MyopiaNCT01808209

Clinical Performance of Stenfilcon A Versus Filcon II 3

A study testing stenfilcon A and filcon II 3 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

Clinical Performance of Stenfilcon vs. Filcon II 3 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia
What is being tested?: stenfilcon A and filcon II 3
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited Kingdom
Study dates: Jan 2013to May 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must satisfy the following conditions prior to inclusion in the study:
Based on his/her knowledge, must be in good general health. Be of legal age (18 years) or older.
Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
Read, indicate understanding of, and sign Written Informed Consent (Appendix 1)
Require a contact lens prescription between -0.50 and -6.00 and have no more than -.75dioptor (D) of astigmatism in both eyes
Achieve visual acuity of 6/9 or better in each eye with a spherical contact lens prescription.

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An existing soft contact lens wearer of any modality.
Must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per day, assuming there are no contraindications for doing so.
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
No amblyopia.
No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes).
No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings greater than Grade 2: corneal edema, tarsal abnormalities, and conjunctival injection).
No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology.)
No aphakia

Who cannot join

Any of the following will render a subject ineligible for inclusion:
Neophytes, who have not worn lenses before
Greater than 0.75D of refractive astigmatism in either eye
Presence of clinically significant (grade 3 or above) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.
Slit lamp findings that would contraindicate contact lens wear such as:

Show all 17Show fewer

Pathological dry eye or associated findings
Pterygium, pinguecula or corneal scars within the visual axis
Neovascularization > 0.75 mm in from the limbus
Giant papillary conjunctivitis (GPC) Grade 3 or above
Anterior uveitis or iritis (past or present)
Seborrheic eczema, seborrheic conjunctivitis
History of corneal ulcer or fungal infections
Poor personal hygiene
A known history of corneal hypoesthesia (reduced corneal sensitivity).
Contact lens best corrected Snellen visual acuities (VA) worse than 6/9
Aphakia, Keratoconus or a highly irregular cornea

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

University of Aston
Birmingham, West Midlands, B4 7ET

Other trials in United Kingdom

About this study

Clinical Performance of Stenfilcon vs. Filcon II 3

Read the detailed description

The objective of this study is to compare the comfort and clinical performance of Stenfilcon vs. Filcon II 3 compared to subject's habitual contact lenses. The null hypothesis is that there is no difference in the clinical performance between the two sets of lenses.

Conditions: Myopia
Being tested: stenfilcon A, filcon II 3
Medical subject headings: Myopia

What participants receive

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

stenfilcon ADevice
Also called stenfilcon A (Daily Disposable Contact Lens)
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
filcon II 3Device
Also called filcon II 3 (Daily Disposable Contact Lens)
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.

Study groups in NCT01808209
Study group	Role	What they receive
stenfilcon A	Experimental	Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week. Receives: Device: filcon II 3
filcon II 3	Active comparator	Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week. Receives: Device: stenfilcon A

What is being measured

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

Daily and Comfortable Wearing Time
Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses.(The hours of average comfortable wearing time and average daily wearing time.)
Measured: Baseline
Daily and Comfortable Wearing Time
Participant rating of lens Daily and Comfortable Wearing Time. Collected at 1 week wear for each lens.(The hours of average comfortable wearing time and average daily wearing time.)
Measured: 1 week
Handling
Participant rating for lens handling. Collected at 1 week. (Insertion: 0-100, 0= could not get it in and 100= went in without a problem. Removal: 0= could not get it out and 100= came out without a problem. Blister: 0=impossible and 100=came out extremely easily).
Measured: 1 Week
Comfort
Participant rating of lens comfort. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable,100=extreme comfort / cannot feel them at all)
Measured: Baseline
Comfort
Participant rating for comfort. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).
Measured: 1 Week
Dryness
Participant rating of lens dryness. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable, 100=extreme comfort/ cannot feel them at all)
Measured: Baseline
Dryness
Participant rating for dryness. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).
Measured: 1 Week
Vision Quality
Participant rating of vision quality. Collected at baseline for habitual lens. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)
Measured: Baseline
Vision Quality
Participant rating of vision quality. Collected at 1 week. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)
Measured: 1 Week
Eye Whiteness
Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).
Measured: Baseline
Eye Whiteness
Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).
Measured: 1 Week
Overall Satisfaction
Participant rating for overall satisfaction. Collected at baseline for habitual lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).
Measured: Baseline
Overall Satisfaction
Participant rating for overall satisfaction. Collected at 1 week for study lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).
Measured: 1 Week
Visual Acuity logMAR
Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at baseline for habitual lens. logMAR.
Measured: Baseline
Visual Acuity logMAR
Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at dispense for study lenses. logMAR.
Measured: Dispense
Visual Acuity logMAR
Assessment of Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at 1 week for study lenses. logMAR
Measured: 1 Week
Wettability
Participant rating for surface wettability. Collected at 1 week. Tear film analysis in seconds.
Measured: 1 Week

Secondary outcomes (7)

Blood Vessel Coverage
Assessment of ocular health. Collected at baseline after removal of lenses. Percent of blood vessel coverage.
Measured: Baseline
Blood Vessel Coverage
Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of blood vessel coverage.
Measured: 1 Week
Conjunctival Redness
Assessment of ocular health. Collected at baseline after removal of lenses. Percentage of conjunctival redness.
Measured: Baseline
Conjunctival Redness
Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of conjunctival redness.
Measured: 1 Week
Corneal Staining
Assessment of ocular health. Collected at baseline after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )
Measured: Baseline
Corneal Staining
Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )
Measured: 1 Week
Conjunctival Staining
Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 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.

Jan 2013May 2013

First posted11 Mar 2013 (estimated)
Study startJan 2013
Primary completionApr 2013
Study completionMay 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: Single blind
Who is masked: Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01808209
Sponsor's protocol ID: EX-MKTG-40
Status last verified: Jul 2020
First submitted: 14 Feb 2013
Last updated: 3 Aug 2020
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 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Performance of Stenfilcon A Versus Filcon II 3
ClinicalTrials.gov ID: NCT01808209
Acronym / sponsor ID: EX-MKTG-40
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2013
Primary completion: Apr 2013 (actual)
Study completion: May 2013 (actual)
First posted: 11 Mar 2013 (estimated)
Results: Posted 19 Jan 2015

Clinical summary

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

Clinical Performance of Stenfilcon vs. Filcon II 3

Detailed description

Study design

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

Arm	Type	Receives
stenfilcon A	Experimental	Device: filcon II 3Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
filcon II 3	Active comparator	Device: stenfilcon AParticipants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses 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 (14 listed)

Based on his/her knowledge, must be in good general health. Be of legal age (18 years) or older.
Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
Read, indicate understanding of, and sign Written Informed Consent (Appendix 1)
Require a contact lens prescription between -0.50 and -6.00 and have no more than -.75dioptor (D) of astigmatism in both eyes
Achieve visual acuity of 6/9 or better in each eye with a spherical contact lens prescription.

Key exclusion criteria (17 listed)

Neophytes, who have not worn lenses before
Greater than 0.75D of refractive astigmatism in either eye
Presence of clinically significant (grade 3 or above) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.
Slit lamp findings that would contraindicate contact lens wear such as:

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
stenfilcon AAlso: stenfilcon A (Daily Disposable Contact Lens)Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.	Device	filcon II 3
filcon II 3Also: filcon II 3 (Daily Disposable Contact Lens)Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.	Device	stenfilcon A

Primary outcome

Daily and Comfortable Wearing Time
Time frame: Baseline
Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses.(The hours of average comfortable wearing time and average daily wearing time.)
Daily and Comfortable Wearing Time
Time frame: 1 week
Participant rating of lens Daily and Comfortable Wearing Time. Collected at 1 week wear for each lens.(The hours of average comfortable wearing time and average daily wearing time.)
Handling
Time frame: 1 Week
Participant rating for lens handling. Collected at 1 week. (Insertion: 0-100, 0= could not get it in and 100= went in without a problem. Removal: 0= could not get it out and 100= came out without a problem. Blister: 0=impossible and 100=came out extremely easily).
Comfort
Time frame: Baseline
Participant rating of lens comfort. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable,100=extreme comfort / cannot feel them at all)
Comfort
Time frame: 1 Week
Participant rating for comfort. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).
Dryness
Time frame: Baseline
Participant rating of lens dryness. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable, 100=extreme comfort/ cannot feel them at all)
Dryness
Time frame: 1 Week
Participant rating for dryness. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).
Vision Quality
Time frame: Baseline
Participant rating of vision quality. Collected at baseline for habitual lens. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)
Vision Quality
Time frame: 1 Week
Participant rating of vision quality. Collected at 1 week. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)
Eye Whiteness
Time frame: Baseline
Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).
Eye Whiteness
Time frame: 1 Week
Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).
Overall Satisfaction
Time frame: Baseline
Participant rating for overall satisfaction. Collected at baseline for habitual lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).
Overall Satisfaction
Time frame: 1 Week
Participant rating for overall satisfaction. Collected at 1 week for study lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).
Visual Acuity logMAR
Time frame: Baseline
Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at baseline for habitual lens. logMAR.
Visual Acuity logMAR
Time frame: Dispense
Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at dispense for study lenses. logMAR.
Visual Acuity logMAR
Time frame: 1 Week
Assessment of Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at 1 week for study lenses. logMAR
Wettability
Time frame: 1 Week
Participant rating for surface wettability. Collected at 1 week. Tear film analysis in seconds.

7 secondary outcomes

Blood Vessel Coverage
Time frame: Baseline
Blood Vessel Coverage
Time frame: 1 Week
Conjunctival Redness
Time frame: Baseline
Conjunctival Redness
Time frame: 1 Week
Corneal Staining
Time frame: Baseline
Corneal Staining
Time frame: 1 Week
Conjunctival Staining
Time frame: 1 Week

Results and safety

Results posted to the registry on 19 Jan 2015, 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 Filcon II 3	33	33
Filcon II 3 Then Stenfilcon A	27	26

Primary outcome: Daily and Comfortable Wearing Time

Time frame: Baseline. Mean (Standard Deviation). Unit: hours

Measure	Overall Study Group n = 59
Average Wearing Time	9.8 (3.1)
Average Comfortable Wearing Time	7.7 (3.4)

Primary outcome: Daily and Comfortable Wearing Time

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

Measure	Stenfilcon A n = 59	Filcon II 3 n = 59
Average Wearing Time	11.4 (2.6)	10.8 (2.6)
Average Comfortable Wearing Time	8.7 (3.0)	8.7 (2.8)

Population analysed: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.

Primary outcome: Handling

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

Measure	Stenfilcon A n = 59	Filcon II 3 n = 59
From Blister	90.8 (11.7)	92.2 (0.32)
Inside Out	84.9 (24.6)	86.4 (25.9)
Insertion	93.4 (10.7)	89.3 (13.0)
Removal	90.0 (13.6)	92.0 (11.3)

Population analysed: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.

Primary outcome: Comfort

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

Measure	Habitual Lens n = 59
On Insertion	85.0 (17.0)
After 4 Hours	91.8 (9.1)
After 8 Hours	80.8 (15.7)
On Removal	75.3 (19.7)

Population analysed: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From dispense up to one week for each pair of lenses.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stenfilcon A	0 of 60 (0%)	0 of 60 (0%)	Not reported
Filcon II 3	0 of 60 (0%)	0 of 60 (0%)	Not reported

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

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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.

James Wolffsohn, PhD principal investigator

University of Aston Birmingham, West Midlands, United Kingdom

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

Questions about this trial

What is this clinical trial studying?

A study testing stenfilcon A and filcon II 3 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 14 inclusion and 17 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 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 19 Jan 2015). 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?

Daily and Comfortable Wearing Time (time frame: Baseline). The study lists 17 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 NCT01808209.

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.