AmetropiaNCT04067141

The Clinical Comparison of Somofilcon A 1 Day and Nelfilcon A Daily Disposable Contact Lenses

A study testing somofilcon A and nelfilcon A in people with Ametropia, run by CooperVision, Inc. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This subject-masked, randomized, bilateral crossover study will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily disposable lens when used on a daily wear, daily disposable basis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ametropia
What is being tested?: somofilcon A and nelfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteUnited Kingdom
Study dates: 4 Jul 2019to 20 Nov 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

They are of legal age (18) and capacity to volunteer.
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They agree not to participate in other clinical research for the duration of this study.
They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)
They have a maximum of -1.00DC ocular astigmatism in each eye.

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They can be satisfactorily fitted with the study lens types.
At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
They currently use soft contact lenses or have done so in the previous six months.
They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
They own a wearable pair of spectacles.

Who cannot join

They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They have had cataract surgery.
They have had corneal refractive surgery.
They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

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They are pregnant or breast-feeding.
They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
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.
They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
They currently wear either the clariti 1day or the DAILIES AquaComfort Plus lens.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Eurolens Research
Manchester, M13 9PL

Other trials in United Kingdom

About this study

Official title: The Clinical Comparison of the Clariti 1 Day and DAILIES AquaComfort PLUS Daily Disposable Contact Lenses

Read the detailed description

This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross-comparison. This will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily disposable lens when used on a daily wear, daily disposable basis.

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.

Conditions: Ametropia
Being tested: somofilcon A, nelfilcon A
Medical subject headings: Refractive Errors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

somofilcon ADevice
Also called somofilcon A 1 day, test lens, clariti 1 day
Contact Lens
nelfilcon ADevice
Also called nelfilcon A Daily Disposable Contact Lens, control lens, DAILIES AquaComfort PLUS daily disposable
Contact Lens

Study groups in NCT04067141
Study group	Role	What they receive
somofilcon A, then nelfilcon A	Experimental	Subjects will bilaterally wear the somofilcon A lenses, then crossover to nelfilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week. Receives: Device: somofilcon A; Device: nelfilcon A
nelfilcon A, then somofilcon A	Experimental	Subjects will bilaterally wear the nelfilcon A lenses, then crossover to somofilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week. Receives: Device: somofilcon A; Device: nelfilcon A

What is being measured

The primary outcome is the main question the study is designed to answer.

Subjective Comfort at Lens Dispensing
Subjective comfort at lens dispensing on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Measured: Baseline (after 5 minutes of lens dispense)
Subjective Comfort at Start of Day
Subjective comfort at start of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Measured: 1 week
Subjective Comfort at End of Day
Subjective comfort at end of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Measured: 1 week
Overall Subjective Comfort
Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Measured: Baseline (after 5 minutes of lens dispense)
Overall Subjective Comfort
Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Measured: 1 week
Subjective Vision
Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.)
Measured: Baseline (after 5 minutes of lens dispense)
Subjective Vision
Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.)
Measured: 1 week

Secondary outcomes (14)

Biomicroscopy - Conjunctival Redness Score
Conjunctival redness - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
Measured: One Week
Biomicroscopy - Limbal Redness Score
Limbal redness - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
Measured: One week
Biomicroscopy - Corneal Staining Score
Corneal staining - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
Measured: One week
Biomicroscopy - Conjunctival Staining Score
Conjunctival staining - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
Measured: One week
Biomicroscopy - Papillary Conjunctivitis Score
Papillary conjunctivitis- slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
Measured: One week
Horizontal Centration - Lens Fit
Horizontal centration graded by -2 to 2 (-2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal).
Measured: Baseline (after 5 minutes of lens dispense)
Horizontal Centration - Lens Fit
Horizontal centration graded by -2 to 2 (-2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal).
Measured: One Week
Vertical Centration Grade - Lens Fit
Vertical centration graded by -2 to 2 (-2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior).
Measured: Baseline (after 5 minutes of lens dispense)
Vertical Centration Grade - Lens Fit
Vertical centration graded by -2 to 2 (-2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior).
Measured: One week
Corneal Coverage Grade
Corneal coverage graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).
Measured: Baseline (after 5 minutes of lens dispense)
Corneal Coverage Grade
Corneal coverage graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).
Measured: One week
Post-Blink Movement Grade
Post-blink movement graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).
Measured: Baseline (after 5 minutes of lens dispense)
Post-Blink Movement Grade
Post-blink movement graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).
Measured: 1 week
Ocular Redness Rating
Ocular redness rating rated on a scale 0-100 (0=extremely poor, intolerable levels of redness to 100 = excellent, no redness)
Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jul 201920 Nov 2019

First posted26 Aug 2019
Study start4 Jul 2019
Primary completion5 Nov 2019
Study completion20 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AmetropiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Model description: This is a bilateral crossover study
Masking: Single blind
Who is masked: Participant
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04067141
Sponsor's protocol ID: EX-MKTG-75
Status last verified: Nov 2020
First submitted: 21 Aug 2019
Last updated: 24 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison of Two Rotational Alignment Methods for Astigmatism Correction in SMILE Surgery
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The Impact of 'A Miss Is as Good as a Mile': Is Compensation Necessary for Minimal Ocular Deviation in Myopic Laser Surgery?
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Recruiting
Comparison of Low- Versus High-Level Angle Kappa Compensation Strategies in SMILE Using the VisuMax 800: A Randomized Clinical Trial
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A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses
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All Ametropia trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Clinical Comparison of the Clariti 1 Day and DAILIES AquaComfort PLUS Daily Disposable Contact Lenses
ClinicalTrials.gov ID: NCT04067141
Acronym / sponsor ID: EX-MKTG-75
Conditions: Ametropia
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 4 Jul 2019 (actual)
Primary completion: 5 Nov 2019 (actual)
Study completion: 20 Nov 2019 (actual)
First posted: 26 Aug 2019 (actual)
Results: Posted 24 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2
Model description: This is a bilateral crossover study

Arm	Type	Receives
somofilcon A, then nelfilcon A	Experimental	Device: somofilcon A, Device: nelfilcon ASubjects will bilaterally wear the somofilcon A lenses, then crossover to nelfilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week.
nelfilcon A, then somofilcon A	Experimental	Device: somofilcon A, Device: nelfilcon ASubjects will bilaterally wear the nelfilcon A lenses, then crossover to somofilcon A lenses after one week of wear. Both lenses will be worn on a daily wear basis for one week.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

They are of legal age (18) and capacity to volunteer.
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They agree not to participate in other clinical research for the duration of this study.
They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)

Key exclusion criteria (11 listed)

They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They have had cataract surgery.
They have had corneal refractive surgery.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
somofilcon AAlso: somofilcon A 1 day, test lens, clariti 1 dayContact Lens	Device	nelfilcon A, then somofilcon A, somofilcon A, then nelfilcon A
nelfilcon AAlso: nelfilcon A Daily Disposable Contact Lens, control lens, DAILIES AquaComfort PLUS daily disposableContact Lens	Device	nelfilcon A, then somofilcon A, somofilcon A, then nelfilcon A

Primary outcome

Subjective Comfort at Lens Dispensing
Time frame: Baseline (after 5 minutes of lens dispense)
Subjective comfort at lens dispensing on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Subjective Comfort at Start of Day
Time frame: 1 week
Subjective comfort at start of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Subjective Comfort at End of Day
Time frame: 1 week
Subjective comfort at end of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Overall Subjective Comfort
Time frame: Baseline (after 5 minutes of lens dispense)
Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Overall Subjective Comfort
Time frame: 1 week
Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Subjective Vision
Time frame: Baseline (after 5 minutes of lens dispense)
Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.)
Subjective Vision
Time frame: 1 week
Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.)

14 secondary outcomes

Biomicroscopy - Conjunctival Redness Score
Time frame: One Week
Biomicroscopy - Limbal Redness Score
Time frame: One week
Biomicroscopy - Corneal Staining Score
Time frame: One week
Biomicroscopy - Conjunctival Staining Score
Time frame: One week
Biomicroscopy - Papillary Conjunctivitis Score
Time frame: One week
Horizontal Centration - Lens Fit
Time frame: Baseline (after 5 minutes of lens dispense)
Horizontal Centration - Lens Fit
Time frame: One Week
Vertical Centration Grade - Lens Fit
Time frame: Baseline (after 5 minutes of lens dispense)
Vertical Centration Grade - Lens Fit
Time frame: One week
Corneal Coverage Grade
Time frame: Baseline (after 5 minutes of lens dispense)
Corneal Coverage Grade
Time frame: One week
Post-Blink Movement Grade
Time frame: Baseline (after 5 minutes of lens dispense)
Post-Blink Movement Grade
Time frame: 1 week
Ocular Redness Rating
Time frame: 1 week

Results and safety

Results posted to the registry on 24 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Somofilcon A, Then Nelfilcon A	35	35
Nelfilcon A, Then Somofilcon A	35	34

Primary outcome: Subjective Comfort at Lens Dispensing

Time frame: Baseline (after 5 minutes of lens dispense). Mean (Standard Deviation). Unit: units on a scale

Measure	Somofilcon A n = 69	Nelfilcon A n = 69
Value	90.9 (11.6)	88.5 (12.8)

Primary outcome: Subjective Comfort at Start of Day

Time frame: 1 week. Mean (Standard Deviation). Unit: units on a scale

Measure	Somofilcon A n = 67	Nelfilcon A n = 68
Value	89.9 (13.8)	87.0 (14.7)

Primary outcome: Subjective Comfort at End of Day

Time frame: 1 week. Mean (Standard Deviation). Unit: units on a scale

Measure	Somofilcon A n = 67	Nelfilcon A n = 68
Value	75.9 (22.1)	68.0 (25.5)

Primary outcome: Overall Subjective Comfort

Time frame: Baseline (after 5 minutes of lens dispense). Mean (Standard Deviation). Unit: units on a scale

Measure	Somofilcon A n = 69	Nelfilcon A n = 69
Value	90.4 (10.1)	90.9 (10.8)

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: From dispense up to 1 week on each study lens for a total of two weeks.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Somofilcon A	0 of 70 (0%)	2 of 70 (2.9%)	0 of 70
Nelfilcon A	0 of 70 (0%)	0 of 70 (0%)	0 of 70

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing somofilcon A and nelfilcon A in people with Ametropia, run by CooperVision, Inc. at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective Comfort at Lens Dispensing (time frame: Baseline (after 5 minutes of lens dispense)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04067141.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.