MyopiaNCT01354223

Clinical Evaluation of Stenfilcon A Soft Contact Lens When Compared to Ocufilcon B Soft Contact Lens

A study testing stenfilcon A contact lens and ocufilcon B contact lens in people with Myopia, run by CooperVision, Inc. at 4 sites 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 seeks to evaluate a new daily disposable contact lens compared to an existing daily disposable contact lens. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia
What is being tested?: stenfilcon A contact lens and ocufilcon B contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 4 sitesUnited States
Study dates: Oct 2010to Apr 2011
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

Prior to being considered eligible to participate in this study, each subject MUST:
Be at least 18 years of age as of the date of evaluation for the study.
Have:
Read the Informed Consent
been given an explanation of the Informed Consent
indicated understanding of the Informed Consent

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signed the Informed Consent document.
Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses on a daily basis for at least 8 hours per day for at least one month prior to participation in the study.
Possess wearable and visually functional eyeglasses.
Be in good general health, based on his/her knowledge.
Require spectacle lens powers between -1.00 and -6.00 diopters sphere with no more than 1.00 diopter of refractive astigmatism and be willing to wear contact lenses in both eyes.
Have manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 in each eye.
Upon completing the fitting process with the lenses to be worn in the study, have contact lens Snellen VA equal to or better than 20/30 in each eye.

Who cannot join

Subjects may not be enrolled in this study if any of the following apply: The subject is/has:
Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes. NOTE: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.
Poor personal hygiene.
Any active participation in another clinical trial within 30 days prior to this study.
Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 months.
A member, relative or household member of the investigator or of the investigational office staff.

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Has a known sensitivity to ingredients used in the over the counter contact lens lubricants approved for use in the study.
Previous refractive surgery; or current or previous orthokeratology treatment.
Is aphakic or psuedophakic.
Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermia, keratoconus or type II diabetes.
The need for topical ocular medications or any medication which might interfere with contact lens wear or which would require the lenses to be removed during the day.
The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
A history of papillary conjunctivitis that has interfered with contact lens wear.
Slit lamp findings that would contraindicate contact lens wear, including but not limited to:
Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining > Grade 2
Pterygium
Corneal scars within the visual axis
Neovascularization or ghost vessels > 1.0 mm in from the limbus
Giant papillary conjunctivitis (GPC) of > Grade 2
Anterior uveitis or iritis
Seborrheic eczema, seborrheic conjunctivitis or blepharitis
To be eligible to be randomized for study product a subject must have ALL of the Inclusion Criteria and have NONE of the exclusion criteria present.
To be eligible for lens dispensing (either Test or Control), the subject's study lens contact lens visual acuity must be equal to or better than 20/30 in each eye.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Western Reserve Vision Care
Beachwood, Ohio, 44122
Primary Eyecare Group, P.C.
Brentwood, Tennessee, 37027
Vision Care Associates
East Lansing, Michigan, 48823
Eric M. White, OD, Inc.
San Diego, California, 92123

Other trials in United States

About this study

Official title: Evaluation of the CooperVision Stenfilcon A Soft Contact Lens for Daily Wear When Compared to the CooperVision Ocufilcon B Soft Contact Lens

This study seeks to evaluate a new daily disposable contact lens compared to an existing daily disposable contact lens.

Read the detailed description

This study is designed to evaluate the stenfilcon A contact lens to demonstrate substantial equivalence to the Ocufilcon B for market release.

Conditions: Myopia
Being tested: stenfilcon A contact lens, ocufilcon B contact lens
Keywords: silicone hydrogel contact lens, SHCL, stenfilcon A, ocufilcon B, daily disposable, substantial equivalence, CooperVision ClearSight™ 1 Day SCL
Medical subject headings: Myopia

What participants receive

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

stenfilcon A contact lensDevice
Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
ocufilcon B contact lensDevice
Also called CooperVision ClearSight™ 1 Day
Daily disposable contact lens worn in a daily wear, daily disposable mode

Study groups in NCT01354223
Study group	Role	What they receive
stenfilcon A contact lens	Experimental	Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode Receives: Device: stenfilcon A contact lens
ocufilcon B contact lens	Active comparator	Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode Receives: Device: ocufilcon B contact lens

What is being measured

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

Objective Assessment: Ocular Response - Biomicroscopy
The primary safety endpoint are the objective slit lamp findings associated with the stenfilcon A contact lenses compared with those same findings reported as associated with the ocufilcon B contact lenses.
The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline (baseline visit) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit, month 2 visit combined).The average grade for unique eyes with findings greater than 0 (none) is compared.
Measured: Change from baseline visit and all follow-ups visits
Comparison of Objective Findings - Number of Adverse Events in Unique Eyes
The primary safety endpoint in this evaluation will be a comparison of the objective findings of the number of adverse events in unique eyes associated with the stenfilcon A contact lenses compared with those same findings as associated with ocufilcon B contact lenses.
The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence after dispensing (dispensing visit) through end of month 3 visit (month 3 visit).
Measured: Any occurrence from dispensing to month 3 visit
Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better
The primary efficacy endpoint are the contact lens Snellen visual acuities (VA) of 20/25 VA or better associated with stenfilcon A compared with those same visual acuities associated with ocufilcon B.
Snellen visual acuity (VA) examinations were performed at All Follow-up visits (week 1 visit, week 2 visit, month 1 visit, month 2 visit). The combined results of All Follow-up visits are compared.
Measured: week 1 visit, week 2 visit, month 1 visit, month 2 visit combined

Secondary outcomes (2)

Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort
The secondary efficacy endpoint is the subjective assessment of contact lens comfort associated with the stenfilcon A contact lens compared with the comfort associated with the ocufilcon B contact lens.
Subjective comfort assessment is related by the percent number of unique eyes that were reported to have no symptoms of discomfort (0=no symtoms reported) graded on a severity scale of the reported symptoms (0=no symptoms reported, 4=severe) that was experienced over the past month prior to baseline at the baseline visit (Baseline) and any symptoms of discomfort that was experienced since the previous study visit at each scheduled follow-up visit (Week 1, Week 2, Month 1, Month 2, Month 3).
Measured: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Evaluation of Average Lens Wearing Time - Average Daily Hours Worn
The secondary efficacy endpoint is the objective assessment of the lens average daily wearing times associated with the stenfilcon A compared with the lens average wearing times with the ocufilcon B contact lens. Objective average daily lens wearing time is measured in reported hours worn with the subject's habitual contact lenses recorded at baseline and after dispensing of study lenses recorded at Week 1, Week 2, Month 1, Month 2, Month 3.
Measured: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3

Timeline

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

Oct 2010Apr 2011

First posted16 May 2011 (estimated)
Study startOct 2010
Primary completionMar 2011
Study completionApr 2011

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: Parallel groups
Masking: None (open label)
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01354223
Sponsor's protocol ID: FC100239
Status last verified: Jul 2020
First submitted: 10 Jan 2011
Last updated: 29 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the CooperVision Stenfilcon A Soft Contact Lens for Daily Wear When Compared to the CooperVision Ocufilcon B Soft Contact Lens
ClinicalTrials.gov ID: NCT01354223
Acronym / sponsor ID: FC100239
Conditions: Myopia
Keywords: silicone hydrogel contact lens, SHCL, stenfilcon A, ocufilcon B, daily disposable, substantial equivalence, CooperVision ClearSight™ 1 Day SCL
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Mar 2011 (actual)
Study completion: Apr 2011 (actual)
First posted: 16 May 2011 (estimated)
Results: Posted 21 Mar 2014

Clinical summary

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

This study seeks to evaluate a new daily disposable contact lens compared to an existing daily disposable contact lens.

Detailed description

This study is designed to evaluate the stenfilcon A contact lens to demonstrate substantial equivalence to the Ocufilcon B for market release.

Study design

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

Arm	Type	Receives
stenfilcon A contact lens	Experimental	Device: stenfilcon A contact lensRandomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
ocufilcon B contact lens	Active comparator	Device: ocufilcon B contact lensRandomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode

Who may qualify

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

Key inclusion criteria (14 listed)

Be at least 18 years of age as of the date of evaluation for the study.
Have:
Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses on a daily basis for at least 8 hours per day for at least one month prior to participation in the study.
Possess wearable and visually functional eyeglasses.

Key exclusion criteria (24 listed)

Subjects may not be enrolled in this study if any of the following apply: The subject is/has:
Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes. NOTE: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.
Poor personal hygiene.
Any active participation in another clinical trial within 30 days prior to this study.
Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 months.

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 contact lensRandomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode	Device	stenfilcon A contact lens
ocufilcon B contact lensAlso: CooperVision ClearSight™ 1 DayDaily disposable contact lens worn in a daily wear, daily disposable mode	Device	ocufilcon B contact lens

Primary outcome

Objective Assessment: Ocular Response - Biomicroscopy
Time frame: Change from baseline visit and all follow-ups visits
The primary safety endpoint are the objective slit lamp findings associated with the stenfilcon A contact lenses compared with those same findings reported as associated with the ocufilcon B contact lenses. The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline (baseline visit) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit, month 2 visit combined).The average grade for unique eyes with findings greater than 0 (none) is compared.
Comparison of Objective Findings - Number of Adverse Events in Unique Eyes
Time frame: Any occurrence from dispensing to month 3 visit
The primary safety endpoint in this evaluation will be a comparison of the objective findings of the number of adverse events in unique eyes associated with the stenfilcon A contact lenses compared with those same findings as associated with ocufilcon B contact lenses. The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence after dispensing (dispensing visit) through end of month 3 visit (month 3 visit).
Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better
Time frame: week 1 visit, week 2 visit, month 1 visit, month 2 visit combined
The primary efficacy endpoint are the contact lens Snellen visual acuities (VA) of 20/25 VA or better associated with stenfilcon A compared with those same visual acuities associated with ocufilcon B. Snellen visual acuity (VA) examinations were performed at All Follow-up visits (week 1 visit, week 2 visit, month 1 visit, month 2 visit). The combined results of All Follow-up visits are compared.

2 secondary outcomes

Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Evaluation of Average Lens Wearing Time - Average Daily Hours Worn
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3

Results and safety

Results posted to the registry on 21 Mar 2014, 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 Contact Lens	60	57
Ocufilcon B Contact Lens	30	29

Primary outcome: Objective Assessment: Ocular Response - Biomicroscopy

Time frame: Change from baseline visit and all follow-ups visits. Mean (Full Range). Unit: units on a scale

Measure	Stenfilcon A Contact Lens n = 57	Ocufilcon B Contact Lens n = 29
Neovascularization, Baseline	1.00 (1 to 1)	1.00 (1 to 1)
Neovascularization, All Follow-up	1.00 (1 to 1)	1.10 (1 to 2)
Corneal Staining, Baseline	1.00 (1 to 1)	1.00 (1 to 1)
Corneal Staining, All Follow-up	1.09 (1 to 2)	1.18 (1 to 2)
Limbal Hyperemia, Baseline	1.00 (1 to 1)	1.00 (1 to 1)
Limbal Hyperemia, All Follow-up	1.03 (1 to 2)	1.05 (1 to 2)
Bulbar Hyperemia, Baseline	1.00 (1 to 1)	1.00 (1 to 1)
Bulbar Hyperemia, All Follow-up	1.05 (1 to 2)	1.02 (1 to 2)

Population analysed: Unique eyes are defined as each individual eye in the study and are only counted once for each of the visit groupings

Primary outcome: Comparison of Objective Findings - Number of Adverse Events in Unique Eyes

Time frame: Any occurrence from dispensing to month 3 visit. Number. Unit: number of adverse events

Measure	Stenfilcon A Contact Lens n = 57	Ocufilcon B Contact Lens n = 29
Value	7	1

Population analysed: Unique eyes are defined as each individual eye in the study.

Primary outcome: Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better

Time frame: week 1 visit, week 2 visit, month 1 visit, month 2 visit combined. Number. Unit: percentage of possible examinations

Measure	Stenfilcon A Contact Lens n = 57	Ocufilcon B Contact Lens n = 29
Value	99.3	100

Population analysed: For the completed study subjects, contact lens VA was collected at 562 of the possible 564 examinations (99.6%) for the Test cohort eyes and at 288 of the possible 288 examinations (100%) for the Control cohort eyes.

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 Contact Lens	0 of 60 (0%)	3 of 60 (5%)	Not reported
Ocufilcon B Contact Lens	0 of 30 (0%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Stephen Byrnes, OD principal investigator

Lee Rigel, OD principal investigator

Mary Jo Stiegemeier, OD principal investigator

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

Questions about this trial

What is this clinical trial studying?

A study testing stenfilcon A contact lens and ocufilcon B contact lens in people with Myopia, run by CooperVision, Inc. at 4 sites 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 14 inclusion and 24 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 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 21 Mar 2014). 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?

Objective Assessment: Ocular Response - Biomicroscopy (time frame: Change from baseline visit and all follow-ups visits). The study lists 3 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 NCT01354223.

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 29 Jul 2020.