MyopiaNCT01707238

Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses

A study testing etafilcon A and stenfilcon A in people with Myopia, run by CooperVision, Inc. at 7 sites 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 purpose of this study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A. Read more about this study

Who is it for?: Ages 16 to 45 years
Conditions the study is for: Myopia
What is being tested?: etafilcon A and stenfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 7 sitesUnited Kingdom
Study dates: Oct 2012to Mar 2013
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 16 to 45 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Be between 16 and 45 years of age (inclusive)
Adapted soft contact lens (CL) wearers (i.e. > 1 month)
Spherical distance CL prescription between -1.00 and -6.00D (inclusive)
Spectacle cylinder ≤0.75D in the least astigmatic eye, ≤1.00D in the other.
Correctable to 6/9 (20/30) in both eyes
Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study.

Show all 9Show fewer

Have read, understood and signed the informed consent
Willing to comply with the wear schedule (at least 40 hours per week)
Willing to comply with the study visit schedule

Who cannot join

Any active corneal infection, injury or inflammation
Systemic or ocular allergies, which might interfere with CL wear
Systemic disease, which might interfere with CL wear
Ocular disease, which might interfere with CL wear
Strabismus, amblyopia
Subjects who have undergone corneal refractive surgery and any anterior segment surgery

Show all 12Show fewer

Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
Pregnant or lactating
Use of systemic/topical medication contraindicating CL wear
Use of gas permeable contact lenses within the last month
Employees of the investigational site or immediate family members of Investigators
Participation in any concurrent clinical trial or in the last 30 days

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United Kingdom7 sites

Keith Tempany Opticians
Broadstone, Dorset, MH18
Vision Express Optical Lab
Hendon, London, NW4 3FB
Cameron-Davies Optometrists
Portchester, Hants, PO16 9UN
David Gould Opticians
Rawtenstall, Lancashire, BB4 7QN
Cameron-Davies Optometrists
Southsea, Hampshire, PO5 2AT
Leightons Opticians
St Albans, Hertfordshire, AL1 3LH
S.H. Harrold
Uxbridge, London, UB8 1JX

Other trials in United Kingdom

About this study

The purpose of this study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A.

Read the detailed description

The study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A in this cross-over study.

Conditions: Myopia
Being tested: etafilcon 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.

etafilcon ADevice
Also called etafilcon A (Daily Disposable Contact Lens)
Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
stenfilcon ADevice
Also called stenfilcon A (Daily Disposable Contact Lens)
Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.

Study groups in NCT01707238
Study group	Role	What they receive
stenfilcon A	Experimental	Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. Receives: Device: etafilcon A
etafilcon A	Active comparator	Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. Receives: Device: stenfilcon A

What is being measured

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

Handling
Participant's subjective rating for lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10= very easy).
Measured: two weeks and four weeks from baseline visit
Satisfaction With Handling
Participant's subjective rating for overall satisfaction of lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).
Measured: two weeks and four weeks from baseline visit

Secondary outcomes (4)

Comfort
Participant's subjective rating for overall lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=can't feel).
Measured: two weeks and four weeks from baseline visit
Dryness
Participant's subjective rating for overall lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10=no dryness).
Measured: two weeks and four weeks from baseline visit
Satisfaction With Dryness
Participant's subjective rating for overall satisfaction of lens dryness of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).
Measured: two weeks and four weeks from baseline visit
Satisfaction With Comfort
Participant's subjective rating for overall satisfaction of lens comfort of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).
Measured: two weeks and four weeks from baseline visit

Timeline

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

Oct 2012Mar 2013

First posted16 Oct 2012 (estimated)
Study startOct 2012
Primary completionJan 2013
Study completionMar 2013

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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01707238
Sponsor's protocol ID: EX-MKTG-39
Status last verified: Jul 2020
First submitted: 21 Sep 2012
Last updated: 3 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses
ClinicalTrials.gov ID: NCT01707238
Acronym / sponsor ID: EX-MKTG-39
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Jan 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 16 Oct 2012 (estimated)
Results: Posted 27 Aug 2014

Clinical summary

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

The purpose of this study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A.

Detailed description

The study is to compare the subjective performance for handling of two daily disposable contact lenses, stenfilcon A and etafilcon A in this cross-over study.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
stenfilcon A	Experimental	Device: etafilcon AParticipants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
etafilcon A	Active comparator	Device: stenfilcon AParticipants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.

Who may qualify

Ages: 16 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (9 listed)

Be between 16 and 45 years of age (inclusive)
Adapted soft contact lens (CL) wearers (i.e. > 1 month)
Spherical distance CL prescription between -1.00 and -6.00D (inclusive)
Spectacle cylinder ≤0.75D in the least astigmatic eye, ≤1.00D in the other.
Correctable to 6/9 (20/30) in both eyes

Key exclusion criteria (12 listed)

Any active corneal infection, injury or inflammation
Systemic or ocular allergies, which might interfere with CL wear
Systemic disease, which might interfere with CL wear
Ocular disease, which might interfere with CL wear
Strabismus, amblyopia

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
etafilcon AAlso: etafilcon A (Daily Disposable Contact Lens)Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.	Device	stenfilcon A
stenfilcon AAlso: stenfilcon A (Daily Disposable Contact Lens)Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.	Device	etafilcon A

Primary outcome

Handling
Time frame: two weeks and four weeks from baseline visit
Participant's subjective rating for lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (0-10, 10= very easy).
Satisfaction With Handling
Time frame: two weeks and four weeks from baseline visit
Participant's subjective rating for overall satisfaction of lens handling of Pair #1 surveyed at 2 weeks (+3) days after baseline visit and Pair #2 surveyed at 4 weeks (+3) days after baseline visit. Each pair worn for two weeks daily disposable wear basis (at least 40 hours per week). Lenses worn minimum 2 hours prior to visit. Rated by questionnaires (5 point Likert scale - Completely Dissatisfied, Somewhat Dissatisfied, Neither, Somewhat Satisfied, Completely Satisfied).

4 secondary outcomes

Comfort
Time frame: two weeks and four weeks from baseline visit
Dryness
Time frame: two weeks and four weeks from baseline visit
Satisfaction With Dryness
Time frame: two weeks and four weeks from baseline visit
Satisfaction With Comfort
Time frame: two weeks and four weeks from baseline visit

Results and safety

Results posted to the registry on 27 Aug 2014, 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 Then Etafilcon A	48	48
Etafilcon A Then Stenfilcon A	52	52

Primary outcome: Handling

Time frame: two weeks and four weeks from baseline visit. Mean (Standard Deviation). Unit: units on a scale

Measure	Stenfilcon A n = 100	Etafilcon A n = 100
Value	8.84 (1.56)	6.76 (2.89)

Primary outcome: Satisfaction With Handling

Time frame: two weeks and four weeks from baseline visit. Number. Unit: percentage of participants

Measure	Stenfilcon A n = 100	Etafilcon A n = 100
Completely Satisfied	65 (0.85)	28 (1.37)
Somewhat Satisfied	22	31
Neither	8	13
Somwhat Dissatisfied	5	16
Completely Dissatisfied	0	12

4 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
Stenfilcon A	0 of 100 (0%)	0 of 100 (0%)	0 of 100
Etafilcon A	0 of 100 (0%)	0 of 100 (0%)	0 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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
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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.

Graeme Young study director

Visioncare Research Ltd.

Ruth Craven study director

Visioncare Research Ltd.

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

Questions about this trial

What is this clinical trial studying?

A study testing etafilcon A and stenfilcon A in people with Myopia, run by CooperVision, Inc. at 7 sites 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 9 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 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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 27 Aug 2014). 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?

Handling (time frame: two weeks and four weeks from baseline visit). The study lists 2 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 NCT01707238.

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 3 Aug 2020.