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CompletedNCT00975585Updated Jun 19, 2018Results posted

Clinical Performance Comparison of Two Contact Lenses

An interventional study of senofilcon A and lotrafilcon B in Myopia, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 25 sites in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2018-06-19.

Sponsored by Johnson & Johnson Vision Care, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
379
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Myopia

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03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 379 is above the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Johnson & Johnson Vision Care, Inc. is the lead sponsor of 220 studies on the registry; 2 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 101 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
379 participants (actual)

Study arms

  • Active comparator
    senofilcon A both eyes

    soft contact lens worn daily for 2 weeks, with a 2-week replacement regimen.

    Device: senofilcon A

  • Active comparator
    lotrafilcon B both eyes

    soft contact lens worn daily for 4 weeks, with a 4-week replacement regimen

    Device: lotrafilcon B

Interventions

  • Devicesenofilcon A

    soft contact lens, 2-week replacement indicated

  • Devicelotrafilcon B

    soft contact lens with a 4-week replacement indicated.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 weeks

  2. 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.

    Time frame: 2 weeks

  3. 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.

    Time frame: 2 weeks

  4. 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.

    Time frame: 2 weeks and 4 weeks

Secondary outcomes

  1. Limbal Redness

    The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe

    Time frame: 2 weeks

  2. Bulbar Redness

    The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe

    Time frame: 2 weeks

  3. 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

    Time frame: 2 weeks

07

Results

Posted Mar 22, 2011

Participant flow

Participant flow — Overall Study
MilestoneSenofilcon ALotrafilcon B
Started184195
Completed177183
Not completed712
Withdrew: Adverse event04
Withdrew: Lost to follow-up35
Withdrew: Withdrawal by subject21
Withdrew: Lens issue22

Outcome measures

PrimaryAverage 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.

Time frame:
2 weeks
Reported as:
Least squares mean · units on a scale
Average Corneal Staining
units on a scaleSenofilcon ALotrafilcon B
Average Corneal Staining0.157 ± 0.0180.170 ± 0.018
Statistical analysis
  • Senofilcon A vs Lotrafilcon B · Mixed Models Analysis · Mean difference (final values): -0.014 · 97.46% CI -0.058 to 0.031The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis is adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.
PrimaryVisual 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.

Time frame:
2 weeks
Reported as:
Least squares mean · logMAR units
Visual Acuity
logMAR unitsSenofilcon ALotrafilcon B
Visual Acuity-0.012 ± 0.003-0.002 ± 0.003
Statistical analysis
  • Senofilcon A vs Lotrafilcon B · Mixed Models Analysis · Mean difference (final values): -0.010 · 97.46% CI -0.021 to -0.010The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.
PrimaryOverall 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.

Time frame:
2 weeks
Reported as:
Least squares mean · units on a scale
Overall Comfort
units on a scaleSenofilcon ALotrafilcon B
Overall Comfort3.938 ± 0.0903.536 ± 0.091
Statistical analysis
  • Senofilcon A vs Lotrafilcon B · Mixed Models Analysis · Mean difference (final values): 0.402 · 97.46% CI 0.117 to 0.402The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject as random effects.
PrimaryOverall 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.

Time frame:
2 weeks and 4 weeks
Reported as:
Least squares mean · units on a scale
Overall Comfort
units on a scaleLotrafilcon B at 2 WeeksLotrafilcon B at 4 Weeks
Overall Comfort3.534 ± 0.1113.436 ± 0.118
Statistical analysis
  • Lotrafilcon B at 2 Weeks vs Lotrafilcon B at 4 Weeks · Mixed Models Analysis · Mean difference (final values): 0.098 · 97.46% CI -0.218 to 0.098The mean difference is lotrafilcon B at 2 weeks minus lotrafilcon B at 4 weeks. Analysis adjusted for duration of wear, stie, duration of wear by site interaction as fixed effects, subject as random effects.
SecondaryLimbal Redness

The investigator assessed limbal redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe

Time frame:
2 weeks
Reported as:
Least squares mean · units on a scale
Limbal Redness
units on a scaleSenofilcon ALotrafilcon B
Limbal Redness0.376 ± 0.0310.499 ± 0.030
Statistical analysis
  • Senofilcon A vs Lotrafilcon B · Mixed Models Analysis · Mean difference (final values): -0.123 · 98.2% CI -0.123 to -0.051The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.
SecondaryBulbar Redness

The investigator assessed bulbar redness using the following scale: 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe

Time frame:
2 weeks
Reported as:
Least squares mean · units on a scale
Bulbar Redness
units on a scaleSenofilcon ALotrafilcon B
Bulbar Redness0.465 ± 0.0310.532 ± 0.030
Statistical analysis
  • Senofilcon A vs Lotrafilcon B · Mixed Models Analysis · Mean difference (final values): -0.068 · 98.2% CI -0.068 to 0.008The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by site interaction as fixed effects, subject and eye nested within subject as random effects.
SecondarySymptoms 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

Time frame:
2 weeks
Reported as:
Least squares mean · units on a scale
Symptoms of Dryness
units on a scaleSenofilcon ALotrafilcon B
Symptoms of Dryness2.003 ± 0.0872.414 ± 0.088
Statistical analysis
  • Senofilcon A vs Lotrafilcon B · Mixed Models Analysis · Mean difference (final values): -0.411 · 98.2% CI -0.411 to -0.117The mean difference is calculated as senofilcon A minus lotrafilcon B. Analysis adjusted for lens type, site, lens type by stie interaction as fixed effects, subject as random effects.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Senofilcon A—0/184 (0%)0/184 (0%)
Lotrafilcon B—0/195 (0%)0/195 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Senofilcon ALotrafilcon BTotal
Mean29.7 ± 7.029.3 ± 6.929.5 ± 6.9
Sex: Female, Male
Sex: Female, Male(Participants)Senofilcon ALotrafilcon BTotal
Female125136261
Male5959118
Region of Enrollment
Region of Enrollment(participants)Senofilcon ALotrafilcon BTotal
United States184195379
08

Study locations

25 sites
  • North Little Rock, Arkansas 72116, United States
  • Campbell, California 95008, United States
  • Colorado Springs, Colorado 80909, United States
  • Jacksonville, Florida 32205, United States
  • Jacksonville, Florida 32256, United States
  • Miami, Florida 33155, United States
  • Winter Park, Florida 32792, United States
  • Roswell, Georgia 30076, United States
  • Boston, Massachusetts 02114, United States
  • Cambridge, Massachusetts 02140, United States
  • Blue Springs, Missouri 64015, United States
  • New York, New York 10001, United States
  • Chagrin Falls, Ohio 44023, United States
  • North Olmsted, Ohio 44070, United States
  • Warren, Ohio 44484, United States
  • State College, Pennsylvania 16801, United States
  • Warwick, Rhode Island 02888, United States
  • Chamberlain, South Dakota 57325, United States
  • Hot Springs, South Dakota 57747, United States
  • Bartlett, Tennessee 38134, United States
  • Brentwood, Tennessee 37027, United States
  • Memphis, Tennessee 38119, United States
  • Tyler, Texas 757703, United States
  • Burlington, Vermont 05401, United States
  • West Allis, Wisconsin 53227, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00975585
Lead sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
Visioncare Research Ltd.
Responsible party
Sponsor
First posted
Sep 11, 2009
Start date
Aug 1, 2009
Primary completion
Oct 1, 2009
Completion
Oct 1, 2009
Results posted
Mar 22, 2011
Last update
Jun 19, 2018

Study contacts

Sheila, B Hickson-Curran, BSc, MCOptom
study director · Johnson & Johnson Vision Care, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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