MyopiaNCT02643004

The Clinical Comparison of Senofilcon A and Stenfilcon A Contact Lenses

A study testing Senofilcon 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

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Trial summary

The objective of this study is to compare the clinical performance of senofilcon A lens with the stenfilcon A lens each for one week of daily disposable wear. 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?: Senofilcon A and Stenfilcon 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: Dec 2015to May 2016
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 (inclusive)

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They have a spectacle cylindrical correction of -0.75D or less in each eye.
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).

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.

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They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
They are pregnant or lactating.
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 MyDay (daily) or the Acuvue Oasys (2 weekly) 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

The objective of this study is to compare the clinical performance of senofilcon A lens with the stenfilcon A lens each for one week of daily disposable wear.

Read the detailed description

The purpose of this bilateral cross-over study is to evaluate the clinical performance of senofilcon A lens with the stenfilcon A lens. In particular, the study will focus on ocular physiology, lens fit, lens surface, visual acuity, and subjective response.

Conditions: Myopia
Being tested: Senofilcon 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.

Senofilcon ADevice
contact lens
Stenfilcon ADevice
contact lens

Study groups in NCT02643004
Study group	Role	What they receive
Senofilcon A	Active comparator	Participants were randomized to wear senofilcon A lens pair for one week during the crossover study. Receives: Device: Senofilcon A
Stenfilcon A	Active comparator	Participants were randomized to wear stenfilcon A lens pair for one week during the crossover 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 senofilcon A and stenfilcon A lenses by biomicroscopy for the following: corneal staining, conjunctival hyperaemia, limbal hyperaemia, and conjunctival staining. Scale 0-4, 0.25 steps, 0=normal, 4=severe.
Measured: Baseline and 1 week
Overall Subjective Score of Lenses
Subjective responses will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, 100=excellent.
Measured: Baseline and 1 week
Comfort
Subjective responses for comfort will be evaluated for each pair using questionnaire. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
Measured: Baseline and 1 week
Dryness
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
Subjective responses for vision will be evaluated for each pair using questionnaire. Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent.
Measured: Baseline and 1 week

Secondary outcomes (13)

Horizontal Centration
Lens fit, horizontal centration will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal
Measured: Baseline
Horizontal Centration
Lens fit, horizontal centration, will be assessed for senofilcon A and stenfilcon A at 1 week for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal
Measured: 1 Week
Vertical Centration
Lens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at baseline for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal
Measured: Baseline
Vertical Centration
Lens fit, vertical centration, will be assessed for senofilcon A and stenfilcon A at 1 week for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal
Measured: 1 Week
Lens Movement
Lens movement assessed for stenfilcon A and senofilcon A at baseline using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Measured: Baseline
Lens Movement
Lens movement assessed for stenfilcon A and senofilcon A at 1 week using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Measured: 1 Week
Visual Acuity
Measurement of visual acuity (VA) for senofilcon A and stenfilcon A assessed at baseline and 1 week using logMAR VA chart.
Measured: Baseline and 1 week
Lens Surface - Deposition
Lens surface for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Measured: Baseline
Lens Surface - Deposition
Lens surface for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Measured: 1 week
Lens Surface - Debris
Lens debris for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Measured: Baseline
Lens Surface - Debris
Lens debris for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Measured: 1 week
Lens Surface - Wettability
Lens wettability for senofilcon A and stenfilcon A is assessed at baseline. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Measured: Baseline
Lens Surface - Wettability
Lens wettability for senofilcon A and stenfilcon A is assessed at 1 week. Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Measured: 1 week

Timeline

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

Dec 2015May 2016

First posted30 Dec 2015 (estimated)
Study startDec 2015
Primary completionMar 2016
Study completionMay 2016

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: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02643004
Sponsor's protocol ID: EX-MKTG-62
Status last verified: Jul 2017
First submitted: 28 Dec 2015
Last updated: 23 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Clinical Comparison of Senofilcon A and Stenfilcon A Contact Lenses
ClinicalTrials.gov ID: NCT02643004
Acronym / sponsor ID: EX-MKTG-62
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Dec 2015
Primary completion: Mar 2016 (actual)
Study completion: May 2016 (actual)
First posted: 30 Dec 2015 (estimated)
Results: Posted 31 Mar 2017

Clinical summary

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

The objective of this study is to compare the clinical performance of senofilcon A lens with the stenfilcon A lens each for one week of daily disposable wear.

Detailed description

Study design

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

Arm	Type	Receives
Senofilcon A	Active comparator	Device: Senofilcon AParticipants were randomized to wear senofilcon A lens pair for one week during the crossover study.
Stenfilcon A	Active comparator	Device: Stenfilcon AParticipants were randomized to wear stenfilcon A lens pair for one week during the crossover study.

Who may qualify

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

Key inclusion criteria (10 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 (12 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
Senofilcon Acontact lens	Device	Senofilcon A
Stenfilcon Acontact lens	Device	Stenfilcon A

Primary outcome

Ocular Physiology
Time frame: Baseline and 1 week
Ocular physiology assessment of senofilcon A and stenfilcon A lenses by biomicroscopy for the following: corneal staining, conjunctival hyperaemia, limbal hyperaemia, and conjunctival staining. Scale 0-4, 0.25 steps, 0=normal, 4=severe.
Overall Subjective Score of Lenses
Time frame: Baseline and 1 week
Subjective responses will be evaluated for each pair using questionnaire. Scale 0-100, 0=extremely poor, 100=excellent.
Comfort
Time frame: Baseline and 1 week
Subjective responses for comfort will be evaluated for each pair using questionnaire. Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt.
Dryness
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
Time frame: Baseline and 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.

13 secondary outcomes

Horizontal Centration
Time frame: Baseline
Horizontal Centration
Time frame: 1 Week
Vertical Centration
Time frame: Baseline
Vertical Centration
Time frame: 1 Week
Lens Movement
Time frame: Baseline
Lens Movement
Time frame: 1 Week
Visual Acuity
Time frame: Baseline and 1 week
Lens Surface - Deposition
Time frame: Baseline
Lens Surface - Deposition
Time frame: 1 week
Lens Surface - Debris
Time frame: Baseline
Lens Surface - Debris
Time frame: 1 week
Lens Surface - Wettability
Time frame: Baseline
Lens Surface - Wettability
Time frame: 1 week

Results and safety

Results posted to the registry on 31 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Senofilcon A, Then Stenfilcon A	35	35
Stenfilcon A, Then Senofilcon A	35	35

Primary outcome: Ocular Physiology

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

Measure	Senofilcon A n = 70	Stenfilcon A n = 70
Baseline - Corneal staining	0.13 (0.30)	0.13 (0.30)
1 week - Corneal staining	0.21 (0.34)	0.15 (0.29)
Baseline - Conjunctival staining	0.21 (0.30)	0.21 (0.30)
1 week - Conjunctival staining	0.82 (0.51)	0.48 (0.43)
Baseline - Conjunctival hyperaemia	0.81 (0.23)	0.81 (0.23)
1 week - Conjunctival hyperaemia	0.82 (0.25)	0.86 (0.24)
Baseline - Limbal hyperaemia	0.70 (0.28)	0.70 (0.28)
1 week - Limbal hyperaemia	0.69 (0.26)	0.75 (0.26)

Population analysed: Protocol deviations occurred for 2 participants and therefore resulted in incomplete data sets.

Primary outcome: Overall Subjective Score of Lenses

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

Measure	Senofilcon A n = 70	Stenfilcon A n = 70
Baseline	92.3 (8.8)	89.4 (11.1)
1 week	87.0 (13.1)	80.0 (18.3)

Population analysed: A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.

Primary outcome: Comfort

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

Measure	Senofilcon A n = 70	Stenfilcon A n = 70
Baseline	90.8 (10.2)	90.5 (10.7)
1 week	87.0 (11.5)	82.1 (14.0)

Population analysed: A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.

Primary outcome: Dryness

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

Measure	Senofilcon A n = 70	Stenfilcon A n = 69
Value	82.3 (14.3)	77.7 (17.8)

Population analysed: A protocol deviation occurred for 1 participant and therefore resulted in incomplete data sets.

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Senofilcon A	0 of 70 (0%)	0 of 70 (0%)	Not reported
Stenfilcon A	0 of 70 (0%)	0 of 70 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

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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.

Carole Maldonado-Codinal, PhD principal investigator

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 Senofilcon 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 10 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 23 Aug 2017. 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 31 Mar 2017). 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: Baseline and 1 week). The study lists 5 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 NCT02643004.

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 23 Aug 2017.