism, 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

Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism. Read more about this study

Who is it for?: Ages 17 years and older
Conditions the study is for: Astigmatism
What is being tested?: stenfilcon A toric lens and etafilcon A toric lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 2 sitesin 2 countries
Study dates: Apr 2015to Jun 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 a spherical contact lens prescription between -1.00 to -6.00 inclusive in each eye
Has spectacle astigmatism: -0.50 to -1.50D (Diopter) cylinder (Axis: 90±20, 180±20 in both eyes);

Show all 9Show fewer

Willing to wear contact lens in both eyes for at least 8 hours per day, 7 days per week;
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 (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

Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism.

Read the detailed description

CooperVision is evaluating the clinical performance of an FDA cleared silicone-hydrogel lens material stenfilcon A (test) compared to etafilcon A for Astigmatism lens (control) when worn on a daily wear basis over one (1) week in a randomized, bilateral, cross-over, dispensing study.

Conditions: Astigmatism
Being tested: stenfilcon A toric lens, etafilcon A toric lens
Medical subject headings: Astigmatism

What participants receive

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

stenfilcon A toric lensDevice
toric contact lens
etafilcon A toric lensDevice
toric contact lens

Study groups in NCT02410824
Study group	Role	What they receive
stenfilcon A toric lens	Experimental	Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study. Receives: Device: stenfilcon A toric lens
etafilcon A toric lens	Active comparator	Participants were randomized to wear etafilcon A toric lens for one week during the cross over study. Receives: Device: etafilcon A toric lens

What is being measured

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

Comfort
Subjective ratings of lens performance for comfort assessed at baseline and 1 week. Comfort Scale 0-100, 0=extremely uncomfortable/cannot tolerate, 100=extremely comfortable/cannot be felt.
Measured: Baseline and 1 Week
Handling
Subjective ratings of lens performance for handling assessed at baseline and 1 week. Handling Scale 0-100, 0=very difficult to handle, 100=very easy to handle.
Measured: Baseline and 1 Week
Vision
Subjective ratings of lens performance for vision assessed at baseline and 1 week. Scale 0-100, 0=extremely poor vision all of the time, cannot function, 100=excellent.
Measured: Baseline and 1 Week
High Visual Acuity
High illumination high contrast (HIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.
Measured: Baseline and 1 Week
Low Visual Acuity
Low illumination high contrast (LIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.
Measured: Baseline and 1 Week
Lens Surface - Wettability
Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=severely reduced, 4=excellent wettability.
Measured: Baseline and 1 Week
Lens Surface - Deposits
Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=no deposits, 4=severe deposits.
Measured: Baseline and 1 Week
Corneal Staining, Type
Ocular health of corneal staining, type for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining, 4=Severe staining Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior
Measured: Baseline and 1 week
Corneal Staining, Extent
Ocular health of corneal staining (extent) for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. 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 Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior
Measured: Baseline and 1 week
Conjunctival Staining
Ocular health of conjunctival staining for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Measured in 0.50 steps, scale 0-4, 0=None, 1=Minimal diffuse punctate, 2=Coalescent punctate, 3=Confluent, 4= Deep confluent
N - Nasal, T - Temporal, S - Superior, I - Inferior
Measured: Baseline and 1 week
Lens Durability
Lens durability (lens tearing) between stenfilcon A toric lens or etafilcon A toric lens assessed at 1 week. (The number of lens tear or lens nicks found during the one week study).
Measured: 1 Week
Lens Fit Acceptance
Lens fit acceptance (on eye stability) for stenfilcon A and etafilcon A assessed at baseline and 1 week. Scale 0-4, 0=Can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Measured: Baseline and 1 Week

Secondary outcomes (2)

Dryness
Subjective ratings of lens performance for dryness assessed during the day and at the end of the day. Scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time.
Measured: 1 Week
Overall Satisfaction
Overall satisfaction of stenfilcon A and etafilcon A lenses. Scale 0-100, 0=extremely dissatisfied, 100=extremely satisfied.
Measured: Baseline and 1 week

Timeline

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

Apr 2015Jun 2015

First posted8 Apr 2015 (estimated)
Study startApr 2015
Primary completionJun 2015
Study completionJun 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 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: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02410824
Sponsor's protocol ID: CV-15-02
Status last verified: Jul 2017
First submitted: 31 Mar 2015
Last updated: 21 Aug 2017
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 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism
ClinicalTrials.gov ID: NCT02410824
Acronym / sponsor ID: CV-15-02
Conditions: Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2015
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 8 Apr 2015 (estimated)
Results: Posted 8 Mar 2017

Clinical summary

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

Bilateral dispensing clinical trial of stenfilcon A against etafilcon A for astigmatism.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
stenfilcon A toric lens	Experimental	Device: stenfilcon A toric lensParticipants were randomized to wear stenfilcon A toric lens for one week during the cross over study.
etafilcon A toric lens	Active comparator	Device: etafilcon A toric lensParticipants were randomized to wear etafilcon A toric lens for one week 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 a spherical contact lens prescription between -1.00 to -6.00 inclusive in each eye

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
stenfilcon A toric lenstoric contact lens	Device	stenfilcon A toric lens
etafilcon A toric lenstoric contact lens	Device	etafilcon A toric lens

Primary outcome

Comfort
Time frame: Baseline and 1 Week
Subjective ratings of lens performance for comfort assessed at baseline and 1 week. Comfort Scale 0-100, 0=extremely uncomfortable/cannot tolerate, 100=extremely comfortable/cannot be felt.
Handling
Time frame: Baseline and 1 Week
Subjective ratings of lens performance for handling assessed at baseline and 1 week. Handling Scale 0-100, 0=very difficult to handle, 100=very easy to handle.
Vision
Time frame: Baseline and 1 Week
Subjective ratings of lens performance for vision assessed at baseline and 1 week. Scale 0-100, 0=extremely poor vision all of the time, cannot function, 100=excellent.
High Visual Acuity
Time frame: Baseline and 1 Week
High illumination high contrast (HIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.
Low Visual Acuity
Time frame: Baseline and 1 Week
Low illumination high contrast (LIHC) visual acuity for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Visual acuity is measured by logMAR.
Lens Surface - Wettability
Time frame: Baseline and 1 Week
Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=severely reduced, 4=excellent wettability.
Lens Surface - Deposits
Time frame: Baseline and 1 Week
Lens surface of wettability for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=no deposits, 4=severe deposits.
Corneal Staining, Type
Time frame: Baseline and 1 week
Ocular health of corneal staining, type for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Scale 0-4, 0=No staining, 4=Severe staining Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior
Corneal Staining, Extent
Time frame: Baseline and 1 week
Ocular health of corneal staining (extent) for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. 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 Five quadrants: C - Central, N - Nasal, T - Temporal, S - Superior, I - Inferior
Conjunctival Staining
Time frame: Baseline and 1 week
Ocular health of conjunctival staining for stenfilcon A toric lens and etafilcon A toric lens assessed at baseline and 1 week. Measured in 0.50 steps, scale 0-4, 0=None, 1=Minimal diffuse punctate, 2=Coalescent punctate, 3=Confluent, 4= Deep confluent N - Nasal, T - Temporal, S - Superior, I - Inferior
Lens Durability
Time frame: 1 Week
Lens durability (lens tearing) between stenfilcon A toric lens or etafilcon A toric lens assessed at 1 week. (The number of lens tear or lens nicks found during the one week study).
Lens Fit Acceptance
Time frame: Baseline and 1 Week
Lens fit acceptance (on eye stability) for stenfilcon A and etafilcon A assessed at baseline and 1 week. Scale 0-4, 0=Can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.

2 secondary outcomes

Dryness
Time frame: 1 Week
Overall Satisfaction
Time frame: Baseline and 1 week

Results and safety

Results posted to the registry on 8 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stenfilcon A Toric Lens, Then Etafilcon A Toric Lens	22	22
Etafilcon A Toric Lens, Then Stenfilcon A Toric Lens	23	22

Primary outcome: Comfort

Time frame: Baseline and 1 Week. Mean (Standard Deviation). Unit: units on a scale

Measure	Stenfilcon A Toric Lens n = 44	Etafilcon A Toric Lens n = 44
Baseline	88 (13)	78 (18)
1 week	85 (14)	77 (21)

Primary outcome: Handling

Time frame: Baseline and 1 Week. Mean (Standard Deviation). Unit: units on a scale

Measure	Stenfilcon A Toric Lens n = 44	Etafilcon A Toric Lens n = 44
Baseline	87 (12)	81 (16)
1 week	87 (18)	81 (23)

Primary outcome: Vision

Time frame: Baseline and 1 Week. Mean (Standard Deviation). Unit: units on a scale

Measure	Stenfilcon A Toric Lens n = 44	Etafilcon A Toric Lens n = 44
Baseline	83 (16)	78 (21)
1 week	86 (17)	83 (17)

Primary outcome: High Visual Acuity

Time frame: Baseline and 1 Week. Mean (Standard Deviation). Unit: LogMAR

Measure	Stenfilcon A Toric Lens n = 44	Etafilcon A Toric Lens n = 44
Baseline	-0.10 (0.06)	-0.08 (0.06)
1 week	-0.09 (0.07)	-0.09 (0.07)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stenfilcon A Toric Lens	0 of 44 (0%)	0 of 44 (0%)	Not reported
Etafilcon A Toric Lens	0 of 44 (0%)	0 of 44 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
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
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Recruiting
Clareon TruPlus Study
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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 C Lin, OD PhD principal investigator

UC Berkeley Clinical Research Center

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

Questions about this trial

What is this clinical trial studying?

A study testing stenfilcon A toric lens and etafilcon A toric lens in people with Astigmatism, 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 21 Aug 2017. 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 8 Mar 2017). 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?

Comfort (time frame: Baseline and 1 Week). 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 NCT02410824.

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 21 Aug 2017.