MyopiaNCT02248727

Clinical Performance of Existing Wearers of Avaira Sphere Following a Refit With Clariti Elite Sphere

A study testing somofilcon A in people with Myopia, run by CooperVision, Inc. at 1 site in Spain.

Completed

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

Trial summary

The aim of this dispensing study is to evaluate the clinical performance of existing wearers of Avaira sphere lenses following a refit with Clariti Elite sphere over 4 weeks of daily wear. Read more about this study

Who is it for?: Ages 18 to 40 years
Conditions the study is for: Myopia
What is being tested?: somofilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteSpain
Study dates: Sep 2014to 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 to 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Is between 18 and 40 years of age (inclusive)
Has had a self-reported visual exam in the last two years
Is an adapted Avaira sphere contact lens (CL) wearer (at least 1 week in Avaira sphere)
Has a contact lens spherical prescription between -1.00 to - 6.00 (inclusive)
Has a spectacle cylinder up to 0.75D in each eye.
Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.

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Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
Has clear corneas and no active ocular disease
Has read, understood and signed the information consent letter.
Patient contact lens refraction should fit within the available parameters of the study lenses.
Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
Is willing to comply with the visit schedule

Who cannot join

Is not a habitual wearer of Avaira sphere lenses
Has a contact lens prescription outside the range of the available parameters of the study lenses.
Has a spectacle cylinder ≥1.00D of cylinder in either eye.
Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
Presence of clinically significant (grade 2-4) anterior segment abnormalities

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Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
Slit lamp findings that would contraindicate contact lens wear such as:
Pathological dry eye or associated findings
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 (past or present)
Seborrheic eczema, Seborrheic conjunctivitis
History of corneal ulcers or fungal infections
Poor personal hygiene
Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
Has aphakia, keratoconus or a highly irregular cornea.
Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
Has undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Optometry Research Group (GIO) Optics Department, University of Valencia
Valencia, 46100

Other trials in Spain

About this study

Official title: Clinical Performance of Existing Wearers of Avaira Sphere (Enfilcon A) Following a Refit With Clariti Elite Sphere (Somofilcon A) Lenses for 4 Weeks

The aim of this dispensing study is to evaluate the clinical performance of existing wearers of Avaira sphere lenses following a refit with Clariti Elite sphere over 4 weeks of daily wear.

Read the detailed description

This is a 30-subject, prospective dispensing study comparing the clinical performance of the subjects' habitual Avaira sphere lenses following a refit with Clariti Elite sphere lenses. Subject's habitual Avaira sphere lenses will be evaluated at the first visit and then re-fitted with a pair of Clariti Elite sphere lenses for 4 weeks of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks and 4 weeks.

Conditions: Myopia
Being tested: somofilcon A
Medical subject headings: Myopia

What participants receive

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

somofilcon ADevice
somofilcon A lens

Study groups in NCT02248727
Study group	Role	What they receive
enfilcon A	Active comparator	All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens Receives: Device: somofilcon A
somofilcon A	Experimental	All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens Receives: Device: somofilcon A

What is being measured

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

Visual Acuity - Enfilcon A and Somofilcon A
Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.
Measured: Baseline, 1 Week, 2 Week, 4 Week
Subjective Assessments. - Enfilcon A and Somofilcon A
Subjective assessments for: comfort, dryness, handling, overall vision satisfaction, and eye whiteness. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall vision satisfaction (0=very unsatisfied; 10=very satisfied), habitual eye whiteness (0=not white; 10= totally white)
Measured: Baseline, 1 Week, 2 Week, 4 Week

Timeline

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

Sep 2014Dec 2014

First posted25 Sep 2014 (estimated)
Study startSep 2014
Primary completionOct 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: Non-randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02248727
Sponsor's protocol ID: EX-MKTG-52
Status last verified: Jul 2020
First submitted: 23 Sep 2014
Last updated: 28 Jul 2020
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

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Performance of Existing Wearers of Avaira Sphere (Enfilcon A) Following a Refit With Clariti Elite Sphere (Somofilcon A) Lenses for 4 Weeks
ClinicalTrials.gov ID: NCT02248727
Acronym / sponsor ID: EX-MKTG-52
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2014
Primary completion: Oct 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 25 Sep 2014 (estimated)
Results: Posted 23 Mar 2016

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 dispensing study is to evaluate the clinical performance of existing wearers of Avaira sphere lenses following a refit with Clariti Elite sphere over 4 weeks of daily wear.

Detailed description

Study design

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

Arm	Type	Receives
enfilcon A	Active comparator	Device: somofilcon AAll participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens
somofilcon A	Experimental	Device: somofilcon AAll participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Is between 18 and 40 years of age (inclusive)
Has had a self-reported visual exam in the last two years
Is an adapted Avaira sphere contact lens (CL) wearer (at least 1 week in Avaira sphere)
Has a contact lens spherical prescription between -1.00 to - 6.00 (inclusive)
Has a spectacle cylinder up to 0.75D in each eye.

Key exclusion criteria (21 listed)

Is not a habitual wearer of Avaira sphere lenses
Has a contact lens prescription outside the range of the available parameters of the study lenses.
Has a spectacle cylinder ≥1.00D of cylinder in either eye.
Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.

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
somofilcon Asomofilcon A lens	Device	enfilcon A, somofilcon A

Primary outcome

Visual Acuity - Enfilcon A and Somofilcon A
Time frame: Baseline, 1 Week, 2 Week, 4 Week
Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.
Subjective Assessments. - Enfilcon A and Somofilcon A
Time frame: Baseline, 1 Week, 2 Week, 4 Week
Subjective assessments for: comfort, dryness, handling, overall vision satisfaction, and eye whiteness. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall vision satisfaction (0=very unsatisfied; 10=very satisfied), habitual eye whiteness (0=not white; 10= totally white)

Results and safety

Results posted to the registry on 23 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enfilcon A / Somofilcon A	30	30

Primary outcome: Visual Acuity - Enfilcon A and Somofilcon A

Time frame: Baseline, 1 Week, 2 Week, 4 Week. Mean (Standard Deviation). Unit: logMar

Measure	Enfilcon A n = 30	Somofilcon A at 1 Week n = 30	Somofilcon A at 2 Week n = 30	Somofilcon A at 4 Week n = 30
OD	-0.037 (0.049)	-0.037 (0.049)	-0.037 (0.049)	-0.037 (0.049)
OS	-0.037 (0.049)	-0.037 (0.049)	-0.037 (0.049)	-0.037 (0.049)
Binocular	-0.067 (0.066)	-0.067 (0.066)	-0.067 (0.066)	-0.067 (0.066)

Primary outcome: Subjective Assessments. - Enfilcon A and Somofilcon A

Time frame: Baseline, 1 Week, 2 Week, 4 Week. Mean (Standard Deviation). Unit: units on a scale

Measure	Enfilcon A n = 30	Somofilcon A at 1 Week n = 30	Somofilcon A at 2 Week n = 30	Somofilcon A at 4 Week n = 30
Comfort on insertion	8.43 (0.77)	7.73 (0.83)	7.33 (0.76)	6.80 (0.81)
Comfort prior to removal	8.53 (0.73)	7.20 (1.16)	6.90 (1.03)	6.50 (0.94)
Overall comfort	8.47 (0.82)	7.40 (0.97)	7.07 (0.98)	6.60 (0.93)
Dryness during the day	8.33 (0.84)	8.17 (0.95)	7.63 (1.07)	6.97 (1.07)
Dryness prior to removal	8.47 (0.86)	7.77 (1.04)	7.27 (1.05)	6.80 (1.16)
Overall dryness	8.40 (0.89)	7.43 (1.07)	7.13 (0.97)	6.77 (1.14)
Handling	8.50 (0.68)	7.70 (1.15)	7.07 (0.94)	6.40 (0.93)
Overall vision satifaction	8.47 (0.78)	8.37 (0.81)	8.10 (0.92)	7.53 (0.78)

Adverse events

Time frame: 4 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enfilcon A to Somofilcon A	0 of 30 (0%)	0 of 30 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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
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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
Clinical Performance and Outcomes After Toric Lens Transition
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Recruiting
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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.

Robert Montés-Mico, O.D. principal investigator

Optometry Research Group (GIO) University of Valencia

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

Questions about this trial

What is this clinical trial studying?

A study testing somofilcon A in people with Myopia, run by CooperVision, Inc. at 1 site in Spain.

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 21 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 28 Jul 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 Spain. 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 23 Mar 2016). 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?

Visual Acuity - Enfilcon A and Somofilcon A (time frame: Baseline, 1 Week, 2 Week, 4 Week). 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 NCT02248727.

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 28 Jul 2020.