MyopiaNCT00717249

Vistakon Investigational Contact Lenses Worn for Daily Wear

A study testing galyfilcon A with a silver additive in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 20 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 compares the performance of an investigational contact lens to a currently marketed 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?: galyfilcon A with a silver additive
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 529 participants
Where: 20 sitesUnited States
Study dates: Aug 2007to Apr 2008
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

The subject must be at least 18 years of age.
Both males and females may be enrolled.
The subject must read, understand, and sign for themselves the STATEMENT OF INFORMED CONSENT and be provided with a copy of the form.
The subject is able and willing to wear soft contact lenses on a daily basis for a six month duration.

Who cannot join

The subject must be free of Grade 2 or greater slit lamp findings (edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, and other ocular abnormality), which would contraindicate contact lens wear.
Any active ocular (i.e. corneal infiltrates, conjunctiva, lids, and intraocular) infection or inflammation of an allergic, bacterial, or viral etiology.
Entropion, ectropion, chalazia, recurrent styes, glaucoma or glaucoma suspect, history of recurrent corneal erosions and aphakia.
The following medications are prohibited (at lease one week prior to enrollment): oral retinoid isoretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g. antihistamines (e.g. Seldane, Chlor-Trimeton, and Benadryl), and ophthalmic antihistamic Beta-adrenergic blockers (e.g. Propranolol, Timolol, and Practolol), systemic steroids, and and prescribed or OTC ocular medication. Any prescription or PTC medications or preparations containing silver.
Moderate or above corneal distortion by keratometry.
Known allergy to silver, silver ions, or silver containing compounds.

Show all 22Show fewer

Abnormal discoloration of the cornea and/or conjunctiva.
Routine exposure to silver, silver ions, or silver containing compounds.
The subject must be free of systemic diseases which may interfere with contact lens wear: diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases (e.g. AIDS)
Free of systemic and infectious diseases: hepatitis and tuberculosis.
Subjects must be HIV negative.
The subject must not be currently be pregnant or lactating (Subject becoming pregnant during the study will be discontinued).
The subject's eyes must be best corrected to a visual acuity of 20/30 or better in each eye.
The subject must not have more than 1.00D of refractive astigmatism in either eye.
The subject's distance spherical contact lens prescription must be between -1.00D and -6.00D.
The subject must not be monovision corrected.
The subject must have no history of solution reaction to Opti-free RepleniSH MPDS-No Rub Solution.
The subject must not have any previous history or signs of a contact lens related corneal inflammatory event (i.e. past peripheral ulcers or round peripheral scars)
The subject must not have participated in a device or pharmaceutical clinical trial within 30 days prior to study enrollment.
The subject must not have had an eye injury within 8 weeks prior to study enrollment.
The subject must not have had previous eye surgery.
The subject must be successfully trial fitted with the study contact lenses.

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Premier Vision
Amarillo, Texas, 79119
Drs. Quinn, Quinn and Associates
Athens, Ohio, 45701
Eyecare Associates
Bloomington, Illinois, 61701
Dr. Michael H. Greenburg, Inc.
Chagrin Falls, Ohio, 44023
Central Ohio Eyecare
Columbus, Ohio, 43202
Cole, Cole, and Krohn
Fresno, California, 93704
Baymeadows Vision Center
Jacksonville, Florida, 32256
Spectrum Eyecare
Jamestown, New York, 14750
Snowy Range Vision Center
Laramie, Wyoming, 82070
Fukai and Associates
Louisville, Colorado, 80027
Dr. James R. Dugue Family Optometrist
Mission Viejo, California, 92691
West Hills Vision Center
Moon Township, Pennsylvania, 15108
Advantage Eyecare Associates, LLC
Neodesha, Kansas, 66757
James W. Kershaw OD, Inc.
North Olmsted, Ohio, 44070
William J. Bogus OD
Salt Lake City, Utah, 84106
Nittany Eye Associates
State College, Pennsylvania, 16801
The Eye Speciliasts, Ltd
Virginia Beach, Virginia, 23455
InSight Eyecare
Warrensburg, Missouri, 64093
Dr. David W. Ferris and Associates
Warwick, Rhode Island, 02886
Research Across America
Wyomissing, Pennsylvania, 19610

Other trials in United States

About this study

This study compares the performance of an investigational contact lens to a currently marketed lens.

Conditions: Myopia
Being tested: galyifilcon A control lens, galyfilcon A with a silver additive
Medical subject headings: Myopia

What participants receive

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

galyifilcon A control lensDevice
Also called ACUVUE Advance with Hydraclear
Marketed daily wear contact lens
galyfilcon A with a silver additiveDevice
Investigational daily wear contact lens

Study groups in NCT00717249
Study group	Role	What they receive
Test Lens	Experimental	galyfilcon A contact lens with a silver additive Receives: Device: galyfilcon A with a silver additive
Control Lens	Active comparator	galyfilcon A control contact lens Receives: Device: galyifilcon A control lens

What is being measured

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

Slit Lamp Findings
Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded using a 5- point scale. (Grade 0, 1, 2, 3 and 4). The data was dichotomized by creating 2 groups. Eyes with Grade 3 or Grade 4; eyes with Grade 2 or lower. The number of eyes with Grade 3 or Grade 4 was reported.
Measured: 6 months
Subject Reported Symptoms
Subjects were asked "Have you experienced any symptoms or problems since your last visit?" at each visit and responded 'yes' or 'no' for each eye; at each visit(baseline, 2-, 4-, 12- and 26- week follow-up evaluations). If a subject responded 'yes' then the symptoms was classified into one of the four categories, "Dryness", "Other", "Cloudy/ Blurry / Hazy", "Irritation / Discomfort". The percentage of each response across all visits was reported.
Measured: 6 months
Visual Acuity
Binocular LogMAR Visual Acuity was taken under low luminance and high contrast conditions using ETDRS acuity charts.
Measured: 6 months
Average Contact Lens Wear Time
The Contact lens wear time for the study contact lenses was collected for each subject. The average wear time for each contact lens was reported.
Measured: 6 Months

Timeline

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

Aug 2007Apr 2008

First posted17 Jul 2008 (estimated)
Study startAug 2007
Primary completionApr 2008
Study completionApr 2008

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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 529 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00717249
Sponsor's protocol ID: CR-1513
Status last verified: Apr 2016
First submitted: 15 Jul 2008
Last updated: 26 May 2016
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

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vistakon Investigational Contact Lenses Worn for Daily Wear
ClinicalTrials.gov ID: NCT00717249
Acronym / sponsor ID: CR-1513
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 529 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2007
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 17 Jul 2008 (estimated)
Results: Posted 26 May 2016

Clinical summary

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

This study compares the performance of an investigational contact lens to a currently marketed lens.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Test Lens	Experimental	Device: galyfilcon A with a silver additivegalyfilcon A contact lens with a silver additive
Control Lens	Active comparator	Device: galyifilcon A control lensgalyfilcon A control contact lens

Who may qualify

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

Key inclusion criteria (4 listed)

The subject must be at least 18 years of age.
Both males and females may be enrolled.
The subject must read, understand, and sign for themselves the STATEMENT OF INFORMED CONSENT and be provided with a copy of the form.
The subject is able and willing to wear soft contact lenses on a daily basis for a six month duration.

Key exclusion criteria (22 listed)

The subject must be free of Grade 2 or greater slit lamp findings (edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, and other ocular abnormality), which would contraindicate contact lens wear.
Any active ocular (i.e. corneal infiltrates, conjunctiva, lids, and intraocular) infection or inflammation of an allergic, bacterial, or viral etiology.
Entropion, ectropion, chalazia, recurrent styes, glaucoma or glaucoma suspect, history of recurrent corneal erosions and aphakia.
The following medications are prohibited (at lease one week prior to enrollment): oral retinoid isoretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g. antihistamines (e.g. Seldane, Chlor-Trimeton, and Benadryl), and ophthalmic antihistamic Beta-adrenergic blockers (e.g. Propranolol, Timolol, and Practolol), systemic steroids, and and prescribed or OTC ocular medication. Any prescription or PTC medications or preparations containing silver.
Moderate or above corneal distortion by keratometry.

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
galyifilcon A control lensAlso: ACUVUE Advance with HydraclearMarketed daily wear contact lens	Device	Control Lens
galyfilcon A with a silver additiveInvestigational daily wear contact lens	Device	Test Lens

Primary outcome

Slit Lamp Findings
Time frame: 6 months
Each subjects' eye was examined using a bio-microscope. Slit lamp findings were graded using a 5- point scale. (Grade 0, 1, 2, 3 and 4). The data was dichotomized by creating 2 groups. Eyes with Grade 3 or Grade 4; eyes with Grade 2 or lower. The number of eyes with Grade 3 or Grade 4 was reported.
Subject Reported Symptoms
Time frame: 6 months
Subjects were asked "Have you experienced any symptoms or problems since your last visit?" at each visit and responded 'yes' or 'no' for each eye; at each visit(baseline, 2-, 4-, 12- and 26- week follow-up evaluations). If a subject responded 'yes' then the symptoms was classified into one of the four categories, "Dryness", "Other", "Cloudy/ Blurry / Hazy", "Irritation / Discomfort". The percentage of each response across all visits was reported.
Visual Acuity
Time frame: 6 months
Binocular LogMAR Visual Acuity was taken under low luminance and high contrast conditions using ETDRS acuity charts.
Average Contact Lens Wear Time
Time frame: 6 Months
The Contact lens wear time for the study contact lenses was collected for each subject. The average wear time for each contact lens was reported.

Results and safety

Results posted to the registry on 26 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Galyfilcon A w/ Silver	326	304
Galyfilcon A	165	150

Primary outcome: Slit Lamp Findings

Time frame: 6 months. Number. Unit: Number of Subject Eyes

Measure	Galyfilcon A w/ Silver n = 304	Galyfilcon A n = 150
Value	7	2

Population analysed: The analysis population consists of subjects that completed all study visits without a major protocol deviation.

Primary outcome: Subject Reported Symptoms

Time frame: 6 months. Number. Unit: Percentage of Observations

Measure	Galyfilcon A w/ Silver n = 304	Galyfilcon A n = 150
Dryness	9.9	6.3
Other	4.9	4.0
Cloudy/ Blurry / Hazy	2.8	2.5
Irritation / Discomfort	2.8	2.3

Population analysed: The analysis population consists of subjects that completed all study visits without a major protocol deviation.

Primary outcome: Visual Acuity

Time frame: 6 months. Mean (Standard Deviation). Unit: LogMAR

Measure	Galyfilcon A w/ Silver n = 304	Galyfilcon A n = 150
Value	0.004 (0.0891)	-0.009 (0.0866)

Population analysed: The analysis population consists of subjects that completed all study visits without a major protocol deviation.

Primary outcome: Average Contact Lens Wear Time

Time frame: 6 Months. Mean (Full Range). Unit: time in hours

Measure	Galyfilcon A w/ Silver n = 304	Galyfilcon A n = 150
Value	14.0 (13.92 to 14.03)	14.0 (13.95 to 14.04)

Population analysed: The analysis population consists of subjects that completed all study visits without a major protocol deviation.

Adverse events

Time frame: Throughout the duration of the study. Approximately 6 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Galyfilcon A w/ Silver	0 of 326 (0%)	0 of 326 (0%)	Not reported
Galyfilcon A	1 of 165 (0.6%)	0 of 165 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
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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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.

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

Questions about this trial

What is this clinical trial studying?

A study testing galyfilcon A with a silver additive in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 20 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 4 inclusion and 22 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 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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 26 May 2016). 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?

Slit Lamp Findings (time frame: 6 months). The study lists 4 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 NCT00717249.

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 26 May 2016.