MyopiaNCT04050618

Evaluation Of One Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear

A study testing fanfilcon A test lens in people with Myopia, run by CooperVision, Inc. at 6 sites in United States.

Completed

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

Trial summary

To evaluate the comparative clinical performance of the fanfilcon A silicone hydrogel lens used in daily wear and to compare this with competitive hydrogel lens products. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia
What is being tested?: fanfilcon A test lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 114 participants
Where: 6 sitesUnited States
Study dates: 9 Jun 2019to 8 Nov 2019
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

Be a currently adapted soft contact lens wearer (>1 month of lens wear).
Be at least 18 years of age.
Refractive astigmatism <1.00D in both eyes.
Have clear corneas and be free of any anterior segment disorders.
Be correctable through spherocylindrical refraction to 20/25 or better in each eye.
Contact lens sphere requirement between -1.00D and -6.00D (inclusive).

Show all 16Show fewer

Require visual correction in both eyes (monovision allowed, no monofit).
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
No amblyopia
No strabismus
No evidence of lid abnormality or infection
No conjunctival abnormality or infection that would contraindicate contact lens wear
No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
No other active ocular disease.
Own a mobile phone and be able to respond to SMS survey during the period 8am-8pm.
Willing to comply with the wear and study visit schedule.

Who cannot join

Using CooperVision Avaira Vitality, J\&J Acuvue 2 or CooperVision Biomedics 55.
Require toric or multifocal contact lenses.
Previously shown a sensitivity to any of the study solution components.
Any systemic or ocular disease or allergies affecting ocular health.
Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance.
Clinically significant (>Grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.

Show all 16Show fewer

Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea.
Keratoconus or other corneal irregularity.
Aphakia or amblyopia.
Have undergone corneal refractive surgery or any anterior segment surgery.
Abnormal lacrimal secretions.
Has diabetes.
Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
History of chronic eye disease (e.g. glaucoma).
Pregnant or lactating or planning a pregnancy at the time of enrolment.
Participation in any concurrent clinical trial or in last 30 days.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Omega Vision Center PA (DBA Sabal Eye Care)
Longwood, Florida, 32779
Office of William J. Bogus, O.D.
Salt Lake City, Utah, 84106
Golden Vision
Sarasota, Florida, 34232
Frazier Vision, Inc
Tyler, Texas, 75703
Sacco Eye Group
Vestal, New York, 13850
Golden Optometric Group
Whittier, California, 90606

Other trials in United States

About this study

Official title: Multi-Center Cross-Over Evaluation Of Avaira Vitality Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear

To evaluate the comparative clinical performance of the fanfilcon A silicone hydrogel lens used in daily wear and to compare this with competitive hydrogel lens products.

Read the detailed description

This 8-week, subject-masked, bilateral, two-part, cross-over evaluation will compare the clinical performance of fanfilcon A silicone hydrogel contact lens and competitive hydrogel contact lenses when worn daily. Lenses will be replaced either on a 2-weekly or 4-weekly basis, depending on control lens group.

Conditions: Myopia
Being tested: fanfilcon A test lens, ocufilcon D control lens, etafilcon A control lens
Medical subject headings: Myopia

What participants receive

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

fanfilcon A test lensDevice
Also called test lens, Avaira Vitality
Silicone hydrogel contact lens
ocufilcon D control lensDevice
Also called Biomedics 55 Premier, ocufilcon D (4-weekly) control lens
hydrogel contact lens
etafilcon A control lensDevice
Also called etafilcon A (2-weekly) control lens, Acuvue 2
hydrogel contact lens

Study groups in NCT04050618
Study group	Role	What they receive
ocufilcon D control lens, then fanfilcon A test lens	Experimental	Participants will wear the ocufilcon D control lens for 4 weeks, then crossover to fanfilcon A test lens for 4 weeks of daily wear. Receives: Device: fanfilcon A test lens; Device: ocufilcon D control lens
etafilcon A controls, then fanfilcon A test lens	Experimental	Participants will wear the etafilcon D control lens for 2 weeks, then crossover to fanfilcon A test lens for 2 weeks of daily wear. Receives: Device: fanfilcon A test lens; Device: etafilcon A control lens

What is being measured

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

Subjective Overall Comfort Rating
Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses
Measured: Two weeks
Subjective Overall Comfort Rating
Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses
Measured: Four weeks

Secondary outcomes (45)

Average Wearing Time
Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes
Measured: Two weeks
Average Wearing Time
Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes
Measured: Four weeks
Average Comfortable Wearing Time
Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.
Measured: Two weeks
Average Comfortable Wearing Time
Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.
Measured: Four weeks
Lens Centration
Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)).
Measured: Baseline (after 15 minutes)
Lens Centration
Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)).
Measured: Two weeks
Lens Centration
Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)).
Measured: Four weeks
Corneal Coverage
Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)
Measured: Baseline (after 15 minutes of lens dispense)
Corneal Coverage
Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)
Measured: Two weeks
Corneal Coverage
Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)
Measured: Four weeks
Post-Blink Movement
Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)
Measured: Baseline (after 15 minutes of lens dispense)
Post-Blink Movement
Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)
Measured: Two weeks
Post-Blink Movement
Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)
Measured: Four weeks
Lens Tightness - Push-up Test
Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)
Measured: Baseline (after 15 minutes of lens dispense)
Lens Tightness - Push-up Test
Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)
Measured: Two weeks
Lens Tightness - Push-up Test
Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)
Measured: Four weeks
Overall Lens Fit Acceptance
Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)
Measured: Baseline (after 15 minutes of lens dispense)
Overall Lens Fit Acceptance
Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)
Measured: Two weeks
Overall Lens Fit Acceptance
Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)
Measured: Four weeks
Rating of Lens Surface Wettability
Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).
Measured: Baseline (after 15 minutes of lens dispense)
Rating of Lens Surface Wettability
Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).
Measured: Two weeks
Rating of Lens Surface Wettability
Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).
Measured: Four weeks
Presence of Film Deposits
Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye).
Measured: Two weeks
Presence of Film Deposits
Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye).
Measured: Four weeks
Number of White Spot Deposits
Number of white spot deposits assessed using slit lamp with white light, low medium magnification
Measured: Two weeks
Number of White Spot Deposits
Number of white spot deposits assessed using slit lamp with white light, low medium magnification
Measured: Four weeks
Primary Gaze Lag
Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)
Measured: Baseline (after 15 minutes of lens dispense)
Primary Gaze Lag
Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)
Measured: Two weeks
Primary Gaze Lag
Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)
Measured: Four weeks
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Measured: Day 3 - 8:00am
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Measured: Day 3 - 12:00pm
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Measured: Day 3 - 4:00pm
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Measured: Day 3 - 8:00pm
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Measured: Day 7 - 8:00am
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Measured: Day 7 - 12:00pm
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Measured: Day 7 - 4:00pm
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Measured: Day 7 - 8:00pm
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Measured: Day 12 - 8:00am
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Measured: Day 12 - 12:00pm
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Measured: Day 12 - 4:00pm
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Measured: Day 12 - 8:00pm
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Measured: Day 26 - 8:00am
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Measured: Day 26 - 12:00pm
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Measured: Day 26 - 4:00pm
Comfort Throughout the Day
Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses
Measured: Day 26 - 8:00pm

Timeline

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

9 Jun 20198 Nov 2019

First posted8 Aug 2019
Study start9 Jun 2019
Primary completion24 Sep 2019
Study completion8 Nov 2019

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: Non-randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04050618
Sponsor's protocol ID: EX-MKTG-103
Status last verified: Sep 2020
First submitted: 7 Aug 2019
Last updated: 19 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-Center Cross-Over Evaluation Of Avaira Vitality Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear
ClinicalTrials.gov ID: NCT04050618
Acronym / sponsor ID: EX-MKTG-103
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 9 Jun 2019 (actual)
Primary completion: 24 Sep 2019 (actual)
Study completion: 8 Nov 2019 (actual)
First posted: 8 Aug 2019 (actual)
Results: Posted 19 Oct 2020

Clinical summary

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

To evaluate the comparative clinical performance of the fanfilcon A silicone hydrogel lens used in daily wear and to compare this with competitive hydrogel lens products.

Detailed description

Study design

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

Arm	Type	Receives
ocufilcon D control lens, then fanfilcon A test lens	Experimental	Device: fanfilcon A test lens, Device: ocufilcon D control lensParticipants will wear the ocufilcon D control lens for 4 weeks, then crossover to fanfilcon A test lens for 4 weeks of daily wear.
etafilcon A controls, then fanfilcon A test lens	Experimental	Device: fanfilcon A test lens, Device: etafilcon A control lensParticipants will wear the etafilcon D control lens for 2 weeks, then crossover to fanfilcon A test lens for 2 weeks of daily wear.

Who may qualify

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

Key inclusion criteria (16 listed)

Be a currently adapted soft contact lens wearer (>1 month of lens wear).
Be at least 18 years of age.
Refractive astigmatism <1.00D in both eyes.
Have clear corneas and be free of any anterior segment disorders.
Be correctable through spherocylindrical refraction to 20/25 or better in each eye.

Key exclusion criteria (16 listed)

Using CooperVision Avaira Vitality, J\&J Acuvue 2 or CooperVision Biomedics 55.
Require toric or multifocal contact lenses.
Previously shown a sensitivity to any of the study solution components.
Any systemic or ocular disease or allergies affecting ocular health.
Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance.

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
fanfilcon A test lensAlso: test lens, Avaira VitalitySilicone hydrogel contact lens	Device	etafilcon A controls, then fanfilcon A test lens, ocufilcon D control lens, then fanfilcon A test lens
ocufilcon D control lensAlso: Biomedics 55 Premier, ocufilcon D (4-weekly) control lenshydrogel contact lens	Device	ocufilcon D control lens, then fanfilcon A test lens
etafilcon A control lensAlso: etafilcon A (2-weekly) control lens, Acuvue 2hydrogel contact lens	Device	etafilcon A controls, then fanfilcon A test lens

Primary outcome

Subjective Overall Comfort Rating
Time frame: Two weeks
Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses
Subjective Overall Comfort Rating
Time frame: Four weeks
Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses

45 secondary outcomes

Average Wearing Time
Time frame: Two weeks
Average Wearing Time
Time frame: Four weeks
Average Comfortable Wearing Time
Time frame: Two weeks
Average Comfortable Wearing Time
Time frame: Four weeks
Lens Centration
Time frame: Baseline (after 15 minutes)
Lens Centration
Time frame: Two weeks
Lens Centration
Time frame: Four weeks
Corneal Coverage
Time frame: Baseline (after 15 minutes of lens dispense)
Corneal Coverage
Time frame: Two weeks
Corneal Coverage
Time frame: Four weeks
Post-Blink Movement
Time frame: Baseline (after 15 minutes of lens dispense)
Post-Blink Movement
Time frame: Two weeks
Post-Blink Movement
Time frame: Four weeks
Lens Tightness - Push-up Test
Time frame: Baseline (after 15 minutes of lens dispense)
Lens Tightness - Push-up Test
Time frame: Two weeks
Lens Tightness - Push-up Test
Time frame: Four weeks
Overall Lens Fit Acceptance
Time frame: Baseline (after 15 minutes of lens dispense)
Overall Lens Fit Acceptance
Time frame: Two weeks
Overall Lens Fit Acceptance
Time frame: Four weeks
Rating of Lens Surface Wettability
Time frame: Baseline (after 15 minutes of lens dispense)
Rating of Lens Surface Wettability
Time frame: Two weeks
Rating of Lens Surface Wettability
Time frame: Four weeks
Presence of Film Deposits
Time frame: Two weeks
Presence of Film Deposits
Time frame: Four weeks
Number of White Spot Deposits
Time frame: Two weeks
Number of White Spot Deposits
Time frame: Four weeks
Primary Gaze Lag
Time frame: Baseline (after 15 minutes of lens dispense)
Primary Gaze Lag
Time frame: Two weeks
Primary Gaze Lag
Time frame: Four weeks
Comfort Throughout the Day
Time frame: Day 3 - 8:00am
Comfort Throughout the Day
Time frame: Day 3 - 12:00pm
Comfort Throughout the Day
Time frame: Day 3 - 4:00pm
Comfort Throughout the Day
Time frame: Day 3 - 8:00pm
Comfort Throughout the Day
Time frame: Day 7 - 8:00am
Comfort Throughout the Day
Time frame: Day 7 - 12:00pm
Comfort Throughout the Day
Time frame: Day 7 - 4:00pm
Comfort Throughout the Day
Time frame: Day 7 - 8:00pm
Comfort Throughout the Day
Time frame: Day 12 - 8:00am
Comfort Throughout the Day
Time frame: Day 12 - 12:00pm
Comfort Throughout the Day
Time frame: Day 12 - 4:00pm

Results and safety

Results posted to the registry on 19 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ocufilcon D Control Lens, Then Fanfilcon A Test Lens	58	56
Etafilcon A Controls, Then Fanfilcon A Test Lens	56	56

Primary outcome: Subjective Overall Comfort Rating

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

Measure	Ocufilcon D - Group A n = 57	Fanfilcon A - Group A n = 56	Etafilcon A - Group B n = 56	Fanfilcon A - Group B n = 56
Value	8.2 (2.04)	8.6 (1.19)	8.3 (1.72)	8.3 (1.64)

Primary outcome: Subjective Overall Comfort Rating

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

Measure	Ocufilcon D - Group A n = 56	Fanfilcon A - Group A n = 55
Value	7.9 (2.10)	8.6 (1.26)

45 secondary outcomes are reported in the full results.

Adverse events

Time frame: From dispense up to 4 weeks for ocufilcon D and fanfilcon A - Group A, from dispense up to 2 weeks for etafilcon A and fanfilcon A - Group B. A total of 8 weeks. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ocufilcon D - Group A	0 of 58 (0%)	2 of 58 (3.4%)	0 of 58
Fanfilcon A - Group A	0 of 57 (0%)	0 of 57 (0%)	0 of 57
Etafilcon A - Group B	0 of 56 (0%)	0 of 56 (0%)	0 of 56
Fanfilcon A - Group B	0 of 56 (0%)	0 of 56 (0%)	0 of 56

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

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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.

David C Ardaya, OD principal investigator

Golden Optometric Group

William J Bogus, OD principal investigator

Office of William J. Bogus, O.D.

Bryan E Frazier, OD principal investigator

Frazier Vision, Inc

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

Questions about this trial

What is this clinical trial studying?

A study testing fanfilcon A test lens in people with Myopia, run by CooperVision, Inc. at 6 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 16 inclusion and 16 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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 19 Oct 2020). 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?

Subjective Overall Comfort Rating (time frame: Two weeks). The study lists 2 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 NCT04050618.

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 19 Oct 2020.