CClinicalTrials.gg
CompletedNCT03059810Updated Dec 24, 2019Results posted

Clinical Evaluation of Investigational Multifocal Contact Lenses

An interventional study of etafilcon A in Visual Acuity, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 9 sites in United States. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-24.

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

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Not applicable
Ages
40 Years to 70 Years
Sex
All
01

Study summary

3-visit dispensing study to evaluate the subjective feedback of a multifocal contact lens in a population of presbyopic patients. Subjects will wear the contact lenses for a total of 12-16 days.

02

Conditions studied

  • Visual Acuity
03

In context

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
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Healthy adult males or females that are at least 40 years of age and no more than 70 years of age.
  4. The subject must either be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not, respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".(Appendix B).
  5. The subject is a current soft spherical or toric contact lens wearer (defined as a minimum of 6 hours of wear per day at least two days of the week for a minimum of 1 month prior to the study).
  6. The subject's refractive spherical component must be between +1.25 Diopters (D) to +3.75 D in each eye.
  7. The subject's refractive cylinder must be -1.00 D to -1.50 D in each eye.
  8. The subject's refractive cylinder axis must be 90°±30° or 180°±30° in each eye.
  9. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
  10. The subject must have best corrected distance visual acuity of 20/20-3 or better in each eye.
  11. The subject must have a wearable pair of spectacles if required for their distance vision.

Exclusion criteria

Exclusion Criteria:

  1. Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.
  2. Pregnancy or lactation.
  3. Currently diagnosed with diabetes.
  4. Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).
  5. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
  6. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
  7. Any previous, or planned, ocular or intraocular surgery (e.g.radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), lid procedures, cataract surgery, retinal surgery, etc.).
  8. A history of amblyopia, strabismus or binocular vision abnormality.
  9. Any ocular infection or inflammation.
  10. Any ocular abnormality that may interfere with contact lens wear.
  11. Use of any ocular medication, with the exception of rewetting drops.
  12. History of herpetic keratitis.
  13. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Participating Subjects

    Participating Subjects who are habitual soft contact lens wearers, aged 40 to 70 years of age, will be dispensed investigational contact lenses to be worn from 12-16 days, to include a total of 3 visits.

    Device: etafilcon A

Interventions

  • Deviceetafilcon A

    Investigational Contact Lens

06

What researchers measure

Primary outcomes

  1. Overall Vision

    Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) 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: 12-16 Day Follow-up

07

Results

Posted Dec 24, 2019

Participant flow

A total of 72 subjects were enrolled into this study. Of the enrolled subjects 63 were dispensed at least one study lens and 9 did not meet the eligibility criteria. All 63 dispensed subjects completed the study.

Participant flow — Overall Study
MilestoneEtafilcon A With PVP
Started63
Completed63
Not completed0

Outcome measures

PrimaryOverall Vision

Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) 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:
12-16 Day Follow-up
Reported as:
Mean · Units on a Scale
Overall Vision
Units on a ScaleEtafilcon A With PVP
Overall Vision47.33 ± 18.646
Statistical analysis
  • Etafilcon A With PVP · Linear mixed model (LMM) · Mean difference (final values): 0.7 · 95% CI -4.6 to 5.9Mean difference was calculated as Test (at 12-16 days follow up) - Habitual (at baseline)

Adverse events

Collected over Throughout the entire duration of the study. Approximately 2-weeks per subject.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Etafilcon A With PVP0/63 (0%)0/63 (0%)0/63 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Etafilcon A With PVP
Mean56.5 ± 6.65
Sex: Female, Male
Sex: Female, Male(Participants)Etafilcon A With PVP
Female48
Male15
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Etafilcon A With PVP
Black or African American2
White61
Region of Enrollment
Region of Enrollment(Participants)Etafilcon A With PVP
United States63
08

Study locations

9 sites
  • EYE Center Optometric
    Rocklin, California 95677, United States
  • Dr. Ted Brink & Associates
    Jacksonville, Florida 32225, United States
  • Vistakon Research Clinic
    Jacksonville, Florida 32256, United States
  • Golden Vision
    Sarasota, Florida 34232, United States
  • Eye Associates of Winter Park
    Winter Park, Florida 32792, United States
  • University of Indiana School of Optometry
    Bloomington, Indiana 47405, United States
  • Sacco Eye Group
    Vestal, New York 13850, United States
  • Optometry Group, PLLC
    Memphis, Tennessee 38111, United States
  • Total Eye Care, PA
    Memphis, Tennessee 38119, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 1, 2017

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03059810
Lead sponsor
Johnson & Johnson Vision Care, Inc.
Responsible party
Sponsor
First posted
Feb 23, 2017
Start date
Jan 27, 2017
Primary completion
Apr 25, 2017
Completion
Apr 25, 2017
Results posted
Dec 24, 2019
Last update
Dec 24, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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