CClinicalTrials.gg
CompletedNCT02345720Updated Jun 19, 2018Results posted

Effects of Multifocal Contact Lens on Ocular Tissue

An interventional study of etafilcon - PVP (multi-focal) in Visual Acuity, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-19.

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

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
40 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the etafilcon - PVP (multi-focal)

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. The subject must be between 40 and 70 years of age.
  4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of 1.00 too -5.75 in each eye.
  5. The subject must identify themselves as Asian by self-report and have eyes and eyelids with an automatically Asian appearance.
  6. The subject's refractive cylinder must be less than or equal to -0.75D in each eye.
  7. The subject's ADD power must be in the range of +0.75 D to +2.5 D in each eye.
  8. The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
  9. Subjects own a wearable pair of spectacles, if required for their distance vision.
  10. The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 5 days per week for at least 8 hours per day, for one month or more duration).
  11. The subject must already 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".

Exclusion criteria

Exclusion Criteria:

  1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued)
  2. Any ocular or systemic allergies that contraindicate contact lens wear.
  3. Any ocular or systemic disease, autoimmune disease, or use of medication, that will contraindicate contact lens wear.
  4. Any ocular abnormality that may interfere with contact lens wear.
  5. Use of any ocular medications, with the exception of rewetting drops.
  6. Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
  7. Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
  8. History of herpetic keratitis.
  9. Any ocular infection or inflammation.
  10. Any corneal distortion or irregular cornea.
  11. History of binocular vision abnormality or strabismus.
  12. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV).
  13. History of diabetes.
  14. Habitual wearer of etafilcon-A contact lens material.
  15. 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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    etafilcon - PVP (multi-focal)

    The investigational soft contact lenses will be worn in a daily wear modality for 30 days over the course of the study.

    Device: etafilcon - PVP (multi-focal)

Interventions

  • Deviceetafilcon - PVP (multi-focal)

    The investigational contact lens must be worn at least six hours daily.

06

What researchers measure

Primary outcomes

  1. Upper Eye Lid Margin Staining

    Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm\^2.

    Time frame: 30 days Post wear

  2. Limbal Staining

    Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported.

    Time frame: 30 Days Post Wear

  3. Corneal Staining

    The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported.

    Time frame: 30 Days Post Wear

07

Results

Posted Oct 5, 2016

Participant flow

Participant flow — Overall Study
MilestoneEtafilcon PVP (Multi-focal)
Started20
Completed20
Not completed0

Outcome measures

PrimaryUpper Eye Lid Margin Staining

Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm\^2.

Time frame:
30 days Post wear
Reported as:
Mean · mm^2
Upper Eye Lid Margin Staining
mm^2Etafilcon PVP (Multi-focal)
Upper Eye Lid Margin Staining1.96 ± 1.03
PrimaryLimbal Staining

Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported.

Time frame:
30 Days Post Wear
Reported as:
Mean · percentage of limbal area
Limbal Staining
percentage of limbal areaEtafilcon PVP (Multi-focal)
Nasal1.03 ± 1.30
Temporal0.68 ± 1.38
PrimaryCorneal Staining

The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported.

Time frame:
30 Days Post Wear
Reported as:
Mean · percentage of upper corneal quadrant
Corneal Staining
percentage of upper corneal quadrantEtafilcon PVP (Multi-focal)
Corneal Staining0.05 ± 0.12

Adverse events

Collected over Throughout the duration of the study. Approximately 3 months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Etafilcon PVP (Multi-focal)—0/20 (0%)0/20 (0%)

Baseline characteristics

All subjects that were dispensed a study lens.

Age, Continuous
Age, Continuous(Years)Etafilcon PVP (Multi-focal)
Mean50.6 ± 6.85
Sex: Female, Male
Sex: Female, Male(Participants)Etafilcon PVP (Multi-focal)
Female15
Male5
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Etafilcon PVP (Multi-focal)
Asian20
Region of Enrollment
Region of Enrollment(Participants)Etafilcon PVP (Multi-focal)
United Kingdom20
08

Study locations

1 site
  • London, SW1E6AU, United Kingdom
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
NCT02345720
Lead sponsor
Johnson & Johnson Vision Care, Inc.
Responsible party
Sponsor
First posted
Jan 26, 2015
Start date
Dec 2014
Primary completion
May 2015
Completion
May 2015
Results posted
Oct 5, 2016
Last update
Jun 19, 2018

Oversight

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

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