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CompletedNCT01484054Updated Jun 19, 2018Results posted

Dispensing Evaluation of Subjective Comfort, Vision, and Handling of a New Lens Compared to a Marketed Lens

An interventional study of etafilcon A with print and PVP for dark eyes (EAPVPDE) and etafilcon A control lens (EADE) in Refractive Ametropia, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 6 sites in United States. Open to female participants aged 18 Years to 34 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
103
Allocation
Randomized
Ages
18 Years to 34 Years
Sex
Female
01

Study summary

To evaluate and compare the performance of a new contact lens to a marketed contact lens.

02

Conditions studied

  • Refractive Ametropia

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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 103 is above 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 34 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • The subject must be a healthy adult at least 18 years of age and no more than 34 years of age.
  • The subjects must be female, dark eye Caucasian, Non-Hispanic habitual soft contact lens wearer (both eyes).
  • The subject rated the Concept Statement positively (i.e., a rating of 4 or 5). If not the subject is not eligible to participate.
  • The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
  • The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.
  • The subject's optimal vertexed spherical equivalent distance correction must be between-1.00 and -4.00D.
  • Any cylinder power must be:\<=0.75D.
  • The subject must have visual acuity best correctable to 20/25 or better for each eye.
  • The subject must have normal eyes (no ocular medications or ocular infection of any type).
  • The subject must read and sign the Statement of Informed Consent.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion criteria

Exclusion Criteria:

  • Ocular or systemic allergies or disease which might interfere with contact lens wear.
  • Systemic disease, autoimmune disease, or use of medication which might interfere with contact lens wear.
  • Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
  • Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
  • Any ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Any color deficiencies (color blindness) - to the best of the subject's knowledge.
  • Pregnancy or lactation.
  • Diabetes.
  • Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
  • Habitual contact lens type is toric, multifocal, or is worn as extended wear.
  • Subject presents with one dark iris color and one light iris color
  • Subject has heterochromia iridis (a difference in color between parts of one iris)
  • The subject is an employee or family member of the clinical study site.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
103 participants (actual)

Study arms

  • Other
    EAPVPDE/EADE

    etafilcon A with embedded print and PVP lens for dark eyes worn daily during the first period of 7-9 days, then etafilcon A control lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods.

    Device: etafilcon A with print and PVP for dark eyes (EAPVPDE) · Device: etafilcon A control lens (EADE)

  • Other
    EADE/EAPVPDE

    etafilcon A control lens worn daily during the first period of 7-9 days, then etafilcon A with embedded print and PVP for dark eyes lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods.

    Device: etafilcon A with print and PVP for dark eyes (EAPVPDE) · Device: etafilcon A control lens (EADE)

Interventions

  • Deviceetafilcon A with print and PVP for dark eyes (EAPVPDE)

    A daily disposable contact lens

  • Deviceetafilcon A control lens (EADE)

    A marketed daily disposable contact lens

06

What researchers measure

Primary outcomes

  1. Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire

    The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range from 0-120.

    Time frame: After 7 to 9 days of lens wear

  2. Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire

    The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

    Time frame: After 7 to 9 days of lens wear

  3. Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire

    The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

    Time frame: After 7 to 9 days of lens wear

07

Results

Posted Jan 20, 2014

Participant flow

Period 1
Participant flow — Period 1
MilestoneEAPVPDE/EADEEADE/EAPVPDE
Started5050
Completed5049
Not completed01
Withdrew: Withdrawal by subject01
Period 2
Participant flow — Period 2
MilestoneEAPVPDE/EADEEADE/EAPVPDE
Started5049
Completed5049
Not completed00

Outcome measures

PrimarySubject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire

The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range from 0-120.

Time frame:
After 7 to 9 days of lens wear
Reported as:
Least squares mean · units on a scale
Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire
units on a scaleEAPVPDEEADE
Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire54.06 ± 2.53853.06 ± 2.537
Statistical analysis
  • EAPVPDE vs EADE · Mixed Models Analysis · Least square mean difference: 1.00 · 95% CI -3.20 to 5.20
PrimarySubject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire

The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

Time frame:
After 7 to 9 days of lens wear
Reported as:
Least squares mean · units on a scale
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire
units on a scaleEAPVPDEEADE
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire53.61 ± 2.20148.91 ± 2.197
Statistical analysis
  • EAPVPDE vs EADE · Mixed Models Analysis · Least square mean difference: 4.70 · 95% CI -0.79 to 10.19
PrimarySubject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire

The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

Time frame:
After 7 to 9 days of lens wear
Reported as:
Least squares mean · units on a scale
Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire
units on a scaleEAPVPDEEADE
Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire61.21 ± 1.84751.77 ± 1.842
Statistical analysis
  • EAPVPDE vs EADE · Mixed Models Analysis · Least square mean difference: 9.44 · 95% CI 5.81 to 13.07

Adverse events

Collected over Adverse events were recorded when the subjects were exposed to the Investigational lenses.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
EAPVPDE—0/100 (0%)0/100 (0%)
EADE—0/100 (0%)0/100 (0%)

Baseline characteristics

Baseline summary was conducted on all enrolled subjects who received study lenses.

Age, Continuous
Age, Continuous(years)All Subjects
Mean25.07 ± 4.879
Sex: Female, Male
Sex: Female, Male(Participants)All Subjects
Female100
Male0
Region of Enrollment
Region of Enrollment(participants)All Subjects
United States100
08

Study locations

6 sites
  • Bloomfield, Connecticut 06002, United States
  • Tallahassee, Florida 32308, United States
  • Overland Park, Kansas 66207, United States
  • Jamestown, New York 14750, United States
  • Kingston, Pennsylvania 18704, United States
  • Moon, Pennsylvania 15108, 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
NCT01484054
Lead sponsor
Johnson & Johnson Vision Care, Inc.
Responsible party
Sponsor
First posted
Dec 2, 2011
Start date
Nov 2011
Primary completion
Feb 2012
Completion
Feb 2012
Results posted
Jan 20, 2014
Last update
Jun 19, 2018

Oversight

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

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