MyopiaNCT01244516

Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses

A study testing galyfilcon A, BC 8.30, lotrafilcon B, BC 8.60 and comfilcon A, BC 8.60 in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 35 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 clinical performance of three silicone hydrogel contact lenses over a 2 week period. 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, BC 8.30, lotrafilcon B, BC 8.60 and comfilcon A, BC 8.60
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 540 participants
Where: 35 sitesUnited States
Study dates: 1 Sep 2010to 1 Nov 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

Be no less than 18 and no more than 39 years of age.
Sign Written Informed Consent and investigator to record this on Case Report Form.
Be willing and able to adhere to the instructions set out in the protocol.
Be an existing successful daily wear soft contact lens wearer. For the purposes of this study this means wearing lenses for at least 6 hours per day, 5 days per week for the last month.
No extended wear in the last 3 months.
Subjective refraction must result in a vertex corrected spherical contact lens prescription between -1.00 and -6.00 diopters.

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Have refractive astigmatism less than or equal to 1.00 diopters (D) in both eyes.
Achieve visual acuity of 6/9 (20/30) or better in each eye.
Require a visual correction in both eyes (no monovision allowed).
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: no amblyopia, no evidence of lid abnormality or infection (including blepharitis/meibomitis), no conjunctival abnormality or infection, no clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities), no other active ocular disease.

Who cannot join

Requires concurrent ocular medication.
Clinically significant corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
Clinically significant corneal staining
Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00 diopters).
Has had refractive surgery.
Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.

Show all 16Show fewer

Abnormal lacrimal secretions.
Pre-existing ocular irritation that would preclude contact lens fitting.
Keratoconus or other corneal irregularity.
Hard, hybrid or Rigid Gas Permeable lens wear in the previous 8 weeks.
Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Diabetic.
Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease [e.g., Human immunodeficiency virus (HIV)].
History of chronic eye disease (e.g. glaucoma or Age Related Macular Degeneration).
Pregnancy, lactating or planning a pregnancy at the time of enrollment.
Participation in any concurrent clinical trial or in last 30 days

Trial locations and contacts

35 sites in 1 country.

City, postcode or hospital

35 sites in 1 country

United States35 sites

Study site
Aventura, Florida, 33180
Study site
Bartlett, Tennessee, 38134
Study site
Bloomington, Illinois, 61701
Study site
Boston, Massachusetts, 02114
Study site
Brea, California, 92891
Study site
Brentwood, Tennessee, 37027
Study site
Bridgeport, Connecticut, 06610
Study site
Burlington, Vermont, 05401
Study site
Campbell, California, 95008
Study site
Chamberlain, South Dakota, 57325
Study site
Closter, New Jersey, 07624
Study site
Colorado Springs, Colorado, 80909
Study site
Cupertino, California, 95014
Study site
Independence, Missouri, 64055
Study site
Jacksonville, Florida, 32256
Study site
Kittanning, Pennsylvania, 16201
Study site
Memphis, Tennessee, 38119
Study site
Mishawaka, Indiana, 46545
Study site
Mission Viejo, California, 92691
Study site
New York, New York, 10001
Study site
North Olmsted, Ohio, 44070
Study site
Pittsburg, Kansas, 66763
Study site
Powell, Ohio, 43065
Study site
Raleigh, North Carolina, 27615
Study site
Raytown, Missouri, 64133
Study site
Roswell, Georgia, 30076
Study site
Salem, Virginia, 24153
Study site
Salt Lake City, Utah, 84106
Study site
Tallahassee, Florida, 32308
Study site
Tampa, Florida, 33625
Study site
Tyler, Texas, 75701
Study site
Tyler, Texas, 75703
Study site
Virginia Beach, Virginia, 23455
Study site
Warwick, Rhode Island, 02888
Study site
Winter Park, Florida, 32792

Other trials in United States

About this study

The purpose of this study is to compare the clinical performance of three silicone hydrogel contact lenses over a 2 week period.

Conditions: Myopia
Being tested: galyfilcon A, BC 8.30, lotrafilcon B, BC 8.60, comfilcon A, BC 8.60
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, BC 8.30Device
galyfilcon A, BC 8.30 soft contact lens
lotrafilcon B, BC 8.60Device
lotrafilcon B, BC 8.60 soft contact lens
comfilcon A, BC 8.60Device
comfilcon A, BC 8.60 soft contact lens

Study groups in NCT01244516
Study group	Role	What they receive
galyfilcon A	Other	Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study. Receives: Device: galyfilcon A, BC 8.30
lotrafilcon B	Other	Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study. Receives: Device: lotrafilcon B, BC 8.60
comfilcon A	Other	Subjects that were randomized to wear comfilcon A lens throughout the course of the study. Receives: Device: comfilcon A, BC 8.60

What is being measured

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

Overall Subjective Comfort
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 2 weeks of contact lens wear
Corneal Staining
Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence is evaluated.
Measured: after 2 weeks of contact lens wear

Secondary outcomes (1)

Overall Subjective Lens Handling
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 with a range of 0 to 120. Only galyficlon A and comfilcon A were evaluated.
Measured: after 2 weeks of contact lens wear

Timeline

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

1 Sep 20101 Nov 2010

First posted19 Nov 2010 (estimated)
Study start1 Sep 2010
Primary completion1 Nov 2010
Study completion1 Nov 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: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 540 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01244516
Sponsor's protocol ID: CR-201007
Status last verified: Apr 2018
First submitted: 17 Nov 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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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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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: Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses
ClinicalTrials.gov ID: NCT01244516
Acronym / sponsor ID: CR-201007
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 540 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 1 Sep 2010 (actual)
Primary completion: 1 Nov 2010 (actual)
Study completion: 1 Nov 2010 (actual)
First posted: 19 Nov 2010 (estimated)
Results: Posted 24 Jan 2012

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 clinical performance of three silicone hydrogel contact lenses over a 2 week period.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
galyfilcon A	Other	Device: galyfilcon A, BC 8.30Subjects that were randomized to receive the galyfilcon A lens with a base curve of 8.30 throughout the entire course of the study.
lotrafilcon B	Other	Device: lotrafilcon B, BC 8.60Subjects that were randomized to wear lotrafilcon B lens throughout the course of the study.
comfilcon A	Other	Device: comfilcon A, BC 8.60Subjects that were randomized to wear comfilcon A lens throughout the course of the study.

Who may qualify

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

Key inclusion criteria (10 listed)

Be no less than 18 and no more than 39 years of age.
Sign Written Informed Consent and investigator to record this on Case Report Form.
Be willing and able to adhere to the instructions set out in the protocol.
Be an existing successful daily wear soft contact lens wearer. For the purposes of this study this means wearing lenses for at least 6 hours per day, 5 days per week for the last month.
No extended wear in the last 3 months.

Key exclusion criteria (16 listed)

Requires concurrent ocular medication.
Clinically significant corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
Clinically significant corneal staining
Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00 diopters).
Has had refractive surgery.

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, BC 8.30galyfilcon A, BC 8.30 soft contact lens	Device	galyfilcon A
lotrafilcon B, BC 8.60lotrafilcon B, BC 8.60 soft contact lens	Device	lotrafilcon B
comfilcon A, BC 8.60comfilcon A, BC 8.60 soft contact lens	Device	comfilcon A

Primary outcome

Overall Subjective Comfort
Time frame: after 2 weeks of contact 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.
Corneal Staining
Time frame: after 2 weeks of contact lens wear
Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence is evaluated.

1 secondary outcome

Overall Subjective Lens Handling
Time frame: after 2 weeks of contact lens wear

Results and safety

Results posted to the registry on 24 Jan 2012, 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	170	166
Lotrafilcon B	177	171
Comfilcon A	173	170

Primary outcome: Overall Subjective Comfort

Time frame: after 2 weeks of contact lens wear. Least squares mean (Standard Error). Unit: CLUE score

Measure	Galyfilcon A n = 163	Lotrafilcon B n = 170	Comfilcon A n = 168
Value	51.7 (2.1)	51.3 (2.0)	51.3 (2.0)

Galyfilcon A vs Lotrafilcon B: Mean Difference (Final Values): 0.39 (97.4% CI -5.91 to 6.70), Mixed Models Analysis
Galyfilcon A vs Comfilcon A: Mean Difference (Final Values): 0.42 (97.4% CI -5.96 to 6.79), Mixed Models Analysis

Population analysed: Analysis is on those subjects who completed the study (n=501).

Primary outcome: Corneal Staining

Time frame: after 2 weeks of contact lens wear. Number. Unit: percentage of eyes

Measure	Galyfilcon A n = 163	Lotrafilcon B n = 170	Comfilcon A n = 168
No corneal staining	78.5	67.1	66.1
With corneal staining	21.5	32.9	33.9

Galyfilcon A vs Lotrafilcon B: Odds Ratio (OR): 1.66 (97.4% CI 1.14 to 2.44), Regression, Logistic
Galyfilcon A vs Comfilcon A: Odds Ratio (OR): 1.66 (97.4% CI 1.14 to 2.44), Regression, Logistic

Population analysed: Analysis is on those subjects who completed the study (n=501).

1 secondary outcome is 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	0 of 170 (0%)	0 of 170 (0%)	Not reported
Lotrafilcon B	0 of 177 (0%)	0 of 177 (0%)	Not reported
Comfilcon A	0 of 173 (0%)	0 of 173 (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.

35 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, BC 8.30, lotrafilcon B, BC 8.60 and comfilcon A, BC 8.60 in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 35 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 10 inclusion and 16 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 35 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 24 Jan 2012). 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?

Overall Subjective Comfort (time frame: after 2 weeks of contact lens wear). 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 NCT01244516.

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.