MyopiaNCT00975585

Clinical Performance Comparison of Two Contact Lenses

A study testing senofilcon A and lotrafilcon B in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 25 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 two contact lenses. Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Myopia
What is being tested?: senofilcon A and lotrafilcon B
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 379 participants
Where: 25 sitesUnited States
Study dates: 1 Aug 2009to 1 Oct 2009
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 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Existing daily soft lens wearer.
Require a distance visual correction in both eyes.
Have a contact lens spherical distance refraction between -1.00D and -6.00D.
Have refractive astigmatism less than or equal to 1.00D in both eyes.
Achieve 20/30 or better corrected distance acuity.
Have normal eyes with no evidence of abnormality or disease.

Who cannot join

Requires presbyopic correction.
Requires ocular medications.
Grade 3 or 4 ocular abnormalities.
Grade 3 corneal staining in more than one region.
Has had refractive surgery.
Any other injury or ocular surgery within 8 weeks prior to study enrollment.

Show all 17Show fewer

Has abnormal lacrimal secretions.
Pre-existing ocular irritation that would preclude contact lens fitting.
Has keratoconus or other corneal irregularity.
Polymethyl methacrylate (PMMA), Hybrid or Rigid Gas Permeable (RGP) wear in the previous 8 weeks.
Wears habitual contact lenses that are toric, multifocal or worn extended wear.
Any systemic illness which would contraindicate lens wear or the medical treatment of would affect vision or successful lens wear.
Diabetic.
Infectious or immunosuppressive disease.
History of chronic eye disease (e.g glaucoma or age related macular degeneration).
Pregnancy, lactation or planning pregnancy at time of enrollment.
Participation in any concurrent clinical trial or in another trial in the last 30 days.

Trial locations and contacts

25 sites in 1 country.

City, postcode or hospital

25 sites in 1 country

United States25 sites

Study site
Bartlett, Tennessee, 38134
Study site
Blue Springs, Missouri, 64015
Study site
Boston, Massachusetts, 02114
Study site
Brentwood, Tennessee, 37027
Study site
Burlington, Vermont, 05401
Study site
Cambridge, Massachusetts, 02140
Study site
Campbell, California, 95008
Study site
Chagrin Falls, Ohio, 44023
Study site
Chamberlain, South Dakota, 57325
Study site
Colorado Springs, Colorado, 80909
Study site
Hot Springs, South Dakota, 57747
Study site
Jacksonville, Florida, 32205
Study site
Jacksonville, Florida, 32256
Study site
Memphis, Tennessee, 38119
Study site
Miami, Florida, 33155
Study site
New York, New York, 10001
Study site
North Little Rock, Arkansas, 72116
Study site
North Olmsted, Ohio, 44070
Study site
Roswell, Georgia, 30076
Study site
State College, Pennsylvania, 16801
Study site
Tyler, Texas, 757703
Study site
Warren, Ohio, 44484
Study site
Warwick, Rhode Island, 02888
Study site
West Allis, Wisconsin, 53227
Study site
Winter Park, Florida, 32792

Other trials in United States

About this study

Official title: Clinical Evaluation of Two Silicone Hydrogel Frequent Replacement Contact Lenses

The purpose of this study is to compare the clinical performance of two contact lenses.

Conditions: Myopia
Being tested: senofilcon A, lotrafilcon B
Medical subject headings: Myopia

What participants receive

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

senofilcon ADevice
soft contact lens, 2-week replacement indicated
lotrafilcon BDevice
soft contact lens with a 4-week replacement indicated.

Study groups in NCT00975585
Study group	Role	What they receive
senofilcon A both eyes	Active comparator	soft contact lens worn daily for 2 weeks, with a 2-week replacement regimen. Receives: Device: senofilcon A
lotrafilcon B both eyes	Active comparator	soft contact lens worn daily for 4 weeks, with a 4-week replacement regimen Receives: Device: lotrafilcon B

What is being measured

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

Average Corneal Staining
The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe.
Measured: 2 weeks
Visual Acuity
Visual acuity was assessed by the investigator using the Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR). logMAR ideal is 0.0 and represents 20/20 Snellen visual acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Measured: 2 weeks
Overall Comfort
After two weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (senofilcon A and lotrafilcon B) using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Measured: 2 weeks
Overall Comfort
After four weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (lotrafilcon B)using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Measured: 2 weeks and 4 weeks

Secondary outcomes (3)

Limbal Redness
The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Measured: 2 weeks
Bulbar Redness
The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe
Measured: 2 weeks
Symptoms of Dryness
Subjects responded to a phone survey question regarding the frequency of the sensation of dryness while wearing the study contact lenses using the following scale: 1=Extreme, 2=Moderate, 3=Slight, 4=None
Measured: 2 weeks

Timeline

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

1 Aug 20091 Oct 2009

First posted11 Sep 2009 (estimated)
Study start1 Aug 2009
Primary completion1 Oct 2009
Study completion1 Oct 2009

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: 379 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00975585
Sponsor's protocol ID: CR-0907
Other IDs: PHNX-518
Status last verified: Aug 2017
First submitted: 10 Sep 2009
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: Clinical Evaluation of Two Silicone Hydrogel Frequent Replacement Contact Lenses
ClinicalTrials.gov ID: NCT00975585
Acronym / sponsor ID: CR-0907
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 379 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Collaborators: Visioncare Research Ltd.
Study start: 1 Aug 2009 (actual)
Primary completion: 1 Oct 2009 (actual)
Study completion: 1 Oct 2009 (actual)
First posted: 11 Sep 2009 (estimated)
Results: Posted 22 Mar 2011

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 two contact lenses.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
senofilcon A both eyes	Active comparator	Device: senofilcon Asoft contact lens worn daily for 2 weeks, with a 2-week replacement regimen.
lotrafilcon B both eyes	Active comparator	Device: lotrafilcon Bsoft contact lens worn daily for 4 weeks, with a 4-week replacement regimen

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Existing daily soft lens wearer.
Require a distance visual correction in both eyes.
Have a contact lens spherical distance refraction between -1.00D and -6.00D.
Have refractive astigmatism less than or equal to 1.00D in both eyes.
Achieve 20/30 or better corrected distance acuity.

Key exclusion criteria (17 listed)

Requires presbyopic correction.
Requires ocular medications.
Grade 3 or 4 ocular abnormalities.
Grade 3 corneal staining in more than one region.
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
senofilcon Asoft contact lens, 2-week replacement indicated	Device	senofilcon A both eyes
lotrafilcon Bsoft contact lens with a 4-week replacement indicated.	Device	lotrafilcon B both eyes

Primary outcome

Average Corneal Staining
Time frame: 2 weeks
The overall score is the average of the total scores of each of five regions of the cornea. The minimum average score is 0 and the maximum average score is 3. Corneal surface abnormality as indicated by the severity of staining over five regions of the cornea (central, superior, inferior, nasal and temporal) was assessed by the investigator using the following scale: 0=none, 1=slight, 2=moderate, 3=severe.
Visual Acuity
Time frame: 2 weeks
Visual acuity was assessed by the investigator using the Snellen chart and converted to the logarithm of the minimum angle of resolution (logMAR). logMAR ideal is 0.0 and represents 20/20 Snellen visual acuity. logMAR values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal.
Overall Comfort
Time frame: 2 weeks
After two weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (senofilcon A and lotrafilcon B) using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
Overall Comfort
Time frame: 2 weeks and 4 weeks
After four weeks of wear, subjects responded to a phone survey question regarding overall comfort of the study contact lenses (lotrafilcon B)using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.

3 secondary outcomes

Limbal Redness
Time frame: 2 weeks
Bulbar Redness
Time frame: 2 weeks
Symptoms of Dryness
Time frame: 2 weeks

Results and safety

Results posted to the registry on 22 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Senofilcon A	184	177
Lotrafilcon B	195	183

Primary outcome: Average Corneal Staining

Time frame: 2 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	Senofilcon A n = 177	Lotrafilcon B n = 183
Value	0.157 (0.018)	0.170 (0.018)

Senofilcon A vs Lotrafilcon B: Mean Difference (Final Values): -0.014 (97.46% CI -0.058 to 0.031), Mixed Models Analysis

Population analysed: Analysis included all subjects that completed the study.

Primary outcome: Visual Acuity

Time frame: 2 weeks. Least squares mean (Standard Error). Unit: logMAR units

Measure	Senofilcon A n = 177	Lotrafilcon B n = 183
Value	-0.012 (0.003)	-0.002 (0.003)

Senofilcon A vs Lotrafilcon B: Mean Difference (Final Values): -0.010 (97.46% CI -0.021 to -0.010), Mixed Models Analysis

Primary outcome: Overall Comfort

Time frame: 2 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	Senofilcon A n = 177	Lotrafilcon B n = 183
Value	3.938 (0.090)	3.536 (0.091)

Senofilcon A vs Lotrafilcon B: Mean Difference (Final Values): 0.402 (97.46% CI 0.117 to 0.402), Mixed Models Analysis

Population analysed: Analysis includes subjects that completed the study.

Primary outcome: Overall Comfort

Time frame: 2 weeks and 4 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	Lotrafilcon B at 2 Weeks n = 183	Lotrafilcon B at 4 Weeks n = 183
Value	3.534 (0.111)	3.436 (0.118)

Lotrafilcon B at 2 Weeks vs Lotrafilcon B at 4 Weeks: Mean Difference (Final Values): 0.098 (97.46% CI -0.218 to 0.098), Mixed Models Analysis

Population analysed: Analysis includes all subjects that 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
Senofilcon A	0 of 184 (0%)	0 of 184 (0%)	Not reported
Lotrafilcon B	0 of 195 (0%)	0 of 195 (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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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.

Sheila, B Hickson-Curran, BSc, MCOptom study director

Johnson & Johnson Vision Care, Inc.

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

Questions about this trial

What is this clinical trial studying?

A study testing senofilcon A and lotrafilcon B in people with Myopia, run by Johnson & Johnson Vision Care, Inc. at 25 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 17 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 25 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 22 Mar 2011). 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?

Average Corneal Staining (time frame: 2 weeks). 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 NCT00975585.

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.