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CompletedNCT01695369Updated Jul 28, 2020Results posted

Evaluation of Comfilcon A and Senofilcon A Lenses

An interventional study of Senofilcon A; Comfilcon A and Comfilcon A; Senofilcon A in Myopia, sponsored by CooperVision International Limited (CVIL). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-28.

Sponsored by CooperVision International Limited (CVIL) · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Evaluation of Comfilcon A and Senofilcon A Lenses

Read the detailed description

Non-dispensing, single-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.

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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 61 is below the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

CooperVision International Limited (CVIL) is the lead sponsor of 138 studies on the registry; 9 are open to participants now.

Of its 72 completed or terminated interventional studies of FDA-regulated products, 67 (93%) have results posted.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Subjects must satisfy the following conditions prior to inclusion in the study:

  • Has had an oculo-visual examination in the last two years
  • Is at least 18 years of age and has full legal capacity to volunteer
  • Has read and understood the information consent letter
  • Is willing and able to follow instructions and maintain the appointment schedule
  • Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
  • Currently wears soft contact lenses at least 3 days a week, 8 hours a day
  • Has clear corneas and no active ocular disease
  • Has not worn lenses for at least 12 hours before the examination
  • 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 (e.g. entropion, ectropion, chalazia, recurrent styes)
    • No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).
    • No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)
    • No aphakia
    • Has prescription to match the available power range.

Exclusion criteria

Exclusion Criteria:

Any of the following will render a subject ineligible for inclusion:

  • Greater than 0.75 of refractive astigmatism in either eye
  • Has never worn contact lenses before
  • Wears contact lenses on an extended wear basis
  • Has any systemic disease affecting ocular health
  • Is a known sufferer of ocular allergies
  • Is taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
  • Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities
  • Is aphakic
  • Has undergone corneal refractive surgery.
  • Is wearing monovision
  • Is participating in any other type of clinical or research study
  • Female who is currently pregnant or is breast-feeding
  • Has > grade 1 ocular corneal staining in both type and extent by > grade 2 in either type or extent
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Study design

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

Study arms

  • Active comparator
    Senofilcon A

    Senofilcon A; Comfilcon A

    Device: Senofilcon A; Comfilcon A · Device: Comfilcon A; Senofilcon A

  • Experimental
    Comfilcon A

    Comfilcon A; Senofilcon A

    Device: Senofilcon A; Comfilcon A · Device: Comfilcon A; Senofilcon A

Interventions

  • DeviceSenofilcon A; Comfilcon A

    Senofilcon A; Comfilcon A

  • DeviceComfilcon A; Senofilcon A

    Comfilcon A; Senofilcon A

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What researchers measure

Primary outcomes

  1. Subjective Responses for Comfort Rated on a 0-100 Visual Scale.

    Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)

    Time frame: Baseline Insertion, 10 Minutes, 5 hours and 10 hours

07

Results

Posted Mar 6, 2014

Participant flow

Participant flow — Overall Study
MilestoneOverall Study Participants
Started61
Completed61
Not completed0

Outcome measures

PrimarySubjective Responses for Comfort Rated on a 0-100 Visual Scale.

Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)

Time frame:
Baseline Insertion, 10 Minutes, 5 hours and 10 hours
Reported as:
Mean · units on a scale
Subjective Responses for Comfort Rated on a 0-100 Visual Scale.
units on a scaleComfilcon ASenofilcon A
Baseline Insertion86 ± 1587 ± 13
10 Minutes89 ± 1491 ± 12
5 Hours83 ± 1984 ± 18
10 Hours79 ± 2381 ± 21

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Overall Study Participants—0/61 (0%)0/61 (0%)
Comfilcon A—0/61 (0%)0/61 (0%)

Baseline characteristics

Subjects

Age, Customized
Age, Customized(eyes)Overall Study Participants
<=18 years0
Between 18 and 65 years61
>=65 years0
Age, Continuous
Age, Continuous(years)Overall Study Participants
Mean26 ± 6
Sex: Female, Male
Sex: Female, Male(Participants)Overall Study Participants
Female38
Male23
Region of Enrollment
Region of Enrollment(participants)Overall Study Participants
United States61
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Study locations

1 site
  • University of Houston College of Optometry, TERTC
    Houston, Texas 77204, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01695369
Lead sponsor
CooperVision International Limited (CVIL)
Responsible party
Sponsor
First posted
Sep 28, 2012
Start date
Aug 2012
Primary completion
Aug 2012
Completion
Aug 2012
Results posted
Mar 6, 2014
Last update
Jul 28, 2020

Study contacts

Jan Bergmanson, OD, PhD
principal investigator · University of Houston College of Optometry, TERTC

Oversight

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

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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