MyopiaNCT02920970

The Clinical Comparison of Narafilcon A and Stenfilcon A Contact Lenses

A study testing narafilcon A and stenfilcon A in people with Myopia, 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

Search all trials

Trial 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 more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: narafilcon A and stenfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteUnited Kingdom
Study dates: 1 Sep 2016to 31 May 2017
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects will only be eligible for the study if:
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 (Diopters) (inclusive)

Show all 12Show fewer

They have a spectacle cylindrical correction of -0.75D or less in each eye.
They can be satisfactorily fitted with the study lens types.
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.
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 six days per week and for at least eight hours per day).
They own a wearable pair of spectacles.

Who cannot join

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

Show all 12Show fewer

They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
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 stenfilcon A lens or narafilcon A lens.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Eurolens Research - The University of Manchester
Manchester, M13 9PL

Other trials in United Kingdom

About this study

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.

Conditions: Myopia
Being tested: narafilcon A, stenfilcon A
Medical subject headings: Myopia

What participants receive

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

narafilcon ADevice
contact lens
stenfilcon ADevice
contact lens

Study groups in NCT02920970
Study group	Role	What they receive
narafilcon A	Active comparator	Participants are randomized to wear narafilcon A lens pair for one week during the cross over study. Receives: Device: narafilcon A
stenfilcon A	Active comparator	Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study. Receives: Device: stenfilcon A

What is being measured

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

Ocular Physiology
Ocular physiology assessment of narafilcon A and stenfilcon A lenses by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Measured: 1 week
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.
Measured: 1 week
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).
Measured: 1 week
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).
Measured: 1 week
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).
Measured: 1 week
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)
Measured: 1 week
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)
Measured: 1 week
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.
Measured: 1 week
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.
Measured: 1 week
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.
Measured: 1 week
Lens Movement
Lens movement assessed for narafilcon A and senofilcon A lenses and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Measured: 1 week

Timeline

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

1 Sep 201631 May 2017

First posted30 Sep 2016 (estimated)
Study start1 Sep 2016
Primary completion22 Dec 2016
Study completion31 May 2017

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 MyopiaStudies 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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02920970
Sponsor's protocol ID: EX-MKTG-71 (C16-601)
Status last verified: Jul 2018
First submitted: 29 Sep 2016
Last updated: 16 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Clinical Comparison of Narafilcon A and Stenfilcon A Contact Lenses
ClinicalTrials.gov ID: NCT02920970
Acronym / sponsor ID: EX-MKTG-71 (C16-601)
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 1 Sep 2016 (actual)
Primary completion: 22 Dec 2016 (actual)
Study completion: 31 May 2017 (actual)
First posted: 30 Sep 2016 (estimated)
Results: Posted 16 Jan 2019

Clinical summary

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

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
narafilcon A	Active comparator	Device: narafilcon AParticipants are randomized to wear narafilcon A lens pair for one week during the cross over study.
stenfilcon A	Active comparator	Device: stenfilcon AParticipants are randomized to wear stenfilcon A lens pair for one week during the cross over study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Subjects will only be eligible for the study if:

Key exclusion criteria (12 listed)

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

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
narafilcon Acontact lens	Device	narafilcon A
stenfilcon Acontact lens	Device	stenfilcon A

Primary outcome

Ocular Physiology
Time frame: 1 week
Ocular physiology assessment of narafilcon A and stenfilcon A lenses by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Visual Acuity
Time frame: 1 week
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.
Comfort Level of Stenfilcon A and Narafilcon A Lenses
Time frame: 1 week
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).
Dryness of Stenfilcon A and Narafilcon A Lenses
Time frame: 1 week
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).
Vision of Stenfilcon A and Narafilcon A Lenses
Time frame: 1 week
Subjective responses for vision will be evaluated for each pair using questionnaire (Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent).
Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses
Time frame: 1 week
Lens surface for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)
Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses
Time frame: 1 week
Lens wettability for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)
Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses
Time frame: 1 week
Horizontal centration assessed for narafilcon A and stenfilcon A lenses categorized as extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses
Time frame: 1 week
Vertical centration assessed for narafilcon A and stenfilcon A lenses and graded as extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.
Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses
Time frame: 1 week
Corneal coverage will be assessed for narafilcon A and stenfilcon A and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Lens Movement
Time frame: 1 week
Lens movement assessed for narafilcon A and senofilcon A lenses and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.

Results and safety

Results posted to the registry on 16 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stenfilcon A First Then Narafilcon A	38	38
Narafilcon A First Then Stenfilcon A	32	30

Primary outcome: Ocular Physiology

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

Measure	Stenfilcon A n = 68	Narafilcon A n = 65
Conjuctival hyperaemia	0.84 (0.25)	0.76 (0.27)
Limbal hyperaemia	0.75 (0.28)	0.62 (0.31)
Corneal vascularisation	0.05 (0.14)	0.03 (0.09)
Microcysts	0.00 (0.00)	0.00 (0.00)
Oedema	0.00 (0.00)	0.00 (0.00)
Corneal staining	0.31 (0.41)	0.33 (0.40)
Conjuctival staining	0.57 (0.49)	0.76 (0.64)
Papillary conjuctivitis	1.01 (0.35)	1.00 (0.31)

Population analysed: There were 2 participants excluded from the analysis for narafilcon A due to protocol deviations

Primary outcome: Visual Acuity

Time frame: 1 week. Mean (Standard Deviation). Unit: LogMAR

Measure	Stenfilcon A n = 68	Narafilcon A n = 65
High Contrast	-0.12 (0.07)	-0.10 (0.08)
Low Contrast	0.17 (0.09)	0.17 (0.10)

Population analysed: There were 2 participants excluded from the analysis for narafilcon A at follow up due to protocol deviations.

Primary outcome: Comfort Level of Stenfilcon A and Narafilcon A Lenses

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

Measure	Stenfilcon A n = 68	Narafilcon A n = 65
Value	91.4 (9.8)	83.1 (14.8)

Population analysed: There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations

Primary outcome: Dryness of Stenfilcon A and Narafilcon A Lenses

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

Measure	Stenfilcon A n = 68	Narafilcon A n = 65
Value	82.1 (17.2)	81.2 (16.7)

Population analysed: There were 2 participants excluded from the analysis for narafilcon A due to protocol deviations

Adverse events

Time frame: 1 week. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stenfilcon A	0 of 70 (0%)	2 of 70 (2.9%)	0 of 70
Narafilcon A	0 of 70 (0%)	6 of 70 (8.6%)	0 of 70

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

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.

Philip Morgan, PhD, FAAO, FBCLA study director

Eurolens Research, University of Manchester

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

Questions about this trial

What is this clinical trial studying?

A study testing narafilcon A and stenfilcon A in people with Myopia, 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 12 inclusion and 12 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 16 Jan 2019. 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 16 Jan 2019). 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?

Ocular Physiology (time frame: 1 week). The study lists 11 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 NCT02920970.

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 16 Jan 2019.