MyopiaNCT03951610

A Dispensing Comparison of a Test Daily 1 Day Lens Against a Control 1 Day Lens.

A study testing Test lens in people with Myopia, 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.

Trial summary

The purpose of this study is to compare the dispensing performance of somofilcon A test 1 day contact lens against somofilcon A control 1 day contact lens. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia
What is being tested?: Test lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 2 sitesUnited States
Study dates: 21 Feb 2019to 4 Jun 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

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 (average wearing of 8 hours/day and 5 days/week) without the need of using rewetting drops

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Requires spectacle lens spherical powers between -1.00 to -5.75 diopters sphere (0.25D steps).
Has no more than 0.75 diopters of refractive astigmatism.
Has clear corneas and no active ocular disease.
Has not worn lenses for at least 12 hours before the examination.
Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit

Who cannot join

Is presently participating in any other clinical or research study including eye related clinical or research study.
Has never worn contact lenses before.
Has any systemic disease affecting ocular health.
Has any active ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
Has any known sensitivity to fluorescein dye or products to be used in the study.

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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.
Is aphakic.
Has undergone corneal refractive surgery.
Is pregnant, lactating, or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University Eye Center at Ketchum Health
Anaheim, California, 92807
Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
Bloomington, Indiana, 47405

Other trials in United States

About this study

Official title: A Dispensing Clinical Trial of Invigor 1 Daily Disposable Lens Against Clariti 1-day Lens

The purpose of this study is to compare the dispensing performance of somofilcon A test 1 day contact lens against somofilcon A control 1 day contact lens.

Read the detailed description

The purpose of this study is to evaluate the clinical performance of a silicone-hydrogel test contact lens compared to the commercially available silicone-hydrogel (control) contact lens when worn over one week for each lens type in a randomized, bilateral, cross-over, dispensing study on a daily disposable basis.

Conditions: Myopia
Being tested: Test lens, 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.

Test lensDevice
Also called Invigor I DD lens, Somofilcon A 1 day Test
contact lens
Control lensDevice
Also called Clariti 1-day, Somofilcon A 1 day control
contact lens

Study groups in NCT03951610
Study group	Role	What they receive
Test lens	Experimental	Subjects wearing the test lens for one week, either randomized as the first or second pair. Receives: Device: Test lens; Device: Control lens
Control lens	Active comparator	Subjects wearing the control lens for one week, either randomized as the first or second pair. Receives: Device: Test lens; Device: Control lens

What is being measured

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

Number of Participants With Lens Centration
Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I)
Measured: Baseline
Number of Participants With Lens Centration
Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I)
Measured: 1 week
Post Blink Movement
Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)
Measured: Baseline
Post Blink Movement
Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)
Measured: 1 week
Primary Gaze Lag
Primary Gaze Lag (measured in mm at 0.1mm steps)
Measured: baseline
Primary Gaze Lag
Primary Gaze Lag (measured in mm at 0.1mm steps)
Measured: 1 week
Up Gaze Lag
Up Gaze Lag (measured in mm at 0.1mm steps)
Measured: Baseline
Up Gaze Lag
Up Gaze Lag (measured in mm at 0.1mm steps)
Measured: 1 week
Push-Up Tightness
Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)
Measured: baseline
Push-Up Tightness
Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)
Measured: 1 week
Overall Fit Acceptance
Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum
Measured: Baseline
Overall Fit Acceptance
Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum
Measured: 1 week
Number of Participants With Overall Lens Fit Impression
Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable
Measured: Baseline
Number of Participants With Overall Lens Fit Impression
Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable
Measured: 1 week

Secondary outcomes (2)

Subjective Comfort Rating
Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)
Measured: Baseline
Subjective Comfort Rating
Subjective comfort scored 0-10 (0-10 scale, 0=uncomfortable, 10 = comfortable)
Measured: 1-week

Timeline

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

21 Feb 20194 Jun 2019

First posted15 May 2019
Study start21 Feb 2019
Primary completion5 Apr 2019
Study completion4 Jun 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: Randomised
Intervention model: Crossover
Model description: This will be a, prospective, double-masked, randomized, bilateral, 1 week cross-over, dispensing study
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03951610
Sponsor's protocol ID: CV-19-01
Status last verified: May 2020
First submitted: 11 Mar 2019
Last updated: 18 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Not yet recruiting
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Astigmatism
Active, not recruiting
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Recruiting
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dispensing Clinical Trial of Invigor 1 Daily Disposable Lens Against Clariti 1-day Lens
ClinicalTrials.gov ID: NCT03951610
Acronym / sponsor ID: CV-19-01
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 21 Feb 2019 (actual)
Primary completion: 5 Apr 2019 (actual)
Study completion: 4 Jun 2019 (actual)
First posted: 15 May 2019 (actual)
Results: Posted 18 Jun 2020

Clinical summary

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

The purpose of this study is to compare the dispensing performance of somofilcon A test 1 day contact lens against somofilcon A control 1 day contact lens.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: This will be a, prospective, double-masked, randomized, bilateral, 1 week cross-over, dispensing study

Arm	Type	Receives
Test lens	Experimental	Device: Test lens, Device: Control lensSubjects wearing the test lens for one week, either randomized as the first or second pair.
Control lens	Active comparator	Device: Test lens, Device: Control lensSubjects wearing the control lens for one week, either randomized as the first or second pair.

Who may qualify

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

Key inclusion criteria (11 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 (11 listed)

Is presently participating in any other clinical or research study including eye related clinical or research study.
Has never worn contact lenses before.
Has any systemic disease affecting ocular health.
Has any active ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.

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
Test lensAlso: Invigor I DD lens, Somofilcon A 1 day Testcontact lens	Device	Control lens, Test lens
Control lensAlso: Clariti 1-day, Somofilcon A 1 day controlcontact lens	Device	Control lens, Test lens

Primary outcome

Number of Participants With Lens Centration
Time frame: Baseline
Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I)
Number of Participants With Lens Centration
Time frame: 1 week
Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (>0.5mm N T S I)
Post Blink Movement
Time frame: Baseline
Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)
Post Blink Movement
Time frame: 1 week
Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)
Primary Gaze Lag
Time frame: baseline
Primary Gaze Lag (measured in mm at 0.1mm steps)
Primary Gaze Lag
Time frame: 1 week
Primary Gaze Lag (measured in mm at 0.1mm steps)
Up Gaze Lag
Time frame: Baseline
Up Gaze Lag (measured in mm at 0.1mm steps)
Up Gaze Lag
Time frame: 1 week
Up Gaze Lag (measured in mm at 0.1mm steps)
Push-Up Tightness
Time frame: baseline
Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)
Push-Up Tightness
Time frame: 1 week
Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)
Overall Fit Acceptance
Time frame: Baseline
Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum
Overall Fit Acceptance
Time frame: 1 week
Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum
Number of Participants With Overall Lens Fit Impression
Time frame: Baseline
Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable
Number of Participants With Overall Lens Fit Impression
Time frame: 1 week
Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable

2 secondary outcomes

Subjective Comfort Rating
Time frame: Baseline
Subjective Comfort Rating
Time frame: 1-week

Results and safety

Results posted to the registry on 18 Jun 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
Test Lens Then Control Lens	27	27
Control Lens Then Test Lens	25	25

Primary outcome: Number of Participants With Lens Centration

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Test Lens n = 52	Control Lens n = 52
Optimal	17	12
Slightly Decentered	34	39
Extreme Decentered	1	1

Primary outcome: Number of Participants With Lens Centration

Time frame: 1 week. Count of participants. Unit: Participants

Measure	Test Lens n = 52	Control Lens n = 52
Optimal	20	16
Slightly Decentered	31	36
Extreme Decentered	1	0

Primary outcome: Post Blink Movement

Time frame: Baseline. Mean (Standard Deviation). Unit: millimeters (mm)

Measure	Test Lens n = 52	Control Lens n = 52
Value	0.25 (0.10)	0.26 (0.09)

Primary outcome: Post Blink Movement

Time frame: 1 week. Mean (Standard Deviation). Unit: millimeters (mm)

Measure	Test Lens n = 52	Control Lens n = 52
Value	0.26 (0.12)	0.25 (0.12)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline up to 1 week for each intervention, a total of 2 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Lens	0 of 52 (0%)	0 of 52 (0%)	0 of 52
Control Lens	0 of 52 (0%)	0 of 52 (0%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing Test lens in people with Myopia, 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 11 inclusion and 11 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 18 Jun 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 18 Jun 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?

Number of Participants With Lens Centration (time frame: Baseline). The study lists 14 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 NCT03951610.

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 18 Jun 2020.