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CompletedNCT00584727Updated May 21, 2015Results posted

In-office Evaluation of Two Toric Soft Contact Lenses and a Spherical Soft Contact Lens

An interventional study of senofilcon A toric contact lens and alphafilcon A toric in Astigmatism, sponsored by Johnson & Johnson Vision Care, Inc.. Completed. Open to participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2015-05-21.

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

Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years to 39 Years
Sex
All
01

Study summary

The purpose of this study is to determine the relative performance of a new toric soft contact lens against a toric and a spherical contact lens currently available in market, specifically with regards to the fit and visual acuity as well as the comfort, vision and satisfaction while in the practitioner's office. Approximately 2 hours duration.

Read the detailed description

Non-dispensing, single-masked (subject-masked), randomised, controlled study.

02

Conditions studied

  • Astigmatism

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Keywords

  • astigmatism
  • visual acuity
  • fit
  • comfort
  • satisfaction
  • contact lens
03

In context

Astigmatism

413 studies on the registry are indexed under Astigmatism; 55 are open to participants now.

This study's enrollment of 96 is above the median of 55 across 321 interventional studies indexed under Astigmatism.

Browse Astigmatism 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 39 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. be at least 18 and less than or equal to 39 years of age and have a need for vision correction in BOTH eyes (monovision or uniocular fitting is NOT allowed).
  2. be of Asian descent (Japanese, Chinese, Korean, Polynesian or other Asian ancestry) and have Asian Eye anatomy
  3. have successfully worn toric or spherical soft (hydrogel or silicone hydrogel) contact lenses for at least 4-weeks prior to enrollment in the study.
  4. be able and willing to adhere to the instructions set forth in the protocol.
  5. agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
  6. have a distance spherical component between -1.00 D and -5.50 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 20 ° of the horizontal in both eyes
  7. have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye.
  8. be in good general health, based on his/her knowledge.
  9. read, be given an explanation of, indicate understanding of, and sign the STATEMENT OF INFORMED CONSENT.

Exclusion criteria

Exclusion Criteria:

  1. The subject is a rigid gas permeable (RGP) or daily disposable soft lens wearer.
  2. The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
  3. The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjögren's syndrome, type II diabetes, etc).

  4. Slit lamp findings that would contraindicate contact lens wear such as:

    • Pathological dry eye or associated findings
    • Pterygium or corneal scars within the visual axis
    • Neovascularization >1mm in from the limbus
    • History of giant papillary conjunctivitis (GPC) worse than Grade 2
    • Anterior uveitis or iritis (past or present)
    • Seborrhoeic eczema, seborrhoeic conjunctivitis
  5. A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
  6. A known history of corneal hypoesthesia (reduced corneal sensitivity.)
  7. Aphakia, keratoconus or a highly irregular cornea.
  8. Current pregnancy or lactation (to the best of the subject's knowledge).
  9. Active participation in another clinical study at any time during this study.
05

Study design

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

Study arms

  • Active comparator
    senofilcon A/alphafilcon A/etafilcon A

    First intervention:senofilcon A toric contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: etafilcon A sphere contact lenses

    Device: senofilcon A toric contact lens · Device: alphafilcon A toric · Device: etafilcon A sphere

  • Active comparator
    alphafilcon A/etafilcon A/senofilcon A

    First intervention: alphafilcon A toric contact lenses Second intervention: etafilcon A sphere contact lenses Third intervention: senofilcon A toric contact lenses

    Device: senofilcon A toric contact lens · Device: alphafilcon A toric · Device: etafilcon A sphere

  • Active comparator
    etafilcon A/senofilcon A/alphafilcon A

    First intervention: etafilcon A sphere contact lenses Second intervention:senofilcon A toric contact lenses Third intervention: alphafilcon A toric contact lenses

    Device: senofilcon A toric contact lens · Device: alphafilcon A toric · Device: etafilcon A sphere

  • Active comparator
    senofilcon A/etafilcon A/alphafilcon A

    First intervention: senofilcon A toric contact lenses Second intervention: etafilcon A sphere contact lenses Third intervention: alphafilcon A toric contact lenses

    Device: senofilcon A toric contact lens · Device: alphafilcon A toric · Device: etafilcon A sphere

  • Active comparator
    alphafilcon A/senofilcon A/etafilcon A

    First intervention: alphafilcon A toric contact lenses Second intervention: senofilcon A toric contact lenses Third intervention: etafilcon A sphere contact lenses

    Device: senofilcon A toric contact lens · Device: alphafilcon A toric · Device: etafilcon A sphere

  • Active comparator
    etafilcon A/alphafilcon A/senofilcon A

    First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses

    Device: senofilcon A toric contact lens · Device: alphafilcon A toric · Device: etafilcon A sphere

Interventions

  • Devicesenofilcon A toric contact lens

    contact lens

  • Devicealphafilcon A toric

    contact lens

  • Deviceetafilcon A sphere

    contact lens

06

What researchers measure

Primary outcomes

  1. Visual Acuity

    Number of eyes with Distance Visual Acuity 20/20 or better

    Time frame: 15-20 minutes

  2. Patient Reported Vision

    A weighted combined score calculated from individual confort-vision related questions asked on a 1-5 scale, 1=most negative resonse to 5=most positive response, was used to derive vision scores. The analysis shows the difference in outcome between test and control. \>0=greater vision, \<0=lesser vision.

    Time frame: 15-20 minutes

  3. Lens Orientation Within 5 Degrees

    Meaures in what position does the lens sit on the eye at insertion and is measured in degrees of rotation.

    Time frame: 1 minute

  4. Lens Stability Within 5 Degrees

    Measures if the lens changes position on the eye as it is worn and is measured in degrees of rotation.

    Time frame: 1 minute

  5. Patient Reported Comfort.

    A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. \>0=comfortable, \<0=uncomfortable

    Time frame: 15-20 minutes

  6. Patient Preference

    This outcome measures which lens the subjects preferred to wear.

    Time frame: end of study

07

Results

Posted Feb 10, 2010

Participant flow

First Intervention
Participant flow — First Intervention
MilestoneSenofilcon A/Alphafilcon A/Etafilcon AAlphafilcon A/Etafilcon A/Senofilcon AEtafilcon A/Senofilcon A/Alphafilcon ASenofilcon A/Etafilcon A/Alphafilcon AAlphafilcon A/Senofilcon A/Etafilcon AEtafilcon A/Alphafilcon A/Senofilcon A
Started171716141616
Completed171715141616
Not completed001000
Withdrew: Discontinuation001000
Second Intervention
Participant flow — Second Intervention
MilestoneSenofilcon A/Alphafilcon A/Etafilcon AAlphafilcon A/Etafilcon A/Senofilcon AEtafilcon A/Senofilcon A/Alphafilcon ASenofilcon A/Etafilcon A/Alphafilcon AAlphafilcon A/Senofilcon A/Etafilcon AEtafilcon A/Alphafilcon A/Senofilcon A
Started171715141616
Completed171715141616
Not completed000000
Third Intervention
Participant flow — Third Intervention
MilestoneSenofilcon A/Alphafilcon A/Etafilcon AAlphafilcon A/Etafilcon A/Senofilcon AEtafilcon A/Senofilcon A/Alphafilcon ASenofilcon A/Etafilcon A/Alphafilcon AAlphafilcon A/Senofilcon A/Etafilcon AEtafilcon A/Alphafilcon A/Senofilcon A
Started171715141616
Completed171714141214
Not completed001042
Withdrew: Protocol violation001042

Outcome measures

PrimaryVisual Acuity

Number of eyes with Distance Visual Acuity 20/20 or better

Time frame:
15-20 minutes
Reported as:
Number · Eyes with Snellen VA 20/20 or better
Visual Acuity
Eyes with Snellen VA 20/20 or betterSenofilcon A ToricAlphafilcon A ToricEtafilcon A Sphere
Visual Acuity14613637
Statistical analysis
  • Senofilcon A Toric vs Etafilcon A Sphere · Chi-squared · p = <0.0001
PrimaryPatient Reported Vision

A weighted combined score calculated from individual confort-vision related questions asked on a 1-5 scale, 1=most negative resonse to 5=most positive response, was used to derive vision scores. The analysis shows the difference in outcome between test and control. \>0=greater vision, \<0=lesser vision.

Time frame:
15-20 minutes
Reported as:
Least squares mean · Scores on a scale
Patient Reported Vision
Scores on a scaleSenofilcon A ToricAlphafilcon A ToricEtafilcon A Sphere
Patient Reported Vision0.2845 ± 0.0980.1332 ± 0.098-0.4310 ± 0.097
Statistical analysis
  • Senofilcon A Toric vs Etafilcon A Sphere · Mixed Models Analysis · Mean difference (final values): 0.7155 · 95% CI 0.3625 to 0.7155Mean difference was senofilcon A toric minus etafilcon A sphere.
PrimaryLens Orientation Within 5 Degrees

Meaures in what position does the lens sit on the eye at insertion and is measured in degrees of rotation.

Time frame:
1 minute
Reported as:
Number · degrees
Lens Orientation Within 5 Degrees
degreesSenofilcon A ToricAlphafilcon A Toric
Lens Orientation Within 5 Degrees142126
Statistical analysis
  • Senofilcon A Toric vs Alphafilcon A Toric · Chi-squared · p = 0.2161
PrimaryLens Stability Within 5 Degrees

Measures if the lens changes position on the eye as it is worn and is measured in degrees of rotation.

Time frame:
1 minute
Reported as:
Number · degrees
Lens Stability Within 5 Degrees
degreesSenofilcon A ToricAlphafilcon A Toric
Lens Stability Within 5 Degrees156140
Statistical analysis
  • Senofilcon A Toric vs Alphafilcon A Toric · Chi-squared · p = 0.1328
PrimaryPatient Reported Comfort.

A weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale, 1=most negative response to 5=most positive response, was used to derive comfort outcomes. The analysis shows the difference in outcome between the test and control. \>0=comfortable, \<0=uncomfortable

Time frame:
15-20 minutes
Reported as:
Least squares mean · Scores on a scale
Patient Reported Comfort.
Scores on a scaleSenofilcon A ToricAlphafilcon A ToricEtafilcon A Sphere
Patient Reported Comfort.0.1425 ± 0.1034-0.3464 ± 0.10350.2176 ± 0.1028
Statistical analysis
  • Senofilcon A Toric vs Alphafilcon A Toric · Mixed Models Analysis · Mean difference (final values): 0.4890 · 95% CI 0.1529 to 0.4890Mean difference was senofilcon A toric minus alphafilcon A toric
PrimaryPatient Preference

This outcome measures which lens the subjects preferred to wear.

Time frame:
end of study
Reported as:
Number · Number of participants
Patient Preference
Number of participantsSenofilcon A ToricAlphafilcon A ToricEtafilcon A Sphere
Patient Preference62518
Statistical analysis
  • Senofilcon A Toric vs Etafilcon A Sphere · Chi-squared · p = <0.0001

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Senofilcon A/Alphafilcon A/Etafilcon A—0/17 (0%)0/17 (0%)
Alphafilcon A/Etafilcon A/Senofilcon A—0/17 (0%)0/17 (0%)
Etafilcon A/Senofilcon A/Alphafilcon A—0/16 (0%)0/16 (0%)
Senofilcon A/Etafilcon A/Alphafilcon A—0/14 (0%)0/14 (0%)
Alphafilcon A/Senofilcon A/Etafilcon A—0/16 (0%)0/16 (0%)
Etafilcon A/Alphafilcon A/Senofilcon A—0/16 (0%)0/16 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Completed Population
Mean28.0 ± 5.96
Sex: Female, Male
Sex: Female, Male(Participants)Completed Population
Female52
Male36
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00584727
Lead sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
Foresight Regulatory Strategies, Inc.
First posted
Jan 2, 2008
Start date
Sep 2007
Primary completion
Nov 2007
Completion
Nov 2007
Results posted
Feb 10, 2010
Last update
May 21, 2015

Study contacts

Jason Chin, O.D.
principal investigator
James Fujimoto, O.D.
principal investigator
Weslie Hamada, OlD.
principal investigator · Arthur T. Kobayashi, O.D., Inc.
Dennis Kuwuabara, O.D.
principal investigator · Eye Care Associates of Hawaii
Mark Nakano, O.D.
principal investigator · Mark E. Nakano Optometric Corp.
Ikuko Sugimoto, O.D.
principal investigator
Kevin Rosin, O.D.
principal investigator · Drs. Farkas, Kassalow, Resnick & Associates
Jennifer Kao, O.D.
principal investigator

Oversight

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

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