MyopiaNCT01386008

Evaluation of DW Silicone Hydrogel Lens Compared to DW Silicone Hydrogel Lens

A study testing senfilcon A contact lens and investigational enfilcon A in people with Myopia, run by CooperVision, Inc. at 2 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to evaluate the performance of the investigational CooperVision silicone hydrogel lens compared to a currently-marketed silicone hydrogel contact lens up to 30 days of daily lens wear. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: senfilcon A contact lens and investigational enfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 2 sitesin 2 countries
Study dates: May 2011to Jun 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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Be at least 18 years of age as of the date of evaluation for the study.
Not using any ocular medications
Have a self-reported full eye examination within 2 years.
Have:
read the Informed Consent
be given an explanation of the Informed Consent

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indicate understanding of the Informed Consent
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 0.75 diopter of refractive astigmatism in order to have the best spherical equivalent power of -6.50 or less.
Be willing to wear contact lenses in both eyes.
Have manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 (less than or equal to LogMAR 0.10) 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

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.
Any active participation in another one-day clinical trial within 7 days prior to this study or another dispensing 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 month.
Has a known sensitivity to ingredients used in the over the counter contact lens care approved for use in the study.
Previous refractive surgery/anterior segment surgery; or current or previous orthokeratology treatment or irregular cornea.
Is aphakic or pseudophakic.

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Unable to achieve a satisfactory fit with the lens designs used in the study
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 contradict contact lens wear or which would require the lenses to be removed during the day.
The presence of clinically anterior segment infection, inflammations or abnormalities; such as iritis; or any infection of the eye, lids, or associated structures.
A history of herpetic keratitis.
A known history of corneal hypoesthesia (reduced corneal sensitivity) or active corneal ulcer, corneal infiltrates or fungal infection.
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
Corneal edema or corneal staining ≥ grade 2
Neovascularization or ghost vessels > 1.0 mm in from the limbus
Giant papillary conjunctivitis (GPC) of > grade 2.
Seborrheic eczema, seborrheic conjunctivitis or blepharitis

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

United Kingdom1 site

University of Manchester
Manchester, M13 9PL

Other trials in United Kingdom

About this study

Conditions: Myopia
Being tested: senfilcon A contact lens, investigational enfilcon A
Medical subject headings: Myopia

What participants receive

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

senfilcon A contact lensDevice
senofilcon A spherical contact lens worn in a daily wear modality
investigational enfilcon ADevice
investigational enfilcon A, worn daily wear modality

Study groups in NCT01386008
Study group	Role	What they receive
enfilcon A + senofilcon A	Other	Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other Receives: Device: senfilcon A contact lens; Device: investigational enfilcon A

What is being measured

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

Subjective Comfort Preference - Participants Preference Response
Subjective responses of participants administered by questionnaire and measured on a linear scale (0-100) measured at each visit.
Measured: V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)
Ocular Health
Ocular health determined by biomicroscopy recorded on a severity scale (0-4) for change from baseline over 30 days.
Measured: Change from baseline over 30 days measured at V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)

Secondary outcomes (2)

Investigator Surface Preference
Investigator Surface Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L)
Measured: V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)
Investigator Fit Preference
Investigator Fit Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L)
Measured: V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)

Timeline

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

May 2011Jun 2011

First posted30 Jun 2011 (estimated)
Study startMay 2011
Primary completionJun 2011
Study completionJun 2011

Why it stopped: unexpected adverse events

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: Not applicable
Intervention model: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01386008
Sponsor's protocol ID: CV-10-50
Status last verified: Aug 2019
First submitted: 22 May 2011
Last updated: 4 Sep 2019
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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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of DW Silicone Hydrogel Lens Compared to DW Silicone Hydrogel Lens
ClinicalTrials.gov ID: NCT01386008
Acronym / sponsor ID: CV-10-50
Conditions: Myopia
Study type: Interventional
Recruitment status: TerminatedReason stopped: unexpected adverse events
Enrolment: 28 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 30 Jun 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: Double blind (participant, investigator)
Number of arms: 1

Arm	Type	Receives
enfilcon A + senofilcon A	Other	Device: senfilcon A contact lens, Device: investigational enfilcon ASimultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Be at least 18 years of age as of the date of evaluation for the study.
Not using any ocular medications
Have a self-reported full eye examination within 2 years.
Have:
Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.

Key exclusion criteria (21 listed)

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.
Any active participation in another one-day clinical trial within 7 days prior to this study or another dispensing 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 month.
Has a known sensitivity to ingredients used in the over the counter contact lens care approved for use in the study.
Previous refractive surgery/anterior segment surgery; or current or previous orthokeratology treatment or irregular cornea.

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
senfilcon A contact lenssenofilcon A spherical contact lens worn in a daily wear modality	Device	enfilcon A + senofilcon A
investigational enfilcon Ainvestigational enfilcon A, worn daily wear modality	Device	enfilcon A + senofilcon A

Primary outcome

Subjective Comfort Preference - Participants Preference Response
Time frame: V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)
Subjective responses of participants administered by questionnaire and measured on a linear scale (0-100) measured at each visit.
Ocular Health
Time frame: Change from baseline over 30 days measured at V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)
Ocular health determined by biomicroscopy recorded on a severity scale (0-4) for change from baseline over 30 days.

2 secondary outcomes

Investigator Surface Preference
Time frame: V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)
Investigator Fit Preference
Time frame: V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)

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
Overall Study Group	20	0

Primary outcome: Subjective Comfort Preference - Participants Preference Response

Time frame: V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30). Number. Unit: participants

Measure	Enfilcon A + Senofilcon A n = 20
Preferred Test lens Visit 1	7
No Preference Visit 1	8
Preferred Control Lens Visit 1	5
Preferred Test lens Visit 2	0
No Preference Visit 2	1
Preferred Control lens Visit 2	0

Population analysed: Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.

Primary outcome: Ocular Health

Time frame: Change from baseline over 30 days measured at V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)

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
Overall Study Group	0 of 20 (0%)	3 of 20 (15%)	Not reported

Limitations and caveats (from the sponsor): Incomplete data sets / Data not analyzed / Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
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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
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
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Active, not recruiting
Effect of IOP Lowering on Progressive HM
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Recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing senfilcon A contact lens and investigational enfilcon A in people with Myopia, 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 16 inclusion and 21 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: stopped early, as of the sponsor's last update on 4 Sep 2019. 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, United Kingdom. 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?

Subjective Comfort Preference - Participants Preference Response (time frame: V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)). The study lists 2 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 NCT01386008.

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 4 Sep 2019.