MyopiaNCT02060539

Multicenter Dispensing Study of Biofinity Lenses in Extended Range

A study testing Biofinity XR in people with Myopia and Hyperopia, run by CooperVision, Inc. at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To obtain subjective and objective feedback on the clinical performance of Biofinity lenses after at least two weeks daily wear in existing contact lens wearers compared with their habitual lenses. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Myopia, Hyperopia
What is being tested?: Biofinity XR
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 4 sitesin 2 countries
Study dates: Oct 2013to Dec 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
Healthy volunteers accepted
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) with their habitual vision correction
Currently wears soft contact lenses

Show all 9Show fewer

They should require contact lens powers between -12.00 and -20.00D or between +8.00 and +15.00D
Has clear corneas and no active ocular disease
Demonstrates an acceptable fit with the study lenses.

Who cannot join

Has any systemic disease affecting ocular health
Is taking medication, such as antihistamine eye drops, oral and ophthalmic betaadrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
Have any active ocular disease and/or infection that would contraindicate contact lens wear.
Active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Has worn gas permeable contact lenses within the last month.
Is aphakic

Show all 9Show fewer

Has undergone corneal refractive surgery.
Is participating in any other type of clinical research study
Female who is currently pregnant or is breast-feeding.

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

United States3 sites

UC Berkeley Clinica Research Center
Berkeley, California, 94720-2020
TERTC, University of Houston
Houston, Texas, 77204-2020
CORL, Indiana University School of Optometry
Indianapolis, Indiana, 46266-6057

Other trials in United States

Canada1 site

CCLR, University of Waterloo
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

To obtain subjective and objective feedback on the clinical performance of Biofinity lenses after at least two weeks daily wear in existing contact lens wearers compared with their habitual lenses.

Conditions: Myopia, Hyperopia
Being tested: Biofinity XR
Medical subject headings: Myopia, Hyperopia

What participants receive

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

Biofinity XRDevice

Study groups in NCT02060539
Study group	Role	What they receive
Biofinity XR	Experimental	Participants dispensed Biofinity XR lenses over two weeks of lens wear Receives: Device: Biofinity XR

What is being measured

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

Dryness (During Day and Dryness at Night)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained habitual lens history at baseline.
Measured: Baseline
Dryness (During Day)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Measured: Dispense
Dryness (During Day and Dryness at Night)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at two weeks.
Measured: 2 Weeks
Comfort (Insertion, End of Day, Overall)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.
Measured: Baseline
Comfort (Insertion)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Measured: Dispense
Comfort (Insertion, End of Day, Overall)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.
Measured: 2 Weeks
Ghosting (Multiple Images)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame ghosting. Cannot be worn. 100=No ghosting ever.) Obtained habitual lens history at baseline.
Measured: Baseline
Ghosting (Multiple Images)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Measured: Dispense
Ghosting (Multiple Images)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at 2 weeks.
Measured: 2 Weeks
Hazing (Blurred Edges)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained habitual lens history at baseline.
Measured: Baseline
Hazing (Blurred Edges)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained at 2 weeks.
Measured: 2 Weeks
Vision Quality (During Day and at Night)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained habitual lens history at baseline.
Measured: Baseline
Vision Quality (During Day)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Measured: Dispense
Vision Quality (During Day and at Night)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at 2 weeks.
Measured: 2 Weeks
Handling (Insertion, Removal, Overall)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.
Measured: Baseline
Handling (Insertion, Removal, Overall)
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.
Measured: 2 weeks
Overall Satisfaction of Comfort, Vision, Handling
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Measured: Dispense
Overall Satisfaction of Comfort, Vision, Handling
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained habitual lens history at baseline.
Measured: Baseline
Overall Satisfaction of Comfort, Vision, Handling
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at baseline at 2 weeks.
Measured: 2 Weeks
Comfort Preference
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Measured: Dispense
Comfort Preference
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
Measured: 2 Weeks
Vision Preference
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Measured: Dispense
Vision Preference
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
Measured: 2 Weeks
Handling Preference
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
Measured: 2 Weeks
Overall Preference
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Measured: Dispense
Overall Preference
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
Measured: 2 Weeks

Secondary outcomes (16)

Lens Centration - Habitual Lenses
Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained for habitual lenses at baseline.
Measured: Baseline
Lens Centration
Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at baseline at dispense.
Measured: Dispense
Lens Centration
Objective measurement by investigator. (Assessed as optimum, slightly decentered, extremely decentered) Obtained at 2 weeks.
Measured: 2 Weeks
Lens Movement - Habitual Lenses
Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained for habitual lenses at baseline.
Measured: Baseline
Lens Movement
Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Measured: Dispense
Lens Movement
Objective measurement by investigator of overall post-blink lens movement. (Average Grade; Graded 0-4; 0=exceptionally tight, 2=optimal, 4=exceptionally loose) Obtained at 2 weeks wear.
Measured: 2 Weeks
Overall Fit Acceptance
Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained for habitual lenses at baseline.
Measured: Baseline
Overall Fit Acceptance
Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Measured: Dispense
Overall Fit Acceptance
Objective measurement by investigator of overall fit acceptance. (scale 0-4; 0=very poor, 4=very good) Obtained at 2 weeks.
Measured: 2 Weeks
Visual Acuity
Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained for habitual lenses at baseline.
Measured: Baseline
Visual Acuity
Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Measured: Dispense
Visual Acuity
Objective measurement by investigator of monocular high and low contrast logMar visual acuity. Visual Acuity High-Contrast (VA HC), Visual Acuity Low-Contrast (VA LC), Visual Acuity High-Contrast OU (VA HC OU), Visual Acuity Low-Contrast OU (VA LC OU). Obtained at 2 weeks.
Measured: 2 Weeks
Anterior Ocular Physiological Response
Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained for habitual lenses at baseline.
Measured: Baseline
Anterior Ocular Physiological Response
Ocular response assessed with the slit lamp using a Visual Analog Scale (0-4, 0=none, 4=severe). Obtained at 2 weeks.
Measured: 2 Weeks
Average Wearing Time
Participant response when asked, "Number of hours worn today?" (hours per day) Obtained for habitual lens at baseline.
Measured: Baseline
Average Wearing Time
Participant response when asked, "Number of hours worn today?" (hours per day) Obtained at 2 weeks.
Measured: 2 Weeks

Timeline

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

Oct 2013Dec 2014

First posted12 Feb 2014 (estimated)
Study startOct 2013
Primary completionApr 2014
Study completionDec 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02060539
Sponsor's protocol ID: CV-13-47
Status last verified: Jun 2015
First submitted: 6 Feb 2014
Last updated: 11 Dec 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

Not yet recruitingObservational study
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Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies
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RecruitingPhase 3
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Dispensing Study of Biofinity Lenses in Extended Range
ClinicalTrials.gov ID: NCT02060539
Acronym / sponsor ID: CV-13-47
Conditions: Myopia, Hyperopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Apr 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 12 Feb 2014 (estimated)
Results: Posted 30 Jun 2015

Clinical summary

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

To obtain subjective and objective feedback on the clinical performance of Biofinity lenses after at least two weeks daily wear in existing contact lens wearers compared with their habitual lenses.

Study design

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

Arm	Type	Receives
Biofinity XR	Experimental	Device: Biofinity XRParticipants dispensed Biofinity XR lenses over two weeks of lens wear

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 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) with their habitual vision correction

Key exclusion criteria (9 listed)

Has any systemic disease affecting ocular health
Is taking medication, such as antihistamine eye drops, oral and ophthalmic betaadrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
Have any active ocular disease and/or infection that would contraindicate contact lens wear.
Active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Has worn gas permeable contact lenses within the last month.

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
Biofinity XR	Device	Biofinity XR

Primary outcome

Dryness (During Day and Dryness at Night)
Time frame: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained habitual lens history at baseline.
Dryness (During Day)
Time frame: Dispense
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Dryness (During Day and Dryness at Night)
Time frame: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn, Extremely dry. 100=No dryness experienced at any time.) Obtained at two weeks.
Comfort (Insertion, End of Day, Overall)
Time frame: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.
Comfort (Insertion)
Time frame: Dispense
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Comfort (Insertion, End of Day, Overall)
Time frame: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.
Ghosting (Multiple Images)
Time frame: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame ghosting. Cannot be worn. 100=No ghosting ever.) Obtained habitual lens history at baseline.
Ghosting (Multiple Images)
Time frame: Dispense
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Ghosting (Multiple Images)
Time frame: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme ghosting. Cannot be worn. 100=No ghosting ever.) Obtained at 2 weeks.
Hazing (Blurred Edges)
Time frame: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreame haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained habitual lens history at baseline.
Hazing (Blurred Edges)
Time frame: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extreme haze. Cannot be worn. 100=No hazing experienced at any time.) Obtained at 2 weeks.
Vision Quality (During Day and at Night)
Time frame: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained habitual lens history at baseline.
Vision Quality (During Day)
Time frame: Dispense
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Vision Quality (During Day and at Night)
Time frame: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely poor vision all the time. Cannot function; 100=Excellent vision all of the time.) Obtained at 2 weeks.
Handling (Insertion, Removal, Overall)
Time frame: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained habitual lens history at baseline.
Handling (Insertion, Removal, Overall)
Time frame: 2 weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=cannot be worn,Causes pain; 100=Cannot be felt ever) Obtained at 2 weeks.
Overall Satisfaction of Comfort, Vision, Handling
Time frame: Dispense
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Overall Satisfaction of Comfort, Vision, Handling
Time frame: Baseline
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained habitual lens history at baseline.
Overall Satisfaction of Comfort, Vision, Handling
Time frame: 2 Weeks
Subjective response of participant by questionnaire on a visual analog scale (0-100, 0=Extremely dissatisfied; 100=Extremely satisfied.) Obtained at baseline at 2 weeks.
Comfort Preference
Time frame: Dispense
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Comfort Preference
Time frame: 2 Weeks
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
Vision Preference
Time frame: Dispense
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Vision Preference
Time frame: 2 Weeks
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
Handling Preference
Time frame: 2 Weeks
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.
Overall Preference
Time frame: Dispense
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at dispense; Lens pair one dispensed at the baseline visit and Lens pair two dispensed at 2 weeks visit.
Overall Preference
Time frame: 2 Weeks
Subjective response of participant by questionnaire on a likert scale (Prefer New Lenses Strongly, Prefer New Lenses Slightly, No Preference - both acceptable/both unacceptable, Prefer My Own Lenses Slightly, Prefer My Own Lenses Strongly) Obtained at 2 weeks.

16 secondary outcomes

Lens Centration - Habitual Lenses
Time frame: Baseline
Lens Centration
Time frame: Dispense
Lens Centration
Time frame: 2 Weeks
Lens Movement - Habitual Lenses
Time frame: Baseline
Lens Movement
Time frame: Dispense
Lens Movement
Time frame: 2 Weeks
Overall Fit Acceptance
Time frame: Baseline
Overall Fit Acceptance
Time frame: Dispense
Overall Fit Acceptance
Time frame: 2 Weeks
Visual Acuity
Time frame: Baseline
Visual Acuity
Time frame: Dispense
Visual Acuity
Time frame: 2 Weeks
Anterior Ocular Physiological Response
Time frame: Baseline
Anterior Ocular Physiological Response
Time frame: 2 Weeks
Average Wearing Time
Time frame: Baseline
Average Wearing Time
Time frame: 2 Weeks

Results and safety

Results posted to the registry on 30 Jun 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
Comfilcon A	19	19

Primary outcome: Dryness (During Day and Dryness at Night)

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

Measure	Comfilcon A n = 19
Dryness During Day	69 (17)
Dryness at End of Day	53 (25)

Primary outcome: Dryness (During Day)

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

Measure	Comfilcon A n = 19
Value	92 (10)

Primary outcome: Dryness (During Day and Dryness at Night)

Time frame: 2 Weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Comfilcon A n = 19
Dryness	87 (12)
Dryness at End of Day	76 (24)

Primary outcome: Comfort (Insertion, End of Day, Overall)

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

Measure	Comfilcon A n = 19
Comfort	86 (8)
Comfort at End of Day	62 (18)
Overall Comfort	83 (15)

16 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Comfilcon A	0 of 19 (0%)	0 of 19 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 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.

Lyndon Jones principal investigator

CCLR, University of Waterloo

Meng Lin principal investigator

CRC, University of California Berkeley

Jan Bergmanson principal investigator

TERTC, University of Houston

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Biofinity XR in people with Myopia and Hyperopia, run by CooperVision, Inc. at 4 sites in 2 countries.

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 9 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 11 Dec 2017. 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, Canada. 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 30 Jun 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?

Dryness (During Day and Dryness at Night) (time frame: Baseline). The study lists 26 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 NCT02060539.

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 11 Dec 2017.