MyopiaNCT03306641

A One-Week Crossover Dispensing Evaluation of New Daily Wear Soft Contact Lenses

A study testing Test Contact Lens and Nelfilcon A in people with Myopia, run by CooperVision, Inc. at 1 site in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period 1 week compared to nelfilcon A (control). Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Myopia
What is being tested?: Test Contact Lens and Nelfilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteUnited States
Study dates: 28 Jul 2017to 31 Aug 2017
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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Is at least 18 years of age and has full legal capacity to volunteer.
Is no greater than 55 years of age.
Has read and understood the information consent letter.
Is willing and able to follow instructions and maintain the appointment schedule.
Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study.
Has spectacle cylinder ≤1.00D in both eyes.

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Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.
Wears CLs in both eyes (monvision acceptable, but not monofit)
Has clear corneas and no active ocular disease.
Has not worn lenses for at least 12 hours before the examination.
Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week

Who cannot join

Has never worn contact lenses before.
Has any systemic disease affecting ocular health.
Is using any systemic or topical medications that will affect ocular health.
Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
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.

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Is aphakic.
Has strabismus/amblyopia.
Has undergone corneal refractive surgery.
Is pregnant, lactating or planning a pregnancy.
Is participating in any concurrent clinical or research study.

Trial locations and contacts

1 site in 1 country.

United States1 site

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 One-Week Crossover Dispensing Evaluation of Gemini Daily Wear Soft Contact Lenses

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period 1 week compared to nelfilcon A (control).

Read the detailed description

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 1 week compared to nelfilcon A (control). The primary outcomes of interest is lens fit acceptance.

Conditions: Myopia
Being tested: Test Contact Lens, Nelfilcon A
Medical subject headings: Myopia

What participants receive

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

Test Contact LensDevice
Daily disposable contact lens
Nelfilcon ADevice
Focus Dailies All Day Comfort contact lens (nelfilcon A)

Study groups in NCT03306641
Study group	Role	What they receive
Test Contact Lens	Active comparator	Per randomized schedule, subject will wear a pair of the test lens or control lens for one week and then cross-over with the control pair for 1 week. Receives: Device: Test Contact Lens; Device: Nelfilcon A
nelfilcon A lens (control)	Active comparator	Per randomized schedule, subject will wear a pair of the control lens for one week and then cross-over with the test pair for 1 week. Receives: Device: Test Contact Lens; Device: Nelfilcon A

What is being measured

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

Lens Fit Acceptance
Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Measured: Baseline
Lens Fit Acceptance
Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Measured: 1-Week

Timeline

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

28 Jul 201731 Aug 2017

First posted11 Oct 2017
Study start28 Jul 2017
Primary completion31 Aug 2017
Study completion31 Aug 2017

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 double-masked, bilateral, 1-week crossover, dispensing study, comparing the test daily wear lens against nelfilcon A control lens, such that each lens type will be worn for 1 week each. Each subject will be randomized to wear either the test lenses or the control lenses as a matched pair.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03306641
Sponsor's protocol ID: CV-17-29
Status last verified: Sep 2020
First submitted: 15 Aug 2017
Last updated: 22 Sep 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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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A One-Week Crossover Dispensing Evaluation of Gemini Daily Wear Soft Contact Lenses
ClinicalTrials.gov ID: NCT03306641
Acronym / sponsor ID: CV-17-29
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 28 Jul 2017 (actual)
Primary completion: 31 Aug 2017 (actual)
Study completion: 31 Aug 2017 (actual)
First posted: 11 Oct 2017 (actual)
Results: Posted 22 Sep 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 validate the clinical performance of a new contact lens design when worn over a period 1 week compared to nelfilcon A (control).

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 double-masked, bilateral, 1-week crossover, dispensing study, comparing the test daily wear lens against nelfilcon A control lens, such that each lens type will be worn for 1 week each. Each subject will be randomized to wear either the test lenses or the control lenses as a matched pair.

Arm	Type	Receives
Test Contact Lens	Active comparator	Device: Test Contact Lens, Device: Nelfilcon APer randomized schedule, subject will wear a pair of the test lens or control lens for one week and then cross-over with the control pair for 1 week.
nelfilcon A lens (control)	Active comparator	Device: Test Contact Lens, Device: Nelfilcon APer randomized schedule, subject will wear a pair of the control lens for one week and then cross-over with the test pair for 1 week.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Is at least 18 years of age and has full legal capacity to volunteer.
Is no greater than 55 years of age.
Has read and understood the information consent letter.
Is willing and able to follow instructions and maintain the appointment schedule.
Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study.

Key exclusion criteria (11 listed)

Has never worn contact lenses before.
Has any systemic disease affecting ocular health.
Is using any systemic or topical medications that will affect ocular health.
Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.

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 Contact LensDaily disposable contact lens	Device	Test Contact Lens, nelfilcon A lens (control)
Nelfilcon AFocus Dailies All Day Comfort contact lens (nelfilcon A)	Device	Test Contact Lens, nelfilcon A lens (control)

Primary outcome

Lens Fit Acceptance
Time frame: Baseline
Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Lens Fit Acceptance
Time frame: 1-Week
Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)

Results and safety

Results posted to the registry on 22 Sep 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 Contact Lens Then Nelfilcon A Lens (Control)	23	23
Nelfilcon A Lens (Control) Then Test Contact Lens	22	22

Primary outcome: Lens Fit Acceptance

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

Measure	Test Contact Lens n = 45	Nelfilcon A Lens (Control) n = 45
Value	2.6 (0.6)	3.1 (0.3)

Primary outcome: Lens Fit Acceptance

Time frame: 1-Week. Mean (Standard Deviation). Unit: units on a scale

Measure	Test Contact Lens n = 45	Nelfilcon A Lens (Control) n = 45
Value	2.6 (0.6)	3.0 (0.4)

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Test Contact Lens	0 of 45 (0%)	0 of 45 (0%)	0 of 45
Nelfilcon A Lens (Control)	0 of 45 (0%)	0 of 45 (0%)	0 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Test Contact Lens and Nelfilcon A in people with Myopia, run by CooperVision, Inc. at 1 site 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 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 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 22 Sep 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?

Lens Fit Acceptance (time frame: Baseline). 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 NCT03306641.

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 22 Sep 2020.