MyopiaNCT02759471

One Month Dispensing Study Comparing the Clinical Performance of the Comfilcon A Sphere Lenses Compared to Comfilcon A Asphere Lenses.

A study testing comfilcon A asphere lens (test) in people with Myopia, run by CooperVision, Inc. at 4 sites in United States.

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 is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens (control) following a refit with comfilcon A asphere lens (test). Read more about this study

Who is it for?: Ages 18 to 34 yearsHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: comfilcon A asphere lens (test)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 4 sitesUnited States
Study dates: Apr 2016to Aug 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 to 34 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

A person is eligible for inclusion in the study if he/she:
Is between 18 and 34 years of age (inclusive)
Has had a self-reported eye exam in the last two years
Is an adapted comfilcon A sphere contact lens wearer
Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week.
Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)

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Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye.
Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
Has clear corneas and no active ocular disease
Has read, understood and signed the information consent letter.
Has a contact lens refraction that fits within the available parameters of the study lenses.
Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
Is willing to comply with the visit schedule

Who cannot join

A person will be excluded from the study if he/she:
Has a history of not achieving comfortable CL (Contact Lens) wear (5 days per week; > 8 hours/day)
Presents with clinically significant anterior segment abnormalities
Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear.
Presents with slit lamp findings that would contraindicate contact lens wear such as:
Pathological dry eye or associated findings

Show all 19Show fewer

Significant pterygium, pinguecula, or corneal scars within the visual axis
Neovascularization > 0.75 mm in from of the limbus
Giant papillary conjunctivitis (GCP) worse than grade 1
Anterior uveitis or iritis (or history in past year)
Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
History of corneal ulcers or fungal infections
Poor personal hygiene
Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
Has aphakia, keratoconus or a highly irregular cornea.
Has presbyopia or has dependence on spectacles for near work over the contact lenses.
Has undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.
Is habitually using rewetting/ lubricating eye drops (more than once per day)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Drs. Quinn, Foster, & Associates
Athens, Ohio, 45701
Complete Eye Care of Medina
Medina, Minnesota, 55340
Sacco Eye Group
Vestal, New York, 13850
Golden Optometric Group
Whittier, California, 90606

Other trials in United States

About this study

Read the detailed description

Both comfilcon A sphere lens (control) and comfilcon A asphere lens (test) are Coopervison lenses.

Conditions: Myopia
Being tested: comfilcon A sphere lens (control), comfilcon A asphere lens (test)
Medical subject headings: Myopia

What participants receive

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

comfilcon A sphere lens (control)Device
contact lens
comfilcon A asphere lens (test)Device
contact lens

Study groups in NCT02759471
Study group	Role	What they receive
comfilcon A asphere (test)	Experimental	Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test). Receives: Device: comfilcon A asphere lens (test)
comfilcon A sphere (control)	Active comparator	Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test). Receives: Device: comfilcon A sphere lens (control)

What is being measured

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

Lens Fit - Centration
Lens fit evaluation of centration for comfilcon A sphere and comfilcon A asphere lens. (Scale: optimum, decentration acceptable and decentration unacceptable).
Measured: baseline, 2 weeks, 1 month
Lens Fit - Corneal Coverage
Lens fit evaluation of corneal coverage for comfilcon A sphere and comfilcon A asphere lens. ('yes' - full coverage, or 'no' - incomplete corneal coverage).
Measured: baseline, 2 weeks, 1 month
Lens Fit - Post-blink Movement
Lens fit evaluation of post-blink movement for comfilcon A sphere and comfilcon A asphere lens. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Measured: baseline, 2 weeks, 1 month
Lens Preference/Acceptability
Investigators preference/acceptability for comfilcon A sphere and comfilcon A asphere lenses. (Choices: strongly prefer study lenses, slightly prefer study lenses, slightly prefer habitual lenses, strongly prefer habitual lenses).
Measured: baseline, 2 weeks, 1 month

Timeline

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

Apr 2016Aug 2016

First posted3 May 2016 (estimated)
Study startApr 2016
Primary completionJun 2016
Study completionAug 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: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02759471
Sponsor's protocol ID: EX-MKTG-63
Status last verified: Jul 2020
First submitted: 29 Apr 2016
Last updated: 29 Jul 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 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: One Month Dispensing Study Comparing the Clinical Performance of the Comfilcon A Sphere Lenses Compared to Comfilcon A Asphere Lenses.
ClinicalTrials.gov ID: NCT02759471
Acronym / sponsor ID: EX-MKTG-63
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2016
Primary completion: Jun 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 3 May 2016 (estimated)
Results: Posted 23 Feb 2017

Clinical summary

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

Detailed description

Both comfilcon A sphere lens (control) and comfilcon A asphere lens (test) are Coopervison lenses.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
comfilcon A asphere (test)	Experimental	Device: comfilcon A asphere lens (test)Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).
comfilcon A sphere (control)	Active comparator	Device: comfilcon A sphere lens (control)Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).

Who may qualify

Ages: 18 to 34 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Is between 18 and 34 years of age (inclusive)
Has had a self-reported eye exam in the last two years
Is an adapted comfilcon A sphere contact lens wearer
Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week.
Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)

Key exclusion criteria (19 listed)

Has a history of not achieving comfortable CL (Contact Lens) wear (5 days per week; > 8 hours/day)
Presents with clinically significant anterior segment abnormalities
Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear.
Presents with slit lamp findings that would contraindicate contact lens wear such as:
Has a known history of corneal hypoesthesia (reduced corneal sensitivity)

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
comfilcon A sphere lens (control)contact lens	Device	comfilcon A sphere (control)
comfilcon A asphere lens (test)contact lens	Device	comfilcon A asphere (test)

Primary outcome

Lens Fit - Centration
Time frame: baseline, 2 weeks, 1 month
Lens fit evaluation of centration for comfilcon A sphere and comfilcon A asphere lens. (Scale: optimum, decentration acceptable and decentration unacceptable).
Lens Fit - Corneal Coverage
Time frame: baseline, 2 weeks, 1 month
Lens fit evaluation of corneal coverage for comfilcon A sphere and comfilcon A asphere lens. ('yes' - full coverage, or 'no' - incomplete corneal coverage).
Lens Fit - Post-blink Movement
Time frame: baseline, 2 weeks, 1 month
Lens fit evaluation of post-blink movement for comfilcon A sphere and comfilcon A asphere lens. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Lens Preference/Acceptability
Time frame: baseline, 2 weeks, 1 month
Investigators preference/acceptability for comfilcon A sphere and comfilcon A asphere lenses. (Choices: strongly prefer study lenses, slightly prefer study lenses, slightly prefer habitual lenses, strongly prefer habitual lenses).

Results and safety

Results posted to the registry on 23 Feb 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
Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)	54	52

Primary outcome: Lens Fit - Centration

Time frame: baseline, 2 weeks, 1 month. Number. Unit: participants

Measure	Comfilcon A Sphere (Control) n = 52	Comfilcon A Asphere (Test) n = 52
Baseline, Optimum	48	46
Baseline, Acceptable	4	6
Baseline, Unacceptable	0	0
At 2 weeks, optimum	NA	45
At 2 weeks, acceptable	NA	6
At 2 weeks, unacceptable	NA	0
At 1 month, optimum	NA	46
At 1 month, acceptable	NA	5

Population analysed: One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.

Primary outcome: Lens Fit - Corneal Coverage

Time frame: baseline, 2 weeks, 1 month. Number. Unit: participants

Measure	Comfilcon A Sphere (Control) n = 52	Comfilcon A Asphere (Test) n = 52
Baseline, yes	52	52
2 weeks, yes	51	51
1 month, yes	51	51

Population analysed: One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.

Primary outcome: Lens Fit - Post-blink Movement

Time frame: baseline, 2 weeks, 1 month. Mean (Standard Deviation). Unit: units on a scale

Measure	Comfilcon A Sphere (Control) n = 52	Comfilcon A Asphere (Test) n = 52
Baseline	1.9 (0.6)	1.9 (0.3)
After 2 weeks	NA (NA)	1.9 (0.4)
After 1 month	NA (NA)	1.9 (0.5)

Population analysed: One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.

Primary outcome: Lens Preference/Acceptability

Time frame: baseline, 2 weeks, 1 month. Number. Unit: participants

Measure	Investigator Rating of Fit Preference n = 52
Strongly prefer comfilcon A asphere	5
Slightly prefer comfilcon A asphere	39
Strongly prefer comfilcon A sphere	8
Slightly prefer comfilcon A sphere	0

Adverse events

Time frame: 4 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)	0 of 52 (0%)	0 of 52 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Andrew Sacco, OD principal investigator

Sacco Eye Group

Gina Wesley, OD principal investigator

Complete Eye Care of Medina

Thomas Quinn, OD, MS, FAAO principal investigator

Drs. Quinn, Foster, & Associates

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

Questions about this trial

What is this clinical trial studying?

A study testing comfilcon A asphere lens (test) in people with Myopia, run by CooperVision, Inc. at 4 sites in United States.

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 19 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 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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 23 Feb 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?

Lens Fit - Centration (time frame: baseline, 2 weeks, 1 month). The study lists 4 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 NCT02759471.

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 29 Jul 2020.