MyopiaNCT03496701

Performance of Wearers of Stenfilcon A Contact Lenses After A Refit With Test Lenses

A study testing Test lens in people with Myopia, run by CooperVision, Inc. at 4 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 aim of this study is to determine if habitual or adapted wearers of stenfilcon A control contact lenses can be refit into test lenses and be successful after one week of daily wear. Read more about this study

Who is it for?: Ages 18 to 35 years
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: 77 participants
Where: 4 sitesUnited States
Study dates: 18 Apr 2018to 17 Jan 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 to 35 years
All sexes
No healthy volunteers
Adult

Who may be able to join

A person is eligible for inclusion in the study if he/she:
Is between 18 and 35 years of age (inclusive)
Has read and signed the informed consent letter
Is willing and anticipated to follow instructions and maintain the appointment schedule
Habitually wears soft spherical contact lenses with a power between -1.00D to -6.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day.
Habitually wears or is able to be adequately refit into MyDay Sphere lenses

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Demonstrates an acceptable fit with the study lenses
Is correctable to a distance visual acuity of 0.20 logMAR (approximately 20/30) or better (in each eye) with the study contact lenses
Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week.
Manifest cylindrical spectacle refraction does not exceed -0.75DC in either eye
Has clear corneas and no active ocular disease
Has a contact lens refraction that fits within the available parameters of the study lenses.

Who cannot join

A person will be excluded from the study if he/she:
Is participating in any concurrent clinical research study
Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
Has a systemic condition that, in the opinion of the investigator, may affect the study measures
Is using any systemic or topical medications that in the opinion of the investigator may affect the study measures.
Presents with slit lamp findings or clinically significant anterior segment abnormalities that would contraindicate contact lens wear such as:

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Pathological dry eye or associated findings
Significant pterygium, pinguecula, or corneal scars within the visual axis
Neovascularization > 0.75 mm in from of the limbus
Giant papillary conjunctivitis (GCP) worse than grade 1
Anterior uveitis or iritis (or history in past year)
Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
History of corneal ulcers or fungal infections
Poor personal hygiene
Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study
Has aphakia, keratoconus or a highly irregular cornea.
Has presbyopia or has dependence on spectacles for near work over the contact lenses.
Has undergone refractive surgery.
Is pregnant, lactating or planning a pregnancy (by verbal communication) at the time of enrollment
Has participated in any other type of eye related clinical or research study within the last 7 days
Is habitually using rewetting/ lubricating eye drops (more than once per day)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Eric White, O.D., Inc.
San Diego, California, 92123
Golden Vision
Sarasota, Florida, 34232
Nittany Eye Associates
State College, Pennsylvania, 16801
Golden Optometric Group
Whittier, California, 90606

Other trials in United States

About this study

Official title: Performance of Wearers of MyDay Sphere Lenses After A Refit With MyDay Energys Lenses for One Week

The aim of this study is to determine if habitual or adapted wearers of stenfilcon A control contact lenses can be refit into test lenses and be successful after one week of daily wear.

Read the detailed description

This study is a prospective, multi-center, open label, bilateral, daily wear, one week dispensing study comparing performance of wearers of stenfilcon A control contact lenses after refit with test contact lenses.

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 stenfilcon A Test lens
contact lens
control lensDevice
Also called stenfilcon A Control lens
contact lens

Study groups in NCT03496701
Study group	Role	What they receive
Stenfilcon A / Test lens	Experimental	All subjects will first wear stenfilcon A contact lenses for one week, then refitted with test contact lenses to wear for one week. Receives: Device: Test lens; Device: control lens

What is being measured

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

Overall Lens Fit Acceptance
Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)
Measured: Baseline (After 10 minutes of lens dispense)
Overall Lens Fit Acceptance
Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)
Measured: 1 week on each study lenses

Secondary outcomes (4)

Lens Centration
Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)
Measured: Baseline - After 10 minutes of lens dispense
Lens Centration
Lens centration was assessed on a 3 point scale (1-Optimum, 2- Decentration acceptable, 3-Decentration unacceptable)
Measured: 1 week on each study lenses
Post-blink Movement
Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive)
Measured: Baseline (after 10 minutes of lens dispense)
Post-blink Movement
Post-blink movement assessed on a scale of 0-4, 1 step size (Scale: 0=Insufficient, 1=Minimal, 2=Optimal, 3=Moderate, 4=Excessive)
Measured: 1 week on each study lenses

Timeline

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

18 Apr 201817 Jan 2019

First posted12 Apr 2018
Study start18 Apr 2018
Primary completion1 Jun 2018
Study completion17 Jan 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03496701
Sponsor's protocol ID: EX-MKTG-86
Status last verified: Jun 2021
First submitted: 5 Apr 2018
Last updated: 30 Jun 2021
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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BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance of Wearers of MyDay Sphere Lenses After A Refit With MyDay Energys Lenses for One Week
ClinicalTrials.gov ID: NCT03496701
Acronym / sponsor ID: EX-MKTG-86
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 18 Apr 2018 (actual)
Primary completion: 1 Jun 2018 (actual)
Study completion: 17 Jan 2019 (actual)
First posted: 12 Apr 2018 (actual)
Results: Posted 29 Jun 2021

Clinical summary

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

The aim of this study is to determine if habitual or adapted wearers of stenfilcon A control contact lenses can be refit into test lenses and be successful after one week of daily wear.

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
Stenfilcon A / Test lens	Experimental	Device: Test lens, Device: control lensAll subjects will first wear stenfilcon A contact lenses for one week, then refitted with test contact lenses to wear for one week.

Who may qualify

Ages: 18 to 35 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Is between 18 and 35 years of age (inclusive)
Has read and signed the informed consent letter
Is willing and anticipated to follow instructions and maintain the appointment schedule
Habitually wears soft spherical contact lenses with a power between -1.00D to -6.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day.
Habitually wears or is able to be adequately refit into MyDay Sphere lenses

Key exclusion criteria (22 listed)

Is participating in any concurrent clinical research study
Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
Has a systemic condition that, in the opinion of the investigator, may affect the study measures
Is using any systemic or topical medications that in the opinion of the investigator may affect the study measures.
Presents with slit lamp findings or clinically significant anterior segment abnormalities that would contraindicate contact lens wear such as:

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: stenfilcon A Test lenscontact lens	Device	Stenfilcon A / Test lens
control lensAlso: stenfilcon A Control lenscontact lens	Device	Stenfilcon A / Test lens

Primary outcome

Overall Lens Fit Acceptance
Time frame: Baseline (After 10 minutes of lens dispense)
Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)
Overall Lens Fit Acceptance
Time frame: 1 week on each study lenses
Overall lens fit acceptance on a scale of 0-4, 0.5 steps (Scale: 0=should not be worn, 4=perfect)

4 secondary outcomes

Lens Centration
Time frame: Baseline - After 10 minutes of lens dispense
Lens Centration
Time frame: 1 week on each study lenses
Post-blink Movement
Time frame: Baseline (after 10 minutes of lens dispense)
Post-blink Movement
Time frame: 1 week on each study lenses

Results and safety

Results posted to the registry on 29 Jun 2021, 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 Study	77	77

Primary outcome: Overall Lens Fit Acceptance

Time frame: Baseline (After 10 minutes of lens dispense). Mean (Standard Deviation). Unit: units on a scale

Measure	Stenfilcon A Test Lens n = 77	Stenfilcon A Control Lens n = 77
Value	3.90 (0.26)	3.81 (0.34)

Primary outcome: Overall Lens Fit Acceptance

Time frame: 1 week on each study lenses. Mean (Standard Deviation). Unit: units on a scale

Measure	Stenfilcon A Test Lens n = 77	Stenfilcon A Control Lens n = 77
Value	3.79 (0.47)	3.83 (0.35)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From dispense up to 1 week on each study lenses, a total of 2 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stenfilcon A Test Lens	0 of 77 (0%)	0 of 77 (0%)	0 of 77
Stenfilcon A Control Lens	0 of 77 (0%)	0 of 77 (0%)	0 of 77

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Myopia

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

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 Ardaya principal investigator

Golden Optometric Group, CA

Shane Kannarr principal investigator

Kannarr Eye Care, KS

Michael Cymbor principal investigator

Nittany Eye Associates, PA

4 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 4 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 12 inclusion and 22 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 30 Jun 2021. 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. 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 29 Jun 2021). 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 Lens Fit Acceptance (time frame: Baseline (After 10 minutes of lens dispense)). 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 NCT03496701.

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 30 Jun 2021.