MyopiaNCT01180985

Dispensing Evaluation of a Galyfilcon A Prototype Lens and a Marketed Contact Lens

A study testing galyfilcon A prototype lens and comfilcon A in people with Myopia, run by Johnson & Johnson Vision Care, 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

The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens. 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 comfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 4 sitesUnited States
Study dates: 1 Jun 2010to 1 Jul 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 the 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

4 sites in 1 country.

United States4 sites

Study site
Fincastle, Virginia
Study site
Jacksonville, Florida
Study site
Orlando, Florida
Study site
Salem, Virginia

Other trials in United States

About this study

The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.

Conditions: Myopia
Being tested: galyfilcon A prototype lens, comfilcon A
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
silicone hydrogel contact lens
comfilcon ADevice
Also called Biofinity® contact lens
silicone hydrogel contact lens

Study groups in NCT01180985
Study group	Role	What they receive
galyfilcon A prototype/comfilcon A	Other	The galyfilcon A prototype lenses are worn during first period and comfilcon A lenses worn during second period. Each period consists of daily lens wear for one week. Receives: Device: galyfilcon A prototype lens; Device: comfilcon A
comfilcon A/galyfilcon A prototype	Other	The comfilcon A lenses are worn during first period and galyfilcon A prototype lenses worn during second period. Each period consists of daily lens wear for one week. Receives: Device: galyfilcon A prototype lens; Device: comfilcon A

What is being measured

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

Visual Acuity Monocular
Snellen monocular visual acuity measurement was measured in both eyes that wore lenses for one week and came in for the evaluation with an inserted lens.
Measured: after 7 +/- 1 days of lens wear
Visual Acuity Binocular
Snellen binocular visual acuity measurement
Measured: after 7 +/- 1 days of lens wear
Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.
The contract Lens Experience (CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Measured: after 7 +/-1 days of lens wear
Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire.
Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Measured: after 7 +/- 1 days of lens wear

Secondary outcomes (3)

Limbal Redness
Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Measured: after 7 days of lens wear
Bulbar Redness
Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Measured: after 7 days of lens wear
Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.
Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Measured: 10 minutes after lens insertion at time of initial lens fitting

Timeline

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

1 Jun 20101 Jul 2010

First posted13 Aug 2010 (estimated)
Study start1 Jun 2010
Primary completion1 Jul 2010
Study completion1 Jul 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01180985
Sponsor's protocol ID: CR-1636BD
Status last verified: Aug 2017
First submitted: 11 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 Galyfilcon A Prototype Lens and a Marketed Contact Lens
ClinicalTrials.gov ID: NCT01180985
Acronym / sponsor ID: CR-1636BD
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 1 Jun 2010 (actual)
Primary completion: 1 Jul 2010 (actual)
Study completion: 1 Jul 2010 (actual)
First posted: 13 Aug 2010 (estimated)
Results: Posted 5 Feb 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 visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.

Study design

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

Arm	Type	Receives
galyfilcon A prototype/comfilcon A	Other	Device: galyfilcon A prototype lens, Device: comfilcon AThe galyfilcon A prototype lenses are worn during first period and comfilcon A lenses worn during second period. Each period consists of daily lens wear for one week.
comfilcon A/galyfilcon A prototype	Other	Device: galyfilcon A prototype lens, Device: comfilcon AThe comfilcon A lenses are worn during first period and galyfilcon A prototype lenses worn during second period. Each period consists of daily lens wear for one week.

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 lenssilicone hydrogel contact lens	Device	comfilcon A/galyfilcon A prototype, galyfilcon A prototype/comfilcon A
comfilcon AAlso: Biofinity® contact lenssilicone hydrogel contact lens	Device	comfilcon A/galyfilcon A prototype, galyfilcon A prototype/comfilcon A

Primary outcome

Visual Acuity Monocular
Time frame: after 7 +/- 1 days of lens wear
Snellen monocular visual acuity measurement was measured in both eyes that wore lenses for one week and came in for the evaluation with an inserted lens.
Visual Acuity Binocular
Time frame: after 7 +/- 1 days of lens wear
Snellen binocular visual acuity measurement
Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.
Time frame: after 7 +/-1 days of lens wear
The contract Lens Experience (CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.
Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire.
Time frame: after 7 +/- 1 days of lens wear
Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.

3 secondary outcomes

Limbal Redness
Time frame: after 7 days of lens wear
Bulbar Redness
Time frame: after 7 days of lens wear
Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.
Time frame: 10 minutes after lens insertion at time of initial lens fitting

Results and safety

Results posted to the registry on 5 Feb 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 (Test)/Comfilcon A (Control)	27	27
Comfilcon A (Control)/Galyfilcon A (Test)	26	26

Primary outcome: Visual Acuity Monocular

Time frame: after 7 +/- 1 days of lens wear. Number. Unit: eyes

Measure	Comfilcon A Lens (Control) n = 52	Galyfilcon A Lens (Test) n = 52
20/15 monocular	53	49
20/20 monocular	49	48
20/25 monocular	2	4
20/30 monocular	0	3

Population analysed: Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.

Primary outcome: Visual Acuity Binocular

Time frame: after 7 +/- 1 days of lens wear. Number. Unit: participants

Measure	Comfilcon A Lens (Control) n = 52	Galyfilcon A Lens (Test) n = 52
20/10 binocular	0	1
20/15 binocular	31	29
20/20 binocular	21	20
20/25 binocular	0	1
20/30 binocular	0	1

Population analysed: Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.

Primary outcome: Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.

Time frame: after 7 +/-1 days of lens wear. Least squares mean (Standard Error). Unit: CLUE score

Measure	Comfilcon A Lens (Control) n = 50	Galyfilcon A Lens (Test) n = 50
Value	57.72 (4.47)	67.06 (4.50)

Population analysed: Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.

Primary outcome: Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire.

Time frame: after 7 +/- 1 days of lens wear. Least squares mean (Standard Error). Unit: CLUE score

Measure	Comfilcon A Lens (Control) n = 50	Galyfilcon A Lens (Test) n = 50
Value	62.75 (2.83)	59.98 (2.81)

Population analysed: Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.

3 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
Galyfilcon A Prototype/Comfilcon A	0 of 53 (0%)	0 of 53 (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.

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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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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.

4 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 comfilcon A in people with Myopia, run by Johnson & Johnson Vision Care, 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 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 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 5 Feb 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?

Visual Acuity Monocular (time frame: after 7 +/- 1 days of lens wear). 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 NCT01180985.

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.