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CompletedNCT02670473Updated Feb 5, 2018Results posted

Clinical Performance of Existing Wearers of Enfilcon A Following a Refit With Fanfilcon A Lenses for 4 Weeks

An interventional study of fanfilcon A (test) in Myopia, sponsored by CooperVision International Limited (CVIL). Completed at 1 site in Spain. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-05.

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

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
18 Years to 40 Years
Sex
All
01

Study summary

The aim of this dispensing study is to evaluate the clinical performance of habitual wearers of enfilcon A lenses following a refit with fanfilcon A lenses over 4 weeks of daily wear.

Read the detailed description

This is a 30 subject, prospective, dispensing, bilateral wear, subject-masked study, reviewing the refit characteristics in a group of enfilcon A wearers switched to the fanfilcon A lens. Subject's habitual enfilcon A lenses will be evaluated at the first vist and then re-fitted with a pair of fanfilcon A lenses for 4 weeks of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks, and 4 weeks.

02

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 35 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.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

A person is eligible for inclusion in the study if he/she:

  • Is between 18 and 40 years of age
  • Has had a self-reported visual exam in the last two years
  • Is an adapted enfilcon A contact lens wearer (at least 2 weeks in enfilcon A lens)
  • Has a contact lens spherical prescription between -1.00 to - 6.00
  • Has a spectacle cylinder up to 0.75D (Diopters) in each eye.
  • Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
  • Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
  • Has clear corneas and no active ocular disease
  • Has read, understood, and signed the information consent letter.
  • Patient contact lens refraction should fit within the available parameters of the study lenses.
  • Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
  • Is willing to comply with the visit schedule

Exclusion criteria

Exclusion Criteria

A person will be excluded from the study if he/she:

  • Is not a habitual wearer of enfilcon A lenses
  • Has a CL (Contact Lens) prescription outside the range of the available parameters of the study lenses.
  • Has a spectacle cylinder ≥1.00D of cylinder in either eye.
  • Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
  • Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
  • Presence of clinically significant (grade 3-4) anterior segment abnormalities
  • Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.

  • Slit lamp findings that would contraindicate contact lens wear such as:

    • Pathological dry eye or associated findings
    • Pterygium, pinguecula, or corneal scars within the visual axis
    • Neovascularization > 0.75 mm in from of the limbus
    • Giant papillary conjunctivitis (GCP) worse than grade 1
    • Anterior uveitis or iritis (past or present)
    • Seborrheic eczema, Seborrheic conjunctivitis
    • History of corneal ulcers or fungal infections
    • Poor personal hygiene
  • Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
  • Has aphakia, keratoconus or a highly irregular cornea.
  • Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of eye related clinical or research study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
35 participants (actual)

Study arms

  • No intervention
    enfilcon A (habitual)

    Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.

  • Experimental
    fanfilcon A (test)

    Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.

    Device: fanfilcon A (test)

Interventions

  • Devicefanfilcon A (test)

    contact lens

06

What researchers measure

Primary outcomes

  1. Lens Fit - Centration

    Lens fit evaluation of centration for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: optimum, decentration acceptable, decentration unacceptable.

    Time frame: Baseline, 1 week, 2 weeks, and 4 weeks

  2. Lens Fit - Post-blink Movement

    Lens fit evaluation of post-blink movement for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-5 Likert scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement.

    Time frame: Baseline, 1 week, 2 weeks, and 4 weeks

  3. Lens Tightness on Push-up

    Lens fit evaluation of tightness on push-up test for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: 0%-100%, 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement.

    Time frame: Baseline, 1 week, 2 weeks, and 4 weeks

  4. Overall Fit Acceptance

    Overall fit acceptance for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect.

    Time frame: Baseline, 1 week, 2 weeks, and 4 weeks

Secondary outcomes

  1. Overall Comfort

    Subjective rating of overall comfort for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=could feel, 10=cannot feel.

    Time frame: Baseline, 1 week, 2 weeks, and 4 weeks

  2. Dryness Overall

    Subjective rating of overall dryness for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dry, 10=no dryness.

    Time frame: Baseline, 1 week, 2 weeks, and 4 weeks

  3. Handling

    Subjective rating of handling for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.

    Time frame: Baseline, 1 week, 2 weeks, and 4 weeks

  4. Overall Vision Satisfaction

    Subjective rating of overall vision satisfaction for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dissatisfied, 10=very satisfied.

    Time frame: Baseline, 1 week, 2 weeks, and 4 weeks

  5. Overall Satisfaction

    Subjective rating of overall satisfaction for enfilcon A habitual lens (control) at baseline and fanfilcon A lens (test) at 1 week, 2 weeks, and 4 weeks. Scale 1-4, 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied.

    Time frame: Baseline, 1 week, 2 weeks, and 4 weeks

  6. Lens Preference Overall

    Subject's overall preference for one of two contact lenses. Forced choice: enfilcon A habitual lens (control) or fanfilcon A lens (test).

    Time frame: 1 week, 2 weeks, and 4 weeks

  7. Wearing Times

    Average wearing time and comfortable wearing times for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks measured by hours.

    Time frame: Baseline, 1 week, 2 weeks, and 4 weeks

  8. Conjunctival Staining

    Conjunctival staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. (Scale 0-4, 0.5 steps 0=normal, 4=severe).

    Time frame: Baseline, 1 week, 2 weeks, and 4 weeks

  9. Corneal Staining

    Corneal staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0.5 steps 0=normal, 4=severe.

    Time frame: Baseline, 1 week, 2 weeks, and 4 weeks

07

Results

Posted Mar 21, 2017

Participant flow

Participant flow — Overall Study
MilestoneOverall Participants
Started35
Completed34
Not completed1
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryLens Fit - Centration

Lens fit evaluation of centration for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: optimum, decentration acceptable, decentration unacceptable.

Time frame:
Baseline, 1 week, 2 weeks, and 4 weeks
Reported as:
Number · percentage of eyes
Lens Fit - Centration
percentage of eyesHabitual Lenses: BaselineFanfilcon A: 1 WeekFanfilcon A: 2 WeeksFanfilcon A: 4 Weeks
Optimum889799100
Decentration acceptable12310
Decentration unacceptable0000
PrimaryLens Fit - Post-blink Movement

Lens fit evaluation of post-blink movement for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-5 Likert scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement.

Time frame:
Baseline, 1 week, 2 weeks, and 4 weeks
Reported as:
Number · percentage of eyes
Lens Fit - Post-blink Movement
percentage of eyesHabitual Lenses: BaselineFanfilcon A: 1 WeekFanfilcon A: 2 WeeksFanfilcon A: 4 Weeks
Insufficient, unacceptable movement0000
Minimal, but acceptable movement1100
Optimal movement353618
Moderate, but acceptable movement64969179
Excessive, unacceptable movement0033
PrimaryLens Tightness on Push-up

Lens fit evaluation of tightness on push-up test for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale: 0%-100%, 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement.

Time frame:
Baseline, 1 week, 2 weeks, and 4 weeks
Reported as:
Mean · percentage of lens tightness
Lens Tightness on Push-up
percentage of lens tightnessHabitual Lenses: BaselineFanfilcon A: 1 WeekFanfilcon A: 2 WeeksFanfilcon A: 4 Weeks
Lens Tightness on Push-up50 ± 549 ± 250 ± 350 ± 3
PrimaryOverall Fit Acceptance

Overall fit acceptance for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect.

Time frame:
Baseline, 1 week, 2 weeks, and 4 weeks
Reported as:
Number · percentage of eyes
Overall Fit Acceptance
percentage of eyesHabitual Lenses: BaselineFanfilcon A: 1 WeekFanfilcon A: 2 WeeksFanfilcon A: 4 Weeks
Should not be worn0000
Borderline but unacceptable0000
Minimum acceptable0000
Not perfect but okay9073
Perfect911009397
SecondaryOverall Comfort

Subjective rating of overall comfort for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=could feel, 10=cannot feel.

Time frame:
Baseline, 1 week, 2 weeks, and 4 weeks
Reported as:
Mean · units on a scale
Overall Comfort
units on a scaleHabitual Lenses: BaselineFanfilcon A: 1 WeekFanfilcon A: 2 WeeksFanfilcon A: 4 Weeks
Overall Comfort8.03 ± 0.978.91 ± 1.068.97 ± 0.838.85 ± 0.96
SecondaryDryness Overall

Subjective rating of overall dryness for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dry, 10=no dryness.

Time frame:
Baseline, 1 week, 2 weeks, and 4 weeks
Reported as:
Mean · units on a scale
Dryness Overall
units on a scaleHabitual Lenses: BaselineFanfilcon A: 1 WeekFanfilcon A: 2 WeeksFanfilcon A: 4 Weeks
Dryness Overall7.88 ± 1.328.82 ± 1.098.85 ± 1.088.82 ± 0.94
SecondaryHandling

Subjective rating of handling for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.

Time frame:
Baseline, 1 week, 2 weeks, and 4 weeks
Reported as:
Mean · units on a scale
Handling
units on a scaleHabitual Lenses: BaselineFanfilcon A: 1 WeekFanfilcon A: 2 WeeksFanfilcon A: 4 Weeks
Handling8.85 ± 1.379.26 ± 1.169.59 ± 0.789.62 ± 0.74
SecondaryOverall Vision Satisfaction

Subjective rating of overall vision satisfaction for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-10, 0=very dissatisfied, 10=very satisfied.

Time frame:
Baseline, 1 week, 2 weeks, and 4 weeks
Reported as:
Mean · units on a scale
Overall Vision Satisfaction
units on a scaleHabitual Lenses: BaselineFanfilcon A: 1 WeekFanfilcon A: 2 WeeksFanfilcon A: 4 Weeks
Overall Vision Satisfaction9.24 ± 0.829.56 ± 0.799.79 ± 0.419.74 ± 0.51
SecondaryOverall Satisfaction

Subjective rating of overall satisfaction for enfilcon A habitual lens (control) at baseline and fanfilcon A lens (test) at 1 week, 2 weeks, and 4 weeks. Scale 1-4, 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied.

Time frame:
Baseline, 1 week, 2 weeks, and 4 weeks
Reported as:
Number · percentage of subjects
Overall Satisfaction
percentage of subjectsCompletely SatisfiedSomewhat SatisfiedSomewhat DissatisfiedCompletely Dissatisfied
Baseline - enfilcon A habitual lens (control)267130
1 week - fanfilcon A lens (test)534700
2 weeks - fanfilcon A lens (test)653500
4 weeks - fanfilcon A lens (test)712900
SecondaryLens Preference Overall

Subject's overall preference for one of two contact lenses. Forced choice: enfilcon A habitual lens (control) or fanfilcon A lens (test).

Time frame:
1 week, 2 weeks, and 4 weeks
Reported as:
Number · percentage of subjects
Lens Preference Overall
percentage of subjectsHabitual LensesFanfilcon A Lens (Test)
1 week1882
2 weeks694
4 weeks694
SecondaryWearing Times

Average wearing time and comfortable wearing times for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks measured by hours.

Time frame:
Baseline, 1 week, 2 weeks, and 4 weeks
Reported as:
Mean · hours
Wearing Times
hoursHabitual Lenses: BaselineFanfilcon A: 1 WeekFanfilcon A: 2 WeeksFanfilcon A: 4 Weeks
Average wearing time8.79 ± 1.679.82 ± 2.119.65 ± 1.699.85 ± 1.56
Comfortable wearing time7.65 ± 1.508.97 ± 2.448.91 ± 1.738.97 ± 1.40
SecondaryConjunctival Staining

Conjunctival staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. (Scale 0-4, 0.5 steps 0=normal, 4=severe).

Time frame:
Baseline, 1 week, 2 weeks, and 4 weeks
Reported as:
Number · percentage of eyes
Conjunctival Staining
percentage of eyesHabitual Lenses: BaselineFanfilcon A: 1 WeekFanfilcon A: 2 WeeksFanfilcon A: 4 Weeks
0100979994
0.50316
1.00000
1.50000
2.00000
2.50000
3.00000
3.50000
4.00000
SecondaryCorneal Staining

Corneal staining for enfilcon A habitual lens (control) is assessed at baseline and fanfilcon A lens (test) is assessed at 1 week, 2 weeks, and 4 weeks. Scale 0-4, 0.5 steps 0=normal, 4=severe.

Time frame:
Baseline, 1 week, 2 weeks, and 4 weeks
Reported as:
Number · percentage of eyes
Corneal Staining
percentage of eyesHabitual Lenses: BaselineFanfilcon A: 1 WeekFanfilcon A: 2 WeeksFanfilcon A: 4 Weeks
0100100100100
0.50000
1.00000
1.50000
2.00000
2.50000
3.00000
3.50000
4.00000

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Overall Participants—0/35 (0%)0/35 (0%)

Baseline characteristics

34 subjects completed the study and included in the baseline analysis.

Age, Continuous
Age, Continuous(years)Overall Participants
Mean24.15 ± 5.53
Sex: Female, Male
Sex: Female, Male(Participants)Overall Participants
Female24
Male10
08

Study locations

1 site
  • Optometry Research Group (GIO) Optics Department, University of Valencia
    Valencia, 46100, Spain
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02670473
Lead sponsor
CooperVision International Limited (CVIL)
Responsible party
Sponsor
First posted
Feb 1, 2016
Start date
Jan 2016
Primary completion
Mar 2016
Completion
May 2016
Results posted
Mar 21, 2017
Last update
Feb 5, 2018

Study contacts

Robert Montés-Mico, O.D., PhD
principal investigator · Optometry Research Group (GIO) University of Valencia

Oversight

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

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