MyopiaNCT02920957

Performance Comparison Between Comfilcon A and Senofilcon C Lenses

A study testing comfilcon A and senofilcon C in people with Myopia, run by CooperVision, Inc. at 5 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

The aim of this study is to determine the clinical performance of comfilcon A in comparison to senofilcon C. 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 and senofilcon C
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 5 sitesUnited States
Study dates: Sep 2016to 23 Nov 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 a spherical soft contact lens wearer
Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)
Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye.

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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 prescription that fits within the available parameters of the study lenses.
Is willing and anticipated to be able to comply with the wear schedule (at least 6 days per week, 12 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 (defined as 6 days per week; > 10 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

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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
Is currently wearing daily disposable lenses

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Cornea & Contact Lens Institute of Minnesota
Edina, Minnesota, 55436
Vision Professionals
New Albany, Ohio, 43054
Coan Eye Care & Optical Boutique
Ocoee, Florida, 34761
Sacco Eye Group
Vestal, New York, 13850
Golden Optometric Group
Whittier, California, 90606

Other trials in United States

About this study

The aim of this study is to determine the clinical performance of comfilcon A in comparison to senofilcon C.

Read the detailed description

This is a prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, two month dispensing study comparing the clinical performance of comfilcon A and senofilcon C lenses after one month of wear.

Conditions: Myopia
Being tested: comfilcon A, senofilcon C
Medical subject headings: Myopia

What participants receive

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

comfilcon ADevice
contact lens
senofilcon CDevice
contact lens

Study groups in NCT02920957
Study group	Role	What they receive
comfilcon A	Active comparator	Participants are randomized to wear the comfilcon A lens for one month during the cross over study. Receives: Device: comfilcon A
senofilcon C	Active comparator	Participants are randomized to wear the senofilcon C lens for one month during the cross over study. Receives: Device: senofilcon C

What is being measured

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

Overall Lens Fit Acceptance
Investigator fit acceptability for comfilcon A and senofilcon C lenses. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect.
Measured: Up to 1 month
Corneal Coverage
Corneal coverage for comfilcon A and senofilcon C lenses. (yes/no)
Measured: Up to 1 month
Lens Centration
Lens centration for comfilcon A and senofilcon C lenses. (optimum/ decentration acceptable/ decentration unacceptable)
Measured: Up to 1 month
Post-blink Movement
Post-blink movement for comfilcon A and senofilcon C lenses. Scale 0-4, (1 step size) (0=Insufficient, 4=Excessive, unacceptable movement)
Measured: Up to 1 month
Lens Lag at Primary Gaze
Lens lag at primary gaze for comfilcon A and senofilcon C lenses. (mm, 0.1 step size)
Measured: Up to 1 month
Tightness on Push up
Tightness on push up for comfilcon A and senofilcon C lenses. Scale 0%-100%, 0%=falls from cornea, 50%=optimum, 100%=no movement)
Measured: Up to 1 month
Lens Wettability
Lens wettability for comfilcon A and senofilcon C lenses. Scale 0-4, (0.5 step size) (0=very poor, 4=excellent)
Measured: Up to 1 month
Deposit Grading
Deposit grading for comfilcon A and senofilcon C lenses. Scale 0-4 (0.5 step size) (0=no deposits, 4=severe deposits)
Measured: Up to 1 month

Timeline

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

Sep 201623 Nov 2016

First posted30 Sep 2016 (estimated)
Study startSep 2016
Primary completion23 Nov 2016
Study completion23 Nov 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02920957
Sponsor's protocol ID: EX-MKTG-70
Status last verified: Dec 2017
First submitted: 29 Sep 2016
Last updated: 9 Jan 2018
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

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance Comparison Between Comfilcon A and Senofilcon C Lenses
ClinicalTrials.gov ID: NCT02920957
Acronym / sponsor ID: EX-MKTG-70
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2016
Primary completion: 23 Nov 2016 (actual)
Study completion: 23 Nov 2016 (actual)
First posted: 30 Sep 2016 (estimated)
Results: Posted 9 Jan 2018

Clinical summary

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

The aim of this study is to determine the clinical performance of comfilcon A in comparison to senofilcon C.

Detailed description

Study design

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

Arm	Type	Receives
comfilcon A	Active comparator	Device: comfilcon AParticipants are randomized to wear the comfilcon A lens for one month during the cross over study.
senofilcon C	Active comparator	Device: senofilcon CParticipants are randomized to wear the senofilcon C lens for one month during the cross over study.

Who may qualify

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

Key inclusion criteria (13 listed)

Is between 18 and 34 years of age (inclusive)
Has had a self-reported eye exam in the last two years
Is a spherical soft contact lens wearer
Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)
Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye.

Key exclusion criteria (20 listed)

Has a history of not achieving comfortable CL (contact lens) wear (defined as 6 days per week; > 10 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 Acontact lens	Device	comfilcon A
senofilcon Ccontact lens	Device	senofilcon C

Primary outcome

Overall Lens Fit Acceptance
Time frame: Up to 1 month
Investigator fit acceptability for comfilcon A and senofilcon C lenses. Scale 0-4, 0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect.
Corneal Coverage
Time frame: Up to 1 month
Corneal coverage for comfilcon A and senofilcon C lenses. (yes/no)
Lens Centration
Time frame: Up to 1 month
Lens centration for comfilcon A and senofilcon C lenses. (optimum/ decentration acceptable/ decentration unacceptable)
Post-blink Movement
Time frame: Up to 1 month
Post-blink movement for comfilcon A and senofilcon C lenses. Scale 0-4, (1 step size) (0=Insufficient, 4=Excessive, unacceptable movement)
Lens Lag at Primary Gaze
Time frame: Up to 1 month
Lens lag at primary gaze for comfilcon A and senofilcon C lenses. (mm, 0.1 step size)
Tightness on Push up
Time frame: Up to 1 month
Tightness on push up for comfilcon A and senofilcon C lenses. Scale 0%-100%, 0%=falls from cornea, 50%=optimum, 100%=no movement)
Lens Wettability
Time frame: Up to 1 month
Lens wettability for comfilcon A and senofilcon C lenses. Scale 0-4, (0.5 step size) (0=very poor, 4=excellent)
Deposit Grading
Time frame: Up to 1 month
Deposit grading for comfilcon A and senofilcon C lenses. Scale 0-4 (0.5 step size) (0=no deposits, 4=severe deposits)

Results and safety

Results posted to the registry on 9 Jan 2018, 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 First Then Senofilcon C	46	42
Senofilcon C First Then Comfilcon A	41	41

Primary outcome: Overall Lens Fit Acceptance

Time frame: Up to 1 month. Mean (Standard Deviation). Unit: units on a scale

Measure	Comfilcon A at Dispense n = 85	Comfilcon A After 2 Weeks n = 84	Comfilcon A After 1 Month n = 82	Senofilcon C at Dispense n = 83	Senofilcon C After 2 Weeks n = 82	Senofilcon C After 1 Month n = 83
Value	3.6 (0.5)	3.5 (0.6)	3.5 (0.7)	3.5 (0.7)	3.5 (0.6)	3.3 (0.8)

Population analysed: Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.

Primary outcome: Corneal Coverage

Time frame: Up to 1 month. Number. Unit: participants

Measure	Comfilcon A at Dispense n = 85	Comfilcon A After 2 Weeks n = 84	Comfilcon A After 1 Month n = 82	Senofilcon C at Dispense n = 83	Senofilcon C After 2 Weeks n = 82	Senofilcon C After 1 Month n = 83
Yes	85	84	82	83	82	83
No	0	0	0	0	0	0

Population analysed: Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.

Primary outcome: Lens Centration

Time frame: Up to 1 month. Number. Unit: participants

Measure	Comfilcon A at Dispense n = 85	Comfilcon A After 2 Weeks n = 84	Comfilcon A After 1 Month n = 82	Senofilcon C at Dispense n = 83	Senofilcon C After 2 Weeks n = 82	Senofilcon C After 1 Month n = 83
Optimum	77	78	76	71	71	76
Acceptable	7	6	5	11	10	5
Unacceptable	1	0	1	1	1	2

Population analysed: Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.

Primary outcome: Post-blink Movement

Time frame: Up to 1 month. Mean (Standard Deviation). Unit: units on a scale

Measure	Comfilcon A at Dispense n = 85	Comfilcon A After 2 Weeks n = 84	Comfilcon A After 1 Month n = 82	Senofilcon C at Dispense n = 83	Senofilcon C After 2 Weeks n = 82	Senofilcon C After 1 Month n = 83
Value	1.8 (0.5)	1.9 (0.5)	1.9 (0.5)	1.9 (0.6)	1.9 (0.4)	1.8 (0.6)

Population analysed: Analysis numbers differ from baseline due to protocol deviation and exclusion of subjects lost after only 1 visit.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Comfilcon A	1 of 87 (1.1%)	0 of 87 (0%)	Not reported
Senofilcon C	0 of 83 (0%)	0 of 83 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Lyndon Jones, PhD, FAAO, FIACLE, FBCLA study director

Centre for Contact Lens Research

5 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 and senofilcon C in people with Myopia, run by CooperVision, Inc. at 5 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 13 inclusion and 20 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 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 9 Jan 2018). 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?

Overall Lens Fit Acceptance (time frame: Up to 1 month). The study lists 8 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 NCT02920957.

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 9 Jan 2018.