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CompletedNCT02406495Updated Jul 29, 2020Results posted

Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week

An interventional study of filcon IV 1 and ocufilcon D in Myopia and Hyperopia, sponsored by CooperVision International Limited (CVIL). Completed at 1 site in Spain. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-07-29.

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

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

Study summary

Open label, 1-week daily disposable, dispensing study

Read the detailed description

Evaluate the clinical performance of habitual wearers of FILCON IV 1 sphere lenses when refitted with ocufilcon D asphere for 1 week of daily disposable wear.

02

Conditions studied

  • Myopia
  • Hyperopia

Browse trials for

03

In context

Hyperopia

140 studies on the registry are indexed under Hyperopia; 18 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 112 interventional studies indexed under Hyperopia.

Browse Hyperopia 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
No

Inclusion criteria

  • Is between 18 and 40 years of age (inclusive)
  • Has had a self-reported visual exam in the last two years
  • Is an adapted Avaira sphere contact lens wearer (at least 1 week in Avaira sphere)
  • Has a contact lens spherical prescription between + 2.25 to - 8.00 (inclusive)
  • Has a spectacle cylinder up to 0.75D 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:

  • Is not a habitual wearer of Avaira sphere lenses
  • Has a CL 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 2-4) 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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    filcon IV 1 and ocufilcon D

    Habitual wearers of filcon IV 1 sphere lenses refitted with asphere ocufilcon D lenses.

    Device: filcon IV 1 · Device: ocufilcon D

Interventions

  • Devicefilcon IV 1

    contact lens

  • Deviceocufilcon D

    contact lens

06

What researchers measure

Primary outcomes

  1. Lens Fit, Centration - Filcon IV 1 and Ocufilcon D

    Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable

    Time frame: Baseline and 1 Week

  2. Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D

    Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

    Time frame: Baseline and 1 Week

  3. Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D

    Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement

    Time frame: Baseline and 1 Week

  4. Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D

    Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.

    Time frame: Baseline and 1 Week

Secondary outcomes

  1. Visual Acuity - Filcon IV 1 and Ocufilcon D

    Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity).

    Time frame: Baseline and 1 Week

  2. Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D

    Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel).

    Time frame: Baseline and 1 Week

  3. Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D

    Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness).

    Time frame: Baseline and 1 Week

  4. Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D

    Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle).

    Time frame: Baseline and 1 Week

  5. Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D

    Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied).

    Time frame: Baseline and 1 Week

  6. Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D

    Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D.

    Time frame: 1 Week

  7. Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D

    Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

    Time frame: Baseline and 1 Week

  8. Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D

    Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

    Time frame: Baseline and 1 Week

  9. Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D

    Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

    Time frame: Baseline and 1 Week

  10. Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D

    Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

    Time frame: Baseline and 1 Week

  11. Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D

    Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

    Time frame: Baseline and 1 Week

07

Results

Posted May 3, 2016

Participant flow

Participant flow — Overall Study
MilestoneOverall Participants
Started40
Completed40
Not completed0

Outcome measures

SecondaryVisual Acuity - Filcon IV 1 and Ocufilcon D

Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity).

Time frame:
Baseline and 1 Week
Reported as:
Mean · LogMAR
Visual Acuity - Filcon IV 1 and Ocufilcon D
LogMARFilcon IV 1Ocufilcon D
OD0 ± 00 ± 0
OS0 ± 00 ± 0
Binocular-0.01 ± 0.03-0.01 ± 0.04
SecondaryComfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D

Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel).

Time frame:
Baseline and 1 Week
Reported as:
Mean · units on a scale
Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
units on a scaleFilcon IV 1Ocufilcon D
Comfort on insertion7.4 ± 1.18.1 ± 1.3
Comfort prior to removal7.3 ± 1.48.1 ± 1.3
Comfort overall7.3 ± 1.38.1 ± 1.4
PrimaryLens Fit, Centration - Filcon IV 1 and Ocufilcon D

Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable

Time frame:
Baseline and 1 Week
Reported as:
Number · percentage of eyes
Lens Fit, Centration - Filcon IV 1 and Ocufilcon D
percentage of eyesFilcon IV 1 OD (Oculus Dexter)Filcon IV 1 OS (Oculus Sinister)Ocufilcon D OD (Oculus Dexter)Ocufilcon D OS (Oculus Sinister)
Optimum58709898
Decentration acceptable433033
Decentration unacceptable0000
PrimaryLens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D

Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

Time frame:
Baseline and 1 Week
Reported as:
Number · percentage of eyes
Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D
percentage of eyesFilcon IV 1 ODFilcon IV 1 OSOcufilcon D ODOcufilcon D OS
0=Insufficient, unacceptable movement0000
1=Minimal, but acceptable movement101000
2=Optimal movement23181010
3=Moderate, but acceptable movement65709090
4=Excessive, unacceptable movement3300
PrimaryLens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D

Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement

Time frame:
Baseline and 1 Week
Reported as:
Mean · percentage of mean lens tightness
Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D
percentage of mean lens tightnessFilcon IV 1Ocufilcon D
OD49.1 ± 5.950.1 ± 0.79
OS48.9 ± 5.250.0 ± 1.9
PrimaryLens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D

Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.

Time frame:
Baseline and 1 Week
Reported as:
Number · percentage of eyes
Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D
percentage of eyesFilcon IV 1 ODFilcon IV 1 OSOcufilcon D ODOcufilcon D OS
Should not be worn0000
Borderline but acceptable0000
Min. acceptable0000
Not perfect but OK383500
Perfect6365100100
SecondaryDryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D

Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness).

Time frame:
Baseline and 1 Week
Reported as:
Mean · units on a scale
Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
units on a scaleFilcon IV 1Ocufilcon D
Dryness during day7.2 ± 1.38.0 ± 1.5
Dryness prior to removal7.3 ± 1.38.0 ± 1.5
Overall dryness7.3 ± 1.38.1 ± 1.5
SecondaryHandling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D

Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle).

Time frame:
Baseline and 1 Week
Reported as:
Mean · units on a scale
Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
units on a scaleFilcon IV 1Ocufilcon D
Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D7.4 ± 1.28.2 ± 1.3
SecondaryVision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D

Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied).

Time frame:
Baseline and 1 Week
Reported as:
Mean · units on a scale
Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
units on a scaleFilcon IV 1Ocufilcon D
Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D7.5 ± 1.38.2 ± 1.3
SecondaryLens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D

Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D.

Time frame:
1 Week
Reported as:
Number · percentage of participants
Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D
percentage of participantsFilcon IV 1Ocufilcon D
Comfort2080
Dryness2080
Handling2080
Vision2080
Overall2080
SecondaryLens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D

Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

Time frame:
Baseline and 1 Week
Reported as:
Number · percentage of participants
Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D
percentage of participantsFilcon IV 1Ocufilcon D
Completely Satisfied2060
Somewhat Satisfied6835
Somewhat Dissatisfied135
Completely Dissatisfied00
SecondaryLens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D

Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

Time frame:
Baseline and 1 Week
Reported as:
Number · percentage of participants
Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D
percentage of participantsFilcon IV 1Ocufilcon D
Completely Satisfied2060
Somewhat Satisfied6535
Somewhat Dissatisfied155
Completely Dissatisfied00
SecondaryLens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D

Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

Time frame:
Baseline and 1 Week
Reported as:
Number · percentage of participants
Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D
percentage of participantsFilcon IV 1Ocufilcon D
Completely Satisfied2360
Somewhat Satisfied6538
Somewhat Dissatisfied133
Completely Dissatisfied00
SecondaryLens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D

Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

Time frame:
Baseline and 1 Week
Reported as:
Number · percentage of participants
Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D
percentage of participantsFilcon IV 1Ocufilcon D
Completely Satisfied2360
Somewhat Satisfied6538
Somewhat Dissatisfied133
Completely Dissatisfied00
SecondaryLens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D

Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.

Time frame:
Baseline and 1 Week
Reported as:
Number · percentage of participants
Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D
percentage of participantsFilcon IV 1Ocufilcon D
Completely Satisfied2060
Somewhat Satisfied6835
Somewhat Dissatisfied135
Completely Dissatisfied00

Adverse events

Collected over From dispense up to one week for each study lenses. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Overall Participants—0/40 (0%)0/40 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Overall Participants
Mean23.92 ± 5.43
Sex: Female, Male
Sex: Female, Male(Participants)Overall Participants
Female31
Male9
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 Jul 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02406495
Lead sponsor
CooperVision International Limited (CVIL)
Responsible party
Sponsor
First posted
Apr 2, 2015
Start date
Apr 2015
Primary completion
Apr 2015
Completion
May 2015
Results posted
May 3, 2016
Last update
Jul 29, 2020

Study contacts

Robert Montés-Mico, OD MPhil PhD
principal investigator · Optometry Research Group (GIO) Optics Department, University of Valencia

Oversight

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

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