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CompletedNCT02920983Updated Oct 17, 2019Results posted

A Clinical Comparison of Three Soft Daily Disposable Contact Lenses

An interventional study of somofilcon A and nelfilcon A II 2 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 2019-10-17.

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

Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study aims to compare the clinical performance of the somfilcon A, nelfilcon A II 2 and omafilcon A II 2 daily disposable contact lenses.

Read the detailed description

This will be a randomised, subject-masked, crossover, bilateral study, controlled by cross comparison. Fifty subjects will use each lens type for a week in 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 51 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 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. 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.
    8. They currently use soft contact lenses or have done so in the previous six months.
    9. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).

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.
05

Study design

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

Study arms

  • Active comparator
    somofilcon A

    Subjects are randomized to wear somofilcon A for one week during the cross over study.

    Device: somofilcon A

  • Active comparator
    nelfilcon A II 2

    Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study.

    Device: nelfilcon A II 2

  • Active comparator
    omafilcon A ll 2

    Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study.

    Device: omafilcon A ll 2

Interventions

  • Devicesomofilcon A

    contact lens

  • Devicenelfilcon A II 2

    contact lens

  • Deviceomafilcon A ll 2

    contact lens

06

What researchers measure

Primary outcomes

  1. Ocular Physiology

    Ocular physiology assessment of by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

    Time frame: 1 week

Secondary outcomes

  1. Lens Fit - Horizontal Centration

    Horizontal centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.

    Time frame: 1 week

  2. Lens Fit - Vertical Centration

    Vertical centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.

    Time frame: 1 week

  3. Lens Fit - Corneal Coverage

    Corneal coverage will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.

    Time frame: 1 week

  4. Lens Fit - Movement

    Lens movement assessed using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.

    Time frame: 1 week

  5. Lens Surface - Deposition

    Lens surface will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe

    Time frame: 1 week

  6. Lens Surface - Wettability

    Lens wettability will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe

    Time frame: 1 week

  7. Visual Acuity

    Visual acuity will be assessed by LogMAR.

    Time frame: 1 week

07

Results

Posted Jun 26, 2019

Participant flow

55 subjects were recruited for the study, 51 subjects were enrolled and 50 subjects completed the initial follow up visit.

Dispense 1
Participant flow — Dispense 1
MilestoneSomofilcon A, Nelfilcon A II 2, Omafilcon A II 2Somofilcon A, Omafilcon A II 2, Nelfilcon A II 2Nelfilcon A II 2, Somofilcon A, Omafilcon A II 2Nelfilcon A II 2, Omafilcon A II 2, Somofilcon AOmafilcon A II 2, Nelficon A II 2, Somofilcon AOmafilcon A II 2, Somofilcon A, Nelfilcon A II 2
Started81076137
Completed81076127
Not completed000010
Withdrew: Unacceptable lens fit000010
Dispense 2
Participant flow — Dispense 2
MilestoneSomofilcon A, Nelfilcon A II 2, Omafilcon A II 2Somofilcon A, Omafilcon A II 2, Nelfilcon A II 2Nelfilcon A II 2, Somofilcon A, Omafilcon A II 2Nelfilcon A II 2, Omafilcon A II 2, Somofilcon AOmafilcon A II 2, Nelficon A II 2, Somofilcon AOmafilcon A II 2, Somofilcon A, Nelfilcon A II 2
Started81076137
Completed71076127
Not completed100010
Withdrew: Unscceptable lens fit100010
Dispense 3
Participant flow — Dispense 3
MilestoneSomofilcon A, Nelfilcon A II 2, Omafilcon A II 2Somofilcon A, Omafilcon A II 2, Nelfilcon A II 2Nelfilcon A II 2, Somofilcon A, Omafilcon A II 2Nelfilcon A II 2, Omafilcon A II 2, Somofilcon AOmafilcon A II 2, Nelficon A II 2, Somofilcon AOmafilcon A II 2, Somofilcon A, Nelfilcon A II 2
Started81076137
Completed7976127
Not completed110010
Withdrew: Unacceptable lens fit110010

Outcome measures

PrimaryOcular Physiology

Ocular physiology assessment of 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 scaleSomofilcon ANelfilcon A II 2Omafilcon A ll 2
Conjunctival Hyperemia0.76 ± 0.260.79 ± 0.310.78 ± 0.28
Limbal Hyperaemia0.63 ± 0.240.66 ± 0.300.65 ± 0.28
Corneal Vascularization0.05 ± 0.110.05 ± 0.100.06 ± 0.09
Microcysts0.00 ± 0.000.00 ± 0.000.00 ± 0.00
Oedema0.00 ± 0.000.00 ± 0.000.00 ± 0.00
Corneal Staining0.33 ± 0.420.42 ± 0.430.26 ± 0.36
Conjunctival Staining1.37 ± 0.650.41 ± 0.430.23 ± 0.20
Paipliiary Conjunctivitis0.95 ± 0.280.88 ± 0.350.93 ± 0.34
SecondaryLens Fit - Horizontal Centration

Horizontal centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.

Time frame:
1 week
Reported as:
Count of participants · Participants
Lens Fit - Horizontal Centration
ParticipantsSomofilcon ANelfilcon A II 2Omafilcon A ll 2
Extremely Nasal000
Slightly Nasal131
Optimum282826
Slightly Temporal201722
Extremely Temporal000
SecondaryLens Fit - Vertical Centration

Vertical centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.

Time frame:
1 week
Reported as:
Count of participants · Participants
Lens Fit - Vertical Centration
ParticipantsSomofilcon ANelfilcon A II 2Omafilcon A ll 2
Extremely Nasal000
Slightly Nasal112022
Optimum212222
Slightly Temporal1765
Extremely Temporal000
SecondaryLens Fit - Corneal Coverage

Corneal coverage will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.

Time frame:
1 week
Reported as:
Count of participants · Participants
Lens Fit - Corneal Coverage
ParticipantsSomofilcon ANelfilcon A II 2Omafilcon A ll 2
Extremely Nasal000
Slightly Nasal374
Optimum463941
Slightly Temporal024
Extremely Temporal000
SecondaryLens Fit - Movement

Lens movement assessed using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.

Time frame:
1 week
Reported as:
Count of participants · Participants
Lens Fit - Movement
ParticipantsSomofilcon ANelfilcon A II 2Omafilcon A ll 2
Extremely inadequate000
Slightly inadequate31912
Optimum382727
Slightly excessive829
Extremely excessive001
SecondaryLens Surface - Deposition

Lens surface will be assessed using 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
ParticipantsSomofilcon ANelfilcon A II 2Omafilcon A ll 2
Grade 0464748
Grade 1311
Grade 2000
Grade 3000
Grade 4000
SecondaryLens Surface - Wettability

Lens wettability will be assessed using 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
ParticipantsSomofilcon ANelfilcon A II 2Omafilcon A ll 2
Grade 0374443
Grade 1933
Grade 2313
Grade 3000
Grade 4000
SecondaryVisual Acuity

Visual acuity will be assessed by LogMAR.

Time frame:
1 week
Reported as:
Mean · LogMAR
Visual Acuity
LogMARSomofilcon ANelfilcon A II 2Omafilcon A ll 2
High Contrast-0.11 ± 0.08-0.13 ± 0.08-0.11 ± 0.07
Low Contrast0.18 ± 0.100.17 ± 0.110.18 ± 0.10

Adverse events

Collected over Subjects were randomized to wear each pair of lenses (Somofilcon A, Nelfilcon A II 2, Omafilcon A II 2 at a random sequence) for One- Week in a random sequence, assessed overall for up to 4 weeks.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Somofilcon A0/49 (0%)0/49 (0%)4/49 (8.2%)
Nelfilcon A II 20/48 (0%)0/48 (0%)3/48 (6.3%)
Omafilcon A II 20/49 (0%)0/49 (0%)4/49 (8.2%)
Most frequent other events
Most frequent other events
EventSomofilcon ANelfilcon A II 2Omafilcon A II 2
Common coldInfections and infestations4/493/484/49

Baseline characteristics

55 subjects were recruited for the study with 50 subjects completing initial follow up visit. 5 subjects were ineligible to be dispensed with lenses for sphere out of range or cylinder out of range.

Age, Continuous
Age, Continuous(years)Overall Study
Mean35.6 ± 12.9
Sex: Female, Male
Sex: Female, Male(Participants)Overall Study
Female35
Male20
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 Oct 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02920983
Lead sponsor
CooperVision International Limited (CVIL)
Responsible party
Sponsor
First posted
Sep 30, 2016
Start date
Sep 2016
Primary completion
Nov 2016
Completion
Feb 2017
Results posted
Jun 26, 2019
Last update
Oct 17, 2019

Study contacts

Carole Maldonado-Codinal, PhD, FAAO
principal investigator · Eurolens Research, University of Manchester

Oversight

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

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