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CompletedNCT02920970Updated Jan 16, 2019Results posted

The Clinical Comparison of Narafilcon A and Stenfilcon A Contact Lenses

An interventional study of narafilcon A and stenfilcon A in Myopia, sponsored by CooperVision International Limited (CVIL). Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-16.

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

Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to compare the clinical performance and subjective acceptance of the narafilcon A lens with the stenfilcon A lens when used on a daily wear, daily disposable basis.

Read the detailed description

This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross comparison. Seventy subjects will use each lens type for a week in a random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.

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 72 is close to 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 and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subjects will only be eligible for the study if:

    1. They are of legal age (18) and capacity to volunteer.
    2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
    3. They are willing and able to follow the protocol.
    4. They agree not to participate in other clinical research for the duration of this study.
    5. They have a contact lens spherical prescription between -1.00 to - 6.00D (Diopters) (inclusive)
    6. They have a spectacle cylindrical correction of -0.75D or less in each eye.
    7. They can be satisfactorily fitted with the study lens types.
    8. At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
    9. They currently use soft contact lenses or have done so in the previous six months.
    10. They are willing to comply with the wear schedule (at least six days per week and for at least eight hours per day).
    11. They own a wearable pair of spectacles.

Exclusion criteria

Exclusion Criteria:

  • Subjects will not be eligible to take part in the study if:

    1. They have an ocular disorder which would normally contra-indicate contact lens wear.
    2. They have a systemic disorder which would normally contra-indicate contact lens wear.
    3. They are using any topical medication such as eye drops or ointment.
    4. They have had cataract surgery.
    5. They have had corneal refractive surgery.
    6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
    7. They are pregnant or breast-feeding.
    8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
    9. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
    10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
    11. They currently wear either the stenfilcon A lens or narafilcon A lens.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
72 participants (actual)

Study arms

  • Active comparator
    narafilcon A

    Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.

    Device: narafilcon A

  • Active comparator
    stenfilcon A

    Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.

    Device: stenfilcon A

Interventions

  • Devicenarafilcon A

    contact lens

  • Devicestenfilcon A

    contact lens

06

What researchers measure

Primary outcomes

  1. Ocular Physiology

    Ocular physiology assessment of narafilcon A and stenfilcon A lenses by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

    Time frame: 1 week

  2. Visual Acuity

    Visual acuity for narafilcon A and stenfilcon A are assessed by LogMAR. High contrast is measured with black letters on a white background. Low contrast is measured with gray letters on a white background.

    Time frame: 1 week

  3. Comfort Level of Stenfilcon A and Narafilcon A Lenses

    Subjective responses for overall comfort will be evaluated for each pair using questionnaire (Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

    Time frame: 1 week

  4. Dryness of Stenfilcon A and Narafilcon A Lenses

    Subjective responses for dryness will be evaluated for each pair using questionnaire (Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness).

    Time frame: 1 week

  5. Vision of Stenfilcon A and Narafilcon A Lenses

    Subjective responses for vision will be evaluated for each pair using questionnaire (Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent).

    Time frame: 1 week

  6. Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses

    Lens surface for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)

    Time frame: 1 week

  7. Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses

    Lens wettability for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)

    Time frame: 1 week

  8. Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses

    Horizontal centration assessed for narafilcon A and stenfilcon A lenses categorized as extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.

    Time frame: 1 week

  9. Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses

    Vertical centration assessed for narafilcon A and stenfilcon A lenses and graded as extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.

    Time frame: 1 week

  10. Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses

    Corneal coverage will be assessed for narafilcon A and stenfilcon A and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.

    Time frame: 1 week

  11. Lens Movement

    Lens movement assessed for narafilcon A and senofilcon A lenses and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.

    Time frame: 1 week

07

Results

Posted Jan 16, 2019

Participant flow

First Intervention
Participant flow — First Intervention
MilestoneStenfilcon A First Then Narafilcon ANarafilcon A First Then Stenfilcon A
Started3832
Completed3830
Not completed02
Withdrew: Protocol violation01
Withdrew: Adverse event01
Second Intervention
Participant flow — Second Intervention
MilestoneStenfilcon A First Then Narafilcon ANarafilcon A First Then Stenfilcon A
Started3830
Completed3730
Not completed10
Withdrew: Poor lens fit10

Outcome measures

PrimaryOcular Physiology

Ocular physiology assessment of narafilcon A and stenfilcon A lenses by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

Time frame:
1 week
Reported as:
Mean · units on a scale
Ocular Physiology
units on a scaleStenfilcon ANarafilcon A
Conjuctival hyperaemia0.84 ± 0.250.76 ± 0.27
Limbal hyperaemia0.75 ± 0.280.62 ± 0.31
Corneal vascularisation0.05 ± 0.140.03 ± 0.09
Microcysts0.00 ± 0.000.00 ± 0.00
Oedema0.00 ± 0.000.00 ± 0.00
Corneal staining0.31 ± 0.410.33 ± 0.40
Conjuctival staining0.57 ± 0.490.76 ± 0.64
Papillary conjuctivitis1.01 ± 0.351.00 ± 0.31
PrimaryVisual Acuity

Visual acuity for narafilcon A and stenfilcon A are assessed by LogMAR. High contrast is measured with black letters on a white background. Low contrast is measured with gray letters on a white background.

Time frame:
1 week
Reported as:
Mean · LogMAR
Visual Acuity
LogMARStenfilcon ANarafilcon A
High Contrast-0.12 ± 0.07-0.10 ± 0.08
Low Contrast0.17 ± 0.090.17 ± 0.10
PrimaryComfort Level of Stenfilcon A and Narafilcon A Lenses

Subjective responses for overall comfort will be evaluated for each pair using questionnaire (Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

Time frame:
1 week
Reported as:
Mean · units on a scale
Comfort Level of Stenfilcon A and Narafilcon A Lenses
units on a scaleStenfilcon ANarafilcon A
Comfort Level of Stenfilcon A and Narafilcon A Lenses91.4 ± 9.883.1 ± 14.8
PrimaryDryness of Stenfilcon A and Narafilcon A Lenses

Subjective responses for dryness will be evaluated for each pair using questionnaire (Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness).

Time frame:
1 week
Reported as:
Mean · units on a scale
Dryness of Stenfilcon A and Narafilcon A Lenses
units on a scaleStenfilcon ANarafilcon A
Dryness of Stenfilcon A and Narafilcon A Lenses82.1 ± 17.281.2 ± 16.7
PrimaryVision of Stenfilcon A and Narafilcon A Lenses

Subjective responses for vision will be evaluated for each pair using questionnaire (Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent).

Time frame:
1 week
Reported as:
Mean · units on a scale
Vision of Stenfilcon A and Narafilcon A Lenses
units on a scaleStenfilcon ANarafilcon A
Vision of Stenfilcon A and Narafilcon A Lenses91.4 ± 9.488.4 ± 14.6
PrimaryLens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses

Lens surface for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)

Time frame:
1 week
Reported as:
Count of participants · Participants
Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses
ParticipantsStenfilcon ANarafilcon A
Grade 06462
Grade 145
Grade 201
Grade 300
Grade 400
PrimaryLens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses

Lens wettability for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)

Time frame:
1 week
Reported as:
Count of participants · Participants
Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses
ParticipantsStenfilcon ANarafilcon A
Grade 05559
Grade 185
Grade 244
Grade 310
Grade 400
PrimaryLens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses

Horizontal centration assessed for narafilcon A and stenfilcon A lenses categorized as extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.

Time frame:
1 week
Reported as:
Count of participants · Participants
Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses
ParticipantsStenfilcon ANarafilcon A
Extremely Nasal00
Slightly Nasal00
Optimum4446
Slightly Temporal2422
Extremely Temporal00
PrimaryLens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses

Vertical centration assessed for narafilcon A and stenfilcon A lenses and graded as extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.

Time frame:
1 week
Reported as:
Count of participants · Participants
Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses
ParticipantsStenfilcon ANarafilcon A
Extremely inferior00
Slightly inferior1112
Optimum4248
Slightly superior158
Extremely superior00
PrimaryLens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses

Corneal coverage will be assessed for narafilcon A and stenfilcon A and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.

Time frame:
1 week
Reported as:
Count of participants · Participants
Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses
ParticipantsStenfilcon ANarafilcon A
Extremely inadequate00
Slightly inadequate42
Optimum5660
Slighlty excessive86
Extremely excessive00
PrimaryLens Movement

Lens movement assessed for narafilcon A and senofilcon A lenses and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.

Time frame:
1 week
Reported as:
Count of participants · Participants
Lens Movement
ParticipantsStenfilcon ANarafilcon A
Extremely inadequate00
Slightly inadequate35
Optimum5554
Slightly excessive109
Extremely excessive00

Adverse events

Collected over 1 week. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Stenfilcon A0/70 (0%)0/70 (0%)2/70 (2.9%)
Narafilcon A0/70 (0%)0/70 (0%)6/70 (8.6%)
Most frequent other events
Most frequent other events
EventStenfilcon ANarafilcon A
Non-ocular Non-SignificantRespiratory, thoracic and mediastinal disorders2/706/70

Baseline characteristics

Age, Continuous
Age, Continuous(years)Overall Number of Baseline Participants
Mean32.8 ± 11.4
Sex: Female, Male
Sex: Female, Male(Participants)Overall Number of Baseline Participants
Female45
Male27
08

Study locations

1 site
  • Eurolens Research - The University of Manchester
    Manchester, M13 9PL, United Kingdom
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02920970
Lead sponsor
CooperVision International Limited (CVIL)
Responsible party
Sponsor
First posted
Sep 30, 2016
Start date
Sep 1, 2016
Primary completion
Dec 22, 2016
Completion
May 31, 2017
Results posted
Jan 16, 2019
Last update
Jan 16, 2019

Study contacts

Philip Morgan, PhD, FAAO, FBCLA
study director · Eurolens Research, University of Manchester

Oversight

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

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