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CompletedNCT00721500Updated May 21, 2015Results posted

A Comparison of Two Daily Disposable Contact Lenses.

An interventional study of etafilcon A and narafilcon A in Refractive Error and Myopia, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 60 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
25
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

This study seeks to evaluate the clinical fitting performance of a new daily disposable contact lens to an existing daily disposable contact lens.

02

Conditions studied

  • Refractive Error
  • Myopia

Browse trials for

03

In context

Refractive Errors

413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's enrollment of 25 is below the median of 82 across 296 interventional studies indexed under Refractive Errors.

Browse Refractive Errors 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 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • They are of legal age (18 years) and capacity to volunteer.
  • They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
  • They are willing and able to follow the protocol.
  • They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.
  • They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.
  • They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).
  • They have successfully worn contact lenses within six months of starting the study.

Exclusion criteria

Exclusion Criteria:

  • They have an ocular disorder which would normally contra-indicate contact lens wear.
  • They have a systemic disorder which would normally contra-indicate contact lens wear.
  • They are using any topical medication such as eye drops or ointment.
  • They are aphakic.
  • They have had corneal refractive surgery.
  • They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
  • They are pregnant or lactating.
  • They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
  • They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).
  • They have diabetes.
  • They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    narafilcon A / etafilcon A - etafilcon A - narafilcon A

    First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes.

    Device: etafilcon A · Device: narafilcon A

  • Experimental
    narafilcon A / etafilcon A - narafilcon A - etafilcon A

    First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes.

    Device: etafilcon A · Device: narafilcon A

  • Experimental
    narafilcon A - etafilcon A - narafilcon A / etafilcon A

    First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.

    Device: etafilcon A · Device: narafilcon A

  • Experimental
    etafilcon A - narafilcon A - narafilcon A / etafilcon A

    First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.

    Device: etafilcon A · Device: narafilcon A

Interventions

  • Deviceetafilcon A

    contact lens

    Also known as: 1-Day Acuvue Moist

  • Devicenarafilcon A

    contact lens

    Also known as: TruEye

06

What researchers measure

Primary outcomes

  1. Proportion of Eyes Successfully Fit

    Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses \>2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit'.

    Time frame: Within 20 minutes of lens insertion

  2. Lens Fit Decentration

    Lens centration was assessed in primary gaze, diffuse white light, low-medium magnification, with graticule. Lens fit decentration with respect to visible cornea was measured to nearest 0.1mm.

    Time frame: Within 20 minutes of lens insertion

  3. Lens Tightness on Cornea With Manual Digit Push Up

    Lens tightness on push-up assessed by digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. Tightness is measured on a 0%-100% continuous scale where 0%=falls from cornea without lid support, 50%=optimum and 100%=no movement.

    Time frame: Within 20 minutes of lens insertion

07

Results

Posted Mar 2, 2011

Participant flow

There were 25 subjects enrolled to the study.

Period One
Participant flow — Period One
MilestoneNarafilcon A/Etafilcon A - Etafilcon A - Narafilcon ANarafilcon A/Etafilcon A - Narafilcon A - Etafilcon ANarafilcon A - Etafilcon A - Narafilcon A/Etafilcon AEtafilcon A - Narafilcon A - Narafilcon A/Etafilcon A
Started6766
Completed6766
Not completed0000
Period Two
Participant flow — Period Two
MilestoneNarafilcon A/Etafilcon A - Etafilcon A - Narafilcon ANarafilcon A/Etafilcon A - Narafilcon A - Etafilcon ANarafilcon A - Etafilcon A - Narafilcon A/Etafilcon AEtafilcon A - Narafilcon A - Narafilcon A/Etafilcon A
Started6766
Completed6766
Not completed0000
Period Three
Participant flow — Period Three
MilestoneNarafilcon A/Etafilcon A - Etafilcon A - Narafilcon ANarafilcon A/Etafilcon A - Narafilcon A - Etafilcon ANarafilcon A - Etafilcon A - Narafilcon A/Etafilcon AEtafilcon A - Narafilcon A - Narafilcon A/Etafilcon A
Started6766
Completed6766
Not completed0000

Outcome measures

PrimaryProportion of Eyes Successfully Fit

Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses \>2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit'.

Time frame:
Within 20 minutes of lens insertion
Reported as:
Number · proportion of participant eyes
Proportion of Eyes Successfully Fit
proportion of participant eyesNarafilcon A (Bilateral)Narafilcon A (Contralateral)Etafilcon A (Bilateral)Etafilcon A (Contralateral)
Proportion of Eyes Successfully Fit0.980.960.960.96
PrimaryLens Fit Decentration

Lens centration was assessed in primary gaze, diffuse white light, low-medium magnification, with graticule. Lens fit decentration with respect to visible cornea was measured to nearest 0.1mm.

Time frame:
Within 20 minutes of lens insertion
Reported as:
Mean · mm
Lens Fit Decentration
mmNarafilcon ANarafilcon A (Contralateral)Etafilcon A (Bilateral)Etafilcon A (Contralateral)
Lens Fit Decentration0.25 ± 0.140.22 ± 0.160.27 ± 0.170.27 ± 0.15
PrimaryLens Tightness on Cornea With Manual Digit Push Up

Lens tightness on push-up assessed by digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. Tightness is measured on a 0%-100% continuous scale where 0%=falls from cornea without lid support, 50%=optimum and 100%=no movement.

Time frame:
Within 20 minutes of lens insertion
Reported as:
Mean · percentage
Lens Tightness on Cornea With Manual Digit Push Up
percentageNarafilcon A (Bilateral)Narafilcon A (Contralateral)Etafilcon A (Bilateral)Etafilcon A (Contralateral)
Lens Tightness on Cornea With Manual Digit Push Up44.6 ± 6.346.9 ± 5.556.3 ± 8.658.1 ± 7.8

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Narafilcon A/Etafilcon A - Etafilcon A - Narafilcon A—0/6 (0%)0/6 (0%)
Narafilcon A/Etafilcon A - Narafilcon A - Etafilcon A—0/7 (0%)0/7 (0%)
Narafilcon A - Etafilcon A - Narafilcon A/Etafilcon A—0/4 (0%)0/4 (0%)
Etafilcon A - Narafilcon A - Narafilcon A/Etafilcon A—0/2 (0%)0/2 (0%)

Baseline characteristics

All enrolled and completed subjects were included in the baseline summary.

Age, Continuous
Age, Continuous(years)All Subjects
Mean44.9 ± 11.9
Sex: Female, Male
Sex: Female, Male(Participants)All Subjects
Female17
Male8
Region of Enrollment
Region of Enrollment(participants)All Subjects
United Kingdom25
08

Study locations

1 site
  • Visioncare Research Ltd
    Farnham, Surrey GU9 7EN, United Kingdom
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
NCT00721500
Lead sponsor
Johnson & Johnson Vision Care, Inc.
Collaborators
Visioncare Research Ltd.
Responsible party
Sponsor
First posted
Jul 24, 2008
Start date
Jun 2008
Primary completion
Jul 2008
Completion
Jul 2008
Results posted
Mar 2, 2011
Last update
May 21, 2015
View the source record on ClinicalTrials.gov ↗

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