MyopiaNCT02193178

Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges

A study testing comfilcon A Toric in people with Myopia and Astigmatism, run by CooperVision, Inc. at 2 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 study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses. 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 Toric
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 2 sitesUnited States
Study dates: Jul 2014to Apr 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has had an 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 20/50 or better (in at least one eye)
Currently wears soft toric contact lenses in both eyes

Show all 14Show fewer

Subject contact lens prescription must fall under one of the contact lens power ranges for at least one eye:
-20.00D to -10.50D spherical powers and cylinder powers from - 0.75 to -2.25
+8.50D to +20.00D spherical powers and cylinder powers from - 0.75 to -2.25
-20.00D to -6.50D spherical powers and cylinder powers from -2.75 to -5.75
-6.00D to +6.00D spherical powers and cylinder powers from -2.75 to -5.75
+6.50D to +20.00D spherical powers and cylinder powers from-2.75 to -5.75
Has clear corneas and no active ocular disease
Demonstrates an acceptable fit with the study lenses

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 abnormality that would affect the wearing of contact lenses;
Has undergone corneal refractive surgery;
Is participating in any other type of eye related clinical or research study.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Bloomington, Indiana, 47405
Texas Eye Research and Technology Center (TERTC) College of Optometry, University of Houston
Houston, Texas, 77204

Other trials in United States

About this study

The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses.

Read the detailed description

The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses. Further, that a minimum of 80% of those enrolled will complete 2 weeks of lens wear with no contraindication to continue.

Conditions: Myopia, Astigmatism
Being tested: comfilcon A Toric
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 ToricDevice
Also called Biofinity
Contact lenses

Study groups in NCT02193178
Study group	Role	What they receive
comfilcon A toric	Experimental	Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses. Receives: Device: comfilcon A Toric

What is being measured

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

Overall Comfort
Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever.
Measured: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Overall Vision
Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time.
Measured: 2 weeks prior to baseline, Baseline, 2 weeks post
Handling
Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy
Measured: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Overall Satisfaction
Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied.
Measured: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Lens Fit - Rotation
Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation.
Measured: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Lens Fit - Overall Stability
Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability
Measured: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Lens Fit Acceptance
General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum)
Measured: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Anterior Ocular Health - Palpebral Hyperemia and Roughness
Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe
Measured: Baseline and 2 weeks
Anterior Ocular Health - Bulbar and Limbal Redness
Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection
Measured: Baseline and 2 weeks
Anterior Ocular Health - Corneal Staining
Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= >45% of area
Measured: Baseline and 2 weeks
Anterior Ocular Health - Conjunctival Staining and Indentation
Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe
Measured: Baseline and 2 weeks
Visual Acuity
Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR.
Measured: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Subjective Preference - Comfort
Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
Measured: Baseline and 2 weeks
Preference - Vision
Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
Measured: Baseline and 2 weeks
Preference - Handling
Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
Measured: Baseline and 2 weeks
Overall Preference
Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
Measured: Baseline and 2 weeks
Investigator Acceptability
Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree.
Measured: Baseline and 2 weeks

Timeline

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

Jul 2014Apr 2016

First posted17 Jul 2014 (estimated)
Study startJul 2014
Primary completionApr 2016
Study completionApr 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02193178
Sponsor's protocol ID: CV-14-05
Status last verified: Jul 2020
First submitted: 15 Jul 2014
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: Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges
ClinicalTrials.gov ID: NCT02193178
Acronym / sponsor ID: CV-14-05
Conditions: Myopia, Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 17 Jul 2014 (estimated)
Results: Posted 17 Feb 2017

Clinical summary

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

The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
comfilcon A toric	Experimental	Device: comfilcon A ToricParticipants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.

Who may qualify

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

Key inclusion criteria (14 listed)

Has had an 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 20/50 or better (in at least one eye)

Key exclusion criteria (6 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 abnormality that would affect the wearing of contact lenses;
Has undergone corneal refractive surgery;

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 ToricAlso: BiofinityContact lenses	Device	comfilcon A toric

Primary outcome

Overall Comfort
Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Subjective ratings for overall comfort for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A lenses assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=cannot be worn, causes pain, and 100=cannot be felt ever.
Overall Vision
Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post
Subjective ratings for overall vision for habitual lenses assessed 2 weeks prior to baseline and vision for comfilcon A assessed at baseline and 2 weeks post.Scale 0-100, 0=Extremely poor vision all of the time, cannot function, 100=Excellent vision all of the time.
Handling
Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Subjective ratings for handling for habitual lenses assessed 2 weeks prior to baseline and handling for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Very difficult, 100=Very easy
Overall Satisfaction
Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Subjective ratings for overall satisfaction for habitual lenses assessed 2 weeks prior to baseline and overall satisfaction for comfilcon A assessed at baseline and 2 weeks post baseline. Scale 0-100, 0=Extremely dissatisfied, 100=Extremely satisfied.
Lens Fit - Rotation
Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Lens Fit (rotation) for habitual lenses were assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A, lens fit rotation was assessed at baseline and 2 weeks. Lens rotation was measured within 10 degrees of the desired 6 o'clock position. Scale 0-180 degrees, 0=no rotation, 180=max rotation.
Lens Fit - Overall Stability
Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Lens Fit (stability) for habitual lenses assessed 2 weeks prior to baseline and then refitted with comfilcon A lenses. After refitting with comfilcon A lenses, stability was assessed at baseline and 2 weeks. Scale 0-4, 0=Totally unstable, can't be worn to provide acceptable vision correction for an astigmatism, 4=Excellent orientation and optimum rotational recovery and stability
Lens Fit Acceptance
Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
General lens fit acceptance for habitual lenses assessed 2 weeks prior to baseline and refitted with comfilcon A lenses, which were assessed at baseline and at 2 weeks. (Scale 0-4, 0=Can't be worn; 4=Optimum)
Anterior Ocular Health - Palpebral Hyperemia and Roughness
Time frame: Baseline and 2 weeks
Palpebral hyperemia and roughness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None, 4=Severe
Anterior Ocular Health - Bulbar and Limbal Redness
Time frame: Baseline and 2 weeks
Bulbar and limbal redness for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=None; 4=Severe injection
Anterior Ocular Health - Corneal Staining
Time frame: Baseline and 2 weeks
Corneal staining for comfilcon A lenses assessed at baseline and 2 weeks. Scale 0-4, 0=No staining; 4= >45% of area
Anterior Ocular Health - Conjunctival Staining and Indentation
Time frame: Baseline and 2 weeks
Conjunctival staining and indentation for comfilcon A lenses assessed at baseline and 2 weeks. Conjuctival staining scale 0-4, 0=None, 4=Severe
Visual Acuity
Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline
Visual acuity for habitual lenses assessed 2 weeks prior to baseline and for comfilcon A assessed at baseline and 2 weeks post baseline using logMAR.
Subjective Preference - Comfort
Time frame: Baseline and 2 weeks
Subjective preference for comfort between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
Preference - Vision
Time frame: Baseline and 2 weeks
Subjective preference for vision between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
Preference - Handling
Time frame: Baseline and 2 weeks
Subjective preference for handling between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
Overall Preference
Time frame: Baseline and 2 weeks
Overall subjective preference between habitual lenses and comfilcon A lenses assessed at baseline and 2 weeks. Preference choices: Prefers comfilcon A lenses, No preference, Prefers habitual lenses
Investigator Acceptability
Time frame: Baseline and 2 weeks
Investigator's preference on acceptability of refitting subjects in to comfilcon A lens based on lens performance assessed at baseline and 2 weeks.Scale 1-5, 1=Strongly agree, 5=Strongly disagree.

Results and safety

Results posted to the registry on 17 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
Overall Participants	15	13

Primary outcome: Overall Comfort

Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Habitual Lenses n = 14	Comfilcon A - Baseline n = 14	Comfilcon A - 2 Weeks n = 13
Value	80 (16)	91 (9)	88 (11)

Population analysed: One participant discontinued and therefore data was not included in analysis.

Primary outcome: Overall Vision

Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post. Mean (Standard Deviation). Unit: units on a scale

Measure	Habitual Lenses n = 14	Comfilcon A - Baseline n = 14	Comfilcon A - 2 Weeks n = 13
Value	75 (17)	85 (15)	80 (18)

Population analysed: One participant discontinued and therefore data was not included in analysis.

Primary outcome: Handling

Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Habitual Lenses n = 14	Comfilcon A - Baseline n = 14	Comfilcon A - 2 Weeks n = 13
Value	88 (25)	89 (16)	94 (9)

Population analysed: One participant discontinued and therefore data was not included in analysis.

Primary outcome: Overall Satisfaction

Time frame: 2 weeks prior to baseline, Baseline, 2 weeks post baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Habitual Lenses n = 14	Comfilcon A - Baseline n = 14	Comfilcon A - 2 Weeks n = 13
Value	90 (10)	92 (9)	89 (10)

Population analysed: One participant discontinued and therefore data was not included in analysis.

Adverse events

Time frame: From dispense up to two weeks for each study lenses. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Comfilcon A Toric XR MTO	0 of 15 (0%)	0 of 15 (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.

Related trials for Myopia

Recruiting
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Clinical Performance and Outcomes After Toric Lens Transition
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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.

Jan Bergmanson, OD PhD principal investigator

Texas Eye Research and Technology Center (TERTC), School of Optometry, University of Houston

Pete Kollbaum, OD PhD principal investigator

Clinical Optics Research Lab (CORL), Indiana University School of Optometry, Indiana University

2 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 Toric in people with Myopia and Astigmatism, run by CooperVision, Inc. at 2 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 6 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 2 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 17 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?

Overall Comfort (time frame: 2 weeks prior to baseline, Baseline, 2 weeks post 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 NCT02193178.

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.