MyopiaNCT01192542

Pilot Evaluation of a New Galyfilcon A Lens Prototype and Enfilcon A Lens

A study testing galyfilcon A prototype lens and enfilcon A lens in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 3 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

The purpose of this study is to compare the visual acuity, limbal and bulbar redness of the new galyfilcon A prototype lenses against Avaira® lenses when worn as daily wear for seven (7) days. Read more about this study

Who is it for?: Ages 18 to 39 years
Conditions the study is for: Myopia
What is being tested?: galyfilcon A prototype lens and enfilcon A lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 3 sitesUnited States
Study dates: Aug 2010to Sep 2010
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 to 39 years
All sexes
No healthy volunteers
Adult

Who may be able to join

The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study.
The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
Any cylinder power must be ≤ -0.75D.
The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
The subject must read and sign the Statement of Informed Consent.
The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Who cannot join

Ocular or systemic allergies or disease which might interfere with contact lens wear.
Systemic disease or use of medication which might interfere with contact lens wear.
Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
Any ocular infection.
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

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Pregnancy or lactation.
Diabetes.
Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
Habitual contact lens type is toric, multifocal, or is worn as extended wear.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Study site
Fincastle, Virginia
Study site
Pismo Beach, California
Study site
Warwick, Rhode Island

Other trials in United States

About this study

Official title: Dispensing Evaluation of a New Galyfilcon A Prototype and Avaira Lenses

The purpose of this study is to compare the visual acuity, limbal and bulbar redness of the new galyfilcon A prototype lenses against Avaira® lenses when worn as daily wear for seven (7) days.

Conditions: Myopia
Being tested: galyfilcon A prototype lens, enfilcon A lens
Medical subject headings: Myopia

What participants receive

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

galyfilcon A prototype lensDevice
Prototype silicone hydrogel contact lens
enfilcon A lensDevice
Also called Avaira® contact lens
Marketed silicone hydrogel contact lens

Study groups in NCT01192542
Study group	Role	What they receive
galyfilcon A prototype lens/enfilcon A lens	Other	galyfilcon A prototype contact lens worn daily for 6-8 days first then enfilcon A contact lens worn daily for 6-8 days second. Receives: Device: galyfilcon A prototype lens; Device: enfilcon A lens
enfilcon A lens/galyfilcon A prototype lens	Other	enfilcon A contact lens worn daily for 6-8 days first then galyfilcon A prototype contact lens worn daily for 6-8 days second. Receives: Device: galyfilcon A prototype lens; Device: enfilcon A lens

What is being measured

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

Monocular Visual Acuity Assessment
Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale.
Measured: Post lens insertion (baseline)
Binocular Visual Acuity
Snellen binocular visual acuity assessed by the Investigator and was converted to the LogMAR scale. A value <0 implies clinically positive results, a value >0 implies clinically negative results
Measured: Post lens insertion (baseline)

Secondary outcomes (2)

Limbal Redness of Grade 3 or Above
Limbal redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with limbal redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting.
Measured: After 6-8 days of lens wear
Bulbar Redness of Grade 3 or Above
Bulbar redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with bulbar redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting.
Measured: After 6-8 days of lens wear

Timeline

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

Aug 2010Sep 2010

First posted1 Sep 2010 (estimated)
Study startAug 2010
Primary completionSep 2010

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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01192542
Sponsor's protocol ID: CR-1636BE
Status last verified: May 2016
First submitted: 30 Aug 2010
Last updated: 19 Jun 2018
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 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dispensing Evaluation of a New Galyfilcon A Prototype and Avaira Lenses
ClinicalTrials.gov ID: NCT01192542
Acronym / sponsor ID: CR-1636BE
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Sep 2010 (actual)
First posted: 1 Sep 2010 (estimated)
Results: Posted 17 Jan 2014

Clinical summary

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

The purpose of this study is to compare the visual acuity, limbal and bulbar redness of the new galyfilcon A prototype lenses against Avaira® lenses when worn as daily wear for seven (7) days.

Study design

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

Arm	Type	Receives
galyfilcon A prototype lens/enfilcon A lens	Other	Device: galyfilcon A prototype lens, Device: enfilcon A lensgalyfilcon A prototype contact lens worn daily for 6-8 days first then enfilcon A contact lens worn daily for 6-8 days second.
enfilcon A lens/galyfilcon A prototype lens	Other	Device: galyfilcon A prototype lens, Device: enfilcon A lensenfilcon A contact lens worn daily for 6-8 days first then galyfilcon A prototype contact lens worn daily for 6-8 days second.

Who may qualify

Ages: 18 to 39 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study.
The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
Any cylinder power must be ≤ -0.75D.
The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
The subject must read and sign the Statement of Informed Consent.

Key exclusion criteria (10 listed)

Ocular or systemic allergies or disease which might interfere with contact lens wear.
Systemic disease or use of medication which might interfere with contact lens wear.
Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
Any ocular infection.

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
galyfilcon A prototype lensPrototype silicone hydrogel contact lens	Device	enfilcon A lens/galyfilcon A prototype lens, galyfilcon A prototype lens/enfilcon A lens
enfilcon A lensAlso: Avaira® contact lensMarketed silicone hydrogel contact lens	Device	enfilcon A lens/galyfilcon A prototype lens, galyfilcon A prototype lens/enfilcon A lens

Primary outcome

Monocular Visual Acuity Assessment
Time frame: Post lens insertion (baseline)
Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale.
Binocular Visual Acuity
Time frame: Post lens insertion (baseline)
Snellen binocular visual acuity assessed by the Investigator and was converted to the LogMAR scale. A value <0 implies clinically positive results, a value >0 implies clinically negative results

2 secondary outcomes

Limbal Redness of Grade 3 or Above
Time frame: After 6-8 days of lens wear
Bulbar Redness of Grade 3 or Above
Time frame: After 6-8 days of lens wear

Results and safety

Results posted to the registry on 17 Jan 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
Galyfilcon A Prototype Lens/Enfilcon A Lens	18	18
Enfilcon A Lens/Galyfilcon A Prototype Lens	20	20

Primary outcome: Monocular Visual Acuity Assessment

Time frame: Post lens insertion (baseline). Least squares mean (Standard Error). Unit: logMAR

Measure	Galyfilcon A Prototype Lens n = 38	Enfilcon A Lens n = 38
Value	-0.05 (0.0317)	-0.04 (0.0317)

Galyfilcon A Prototype Lens vs Enfilcon A Lens: Least-square mean difference: -0.009 (95% CI -0.022 to 0.003), Mixed Models Analysis

Population analysed: Analysis was conducted on subjects who were enrolled, randomized, and successfully completed the study.

Primary outcome: Binocular Visual Acuity

Time frame: Post lens insertion (baseline). Least squares mean (Standard Error). Unit: LogMAR

Measure	Galyfilcon A Prototype Lens n = 38	Enfilcon A Lens n = 38
Value	-0.08 (0.032)	-0.08 (0.032)

Galyfilcon A Prototype Lens vs Enfilcon A Lens: Least-square mean difference: 0 (95% CI -0.018 to 0.018), Mixed Models Analysis

Population analysed: Analysis was conducted on subjects who enrolled, were randomized, and successfully complete the study per protocol.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were recorded when the subjects were exposed to the Investigational lenses.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Subjects	0 of 38 (0%)	0 of 38 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
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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Active, not recruiting
Effect of IOP Lowering on Progressive HM
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Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
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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.

3 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 prototype lens and enfilcon A lens in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 3 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 6 inclusion and 10 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 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 17 Jan 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?

Monocular Visual Acuity Assessment (time frame: Post lens insertion (baseline)). 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 NCT01192542.

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 Jun 2018.