MyopiaNCT02185105

Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses

A study testing comfilcon A MTO and comfilcon A in people with Myopia and Astigmatism, run by CooperVision, Inc. at 1 site 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 study hypothesis is there is no difference in the clinical performance between the test and control lenses, in particular in lens stability, toric mislocation, comfort ratings and anterior segment ocular health findings. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia, Astigmatism
What is being tested?: comfilcon A MTO and comfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Jun 2014to Jun 2014
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

Has had a self-reported oculo-visual examination in the last two years.
Is at least 18 years of age and has full legal capacity to volunteer.
Has read and understood the information consent letter.
Is willing and able to follow instructions and maintain the appointment schedule.
Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
Currently wears soft contact lenses.
Has clear corneas and no active ocular disease.
Has not worn lenses for at least 12 hours before the examination

Who cannot join

Has never worn contact lenses before.
Has any systemic disease affecting ocular health.
Is using any systemic or topical medications that will affect ocular health.
Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.

Show all 9Show fewer

Is aphakic.
Has undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.

Trial locations and contacts

1 site in 1 country.

United States1 site

CORL, Indiana University
Bloomington, Indiana, 47405

Other trials in United States

About this study

Read the detailed description

Evaluate the clinical performance of Biofinity toric MTO lenses against current commercial Biofinity toric lenses over 6 hours of lens wear.

Conditions: Myopia, Astigmatism
Being tested: comfilcon A MTO, comfilcon A
Medical subject headings: Myopia, Astigmatism

What participants receive

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

comfilcon A MTODevice
Also called Biofinity Toric MTO
Randomized to a test lens in one eye and control lens in the other as a matched pair.
comfilcon ADevice
Also called Biofinity Toric
Randomized to a test lens in one eye and control lens in the other as a matched pair.

Study groups in NCT02185105
Study group	Role	What they receive
comfilcon A MTO	Experimental	Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. Receives: Device: comfilcon A
comfilcon A	Active comparator	Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule. Receives: Device: comfilcon A MTO

What is being measured

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

Lens Surface Assessment of Study Lenses - Surface Wettability
Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)
Measured: 15min & 6hrs
Lens Surface Assessment of Study Lenses - Deposits
Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film > 75% of surface)
Measured: 15min & 6hrs
Lens Surface Assessment of Study Lenses - Surface Acceptance
Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)
Measured: 15min & 6hrs
Subjective Rating For Comfort - Comfort Since Last Visit
Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever)
Measured: 15min, 3hrs, 6hrs
Subjective Rating For Comfort Preference
Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)
Measured: 1min, 15min, 3hrs, 6hrs
Subjective Rating For Handling - Insertion
Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye)
Measured: 1 min
Subjective Rating For Handling - Removal
Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye)
Measured: 1 min
Investigator's Assessment of Stability
Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability.
Measured: 15min & 6hrs
General Lens Fit - Fit Acceptance
Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)
Measured: 15min & 6hrs
Lens Fitting - Rotation/Mislocation
Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-).
Measured: Baseline, 15min & 6hrs
Anterior Ocular Health - Corneal Staining (Central)
Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
Measured: baseline & 6hrs
Anterior Ocular Health - Corneal Staining (Nasal)
Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
Measured: baseline & 6hrs
Anterior Ocular Health - Corneal Staining (Temporal)
Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
Measured: baseline & 6hrs
Anterior Ocular Health - CornealStaining (Superior)
Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
Measured: baseline & 6hrs
Anterior Ocular Health - Corneal Staining (Inferior)
Corneal staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
Measured: baseline & 6hrs
Anterior Ocular Health - Conjunctival Staining (Nasal)
Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Measured: baseline & 6hrs
Anterior Ocular Health - Conjunctival Staining (Superior)
Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Measured: baseline & 6hrs
Anterior Ocular Health - Conjunctival Staining (Temporal)
Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Measured: baseline & 6hrs
Anterior Ocular Health - Conjunctival Staining (Inferior)
Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Measured: baseline & 6hrs

Timeline

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

Jun 2014Jun 2014

First posted9 Jul 2014 (estimated)
Study startJun 2014
Primary completionJun 2014
Study completionJun 2014

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: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02185105
Sponsor's protocol ID: CV-14-04
Status last verified: Jan 2017
First submitted: 7 Jul 2014
Last updated: 7 Mar 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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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 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses
ClinicalTrials.gov ID: NCT02185105
Acronym / sponsor ID: CV-14-04
Conditions: Myopia, Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 9 Jul 2014 (estimated)
Results: Posted 2 Jan 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

Evaluate the clinical performance of Biofinity toric MTO lenses against current commercial Biofinity toric lenses over 6 hours of lens wear.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
comfilcon A MTO	Experimental	Device: comfilcon ASubjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.
comfilcon A	Active comparator	Device: comfilcon A MTOSubjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Has had a self-reported oculo-visual examination in the last two years.
Is at least 18 years of age and has full legal capacity to volunteer.
Has read and understood the information consent letter.
Is willing and able to follow instructions and maintain the appointment schedule.
Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.

Key exclusion criteria (9 listed)

Has never worn contact lenses before.
Has any systemic disease affecting ocular health.
Is using any systemic or topical medications that will affect ocular health.
Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.

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 MTOAlso: Biofinity Toric MTORandomized to a test lens in one eye and control lens in the other as a matched pair.	Device	comfilcon A
comfilcon AAlso: Biofinity ToricRandomized to a test lens in one eye and control lens in the other as a matched pair.	Device	comfilcon A MTO

Primary outcome

Lens Surface Assessment of Study Lenses - Surface Wettability
Time frame: 15min & 6hrs
Investigator's objective assessment of lens surface wettability at 15min and 6hrs. Scale (0-4; 0=non-wetting, 4=Excellent)
Lens Surface Assessment of Study Lenses - Deposits
Time frame: 15min & 6hrs
Investigator's objective assessment of lens surface deposition at 15min and 6hrs. Graded on the appearance of lens surface by slit lamp. Rated on a scale (0-4; 0=no deposits, 4=deposits ≥0.5mm or film > 75% of surface)
Lens Surface Assessment of Study Lenses - Surface Acceptance
Time frame: 15min & 6hrs
Investigator's objective assessment of surface acceptance at 15min and 6hrs. Rated on a scale (0-4; 0=very poor, 4=excellent)
Subjective Rating For Comfort - Comfort Since Last Visit
Time frame: 15min, 3hrs, 6hrs
Participant's subjective rating of comfort now of study lenses. Surveyed at 15min, 3hr, and 6hr. Scale (0-100; 0=cannot be worn, causes pain, 100=cannot be felt ever)
Subjective Rating For Comfort Preference
Time frame: 1min, 15min, 3hrs, 6hrs
Participant's subjective rating of comfort preference of study lenses. Scale: (Strongly Prefer Right lens - Strongly Prefer Left Lens)
Subjective Rating For Handling - Insertion
Time frame: 1 min
Participant's subjective rating for ease of insertion of the study lenses. Scale (0-100; 0=could not place lens on eye;100=always easy to place lens on eye)
Subjective Rating For Handling - Removal
Time frame: 1 min
Participant's subjective rating for ease of removal of study lenses. Scale (0-100; 0=could not remove lens from eye;100=always easy to place remove from eye)
Investigator's Assessment of Stability
Time frame: 15min & 6hrs
Investigator's assessment of the study lenses overall stability difference measured from 0-180 degrees, 0=very good stability, 180=very bad stability.
General Lens Fit - Fit Acceptance
Time frame: 15min & 6hrs
Investigator's assessment for fit acceptance of study lenses. Scale: 0-4 (0=Should not be worn; 4=Perfect)
Lens Fitting - Rotation/Mislocation
Time frame: Baseline, 15min & 6hrs
Investigator's observed the rotation/mislocation (toric mark) of study lenses from the desired 6 o'clock position following temp rotation 30 degrees, 10 blinks; rotation toward desired 6 o'clock position=(+); rotation away from desired 6 o'clock position=(-).
Anterior Ocular Health - Corneal Staining (Central)
Time frame: baseline & 6hrs
Corneal staining (central) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
Anterior Ocular Health - Corneal Staining (Nasal)
Time frame: baseline & 6hrs
Corneal staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
Anterior Ocular Health - Corneal Staining (Temporal)
Time frame: baseline & 6hrs
Corneal staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
Anterior Ocular Health - CornealStaining (Superior)
Time frame: baseline & 6hrs
Corneal staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
Anterior Ocular Health - Corneal Staining (Inferior)
Time frame: baseline & 6hrs
Corneal staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. (Scale 0-4, 0=No staining; 4= >45% of area)
Anterior Ocular Health - Conjunctival Staining (Nasal)
Time frame: baseline & 6hrs
Conjunctival staining (nasal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Anterior Ocular Health - Conjunctival Staining (Superior)
Time frame: baseline & 6hrs
Conjunctival staining (superior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Anterior Ocular Health - Conjunctival Staining (Temporal)
Time frame: baseline & 6hrs
Conjunctival staining (temporal) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).
Anterior Ocular Health - Conjunctival Staining (Inferior)
Time frame: baseline & 6hrs
Conjunctival staining (inferior) for comfilcon (A) toric and comfilcon (A) toric XR lenses assessed at baseline and 6 hours. Scale: 0-4, (0=None; 4=Deep confluent).

Results and safety

Results posted to the registry on 2 Jan 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 XR Toric (Extended Range) / Comfilcon A Toric	30	30

Primary outcome: Lens Surface Assessment of Study Lenses - Surface Wettability

Time frame: 15min & 6hrs. Mean (Standard Deviation). Unit: units on a scale

Measure	Comfilcon A XR (Extended Range) Toric n = 30	Comfilcon A Toric n = 30
15 minutes	3.4 (0.3)	3.4 (0.2)
6 hours	3.4 (0.4)	3.4 (0.4)

Primary outcome: Lens Surface Assessment of Study Lenses - Deposits

Time frame: 15min & 6hrs. Mean (Standard Deviation). Unit: units on a scale

Measure	Comfilcon A XR Toric (Extended Range) n = 30	Comfilcon A Toric n = 30
15 minutes	0.00 (0.00)	0.00 (0.00)
6 hours	0.03 (0.18)	0.00 (0.00)

Primary outcome: Lens Surface Assessment of Study Lenses - Surface Acceptance

Time frame: 15min & 6hrs. Mean (Standard Deviation). Unit: units on a scale

Measure	Comfilcon A XR Toric (Extended Range) n = 30	Comfilcon A Toric n = 30
15 minutes	3.4 (0.4)	3.4 (0.4)
6 hours	3.4 (0.5)	3.4 (0.5)

Primary outcome: Subjective Rating For Comfort - Comfort Since Last Visit

Time frame: 15min, 3hrs, 6hrs. Mean (Standard Deviation). Unit: units on a scale

Measure	Comfilcon A XR Toric (Extended Range) n = 30	Comfilcon A Toric n = 30
15 minutes	88 (11)	90 (10)
3 hours	84 (17)	87 (12)
6 hours	84 (15)	88 (11)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Comfilcon A MTO	0 of 30 (0%)	0 of 30 (0%)	Not reported
Comfilcon A	0 of 30 (0%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
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.

Pete S Kollbaum, O.D. principal investigator

Indiana University

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

Questions about this trial

What is this clinical trial studying?

A study testing comfilcon A MTO and comfilcon A in people with Myopia and Astigmatism, run by CooperVision, Inc. at 1 site 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 8 inclusion and 9 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 7 Mar 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 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 2 Jan 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 Surface Assessment of Study Lenses - Surface Wettability (time frame: 15min & 6hrs). The study lists 19 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 NCT02185105.

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 7 Mar 2017.