MyopiaNCT04709237

Evaluation of The Clinical Acceptance of Soft Contact Lenses for Myopia Control

A study testing omafilcon A test lens 1 and omafilcon A test lens 2 in people with Myopia, run by CooperVision, Inc. at 1 site in United Kingdom.

Completed

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

Official record

Search all trials

Trial summary

The main objective of the study was to evaluate the clinical acceptance of soft contact lenses for Myopia control. Read more about this study

Who is it for?: Ages 10 to 16 yearsHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: omafilcon A test lens 1 and omafilcon A test lens 2
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited Kingdom
Study dates: 14 Dec 2019to 31 Mar 2021
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 10 to 16 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Age 10 to 16 years;
Spectacle refraction: -0.75 to -6.00D spherical equivalent, maximum anisometropia 1.25D, cylinder up to -1.00DC
Best corrected visual acuity of at least 20/25 in each eye.
Parents/guardians and participant have read and understood the Participant Information Sheet;
Parents/guardians and participant have read, signed and dated the Informed Consent;
Have normal eyes with the exception of the need for visual correction;
Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule.

Who cannot join

Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
Newly prescribed use of some systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
Monocular participants (only one eye with functional vision) or participants fit with only one lens;
Subjects with slit lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit;
History of herpetic keratitis, ocular surgery or irregular cornea;
Enrolment of the family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Ocular Technology Group - International
London, SW1E 6AU

Other trials in United Kingdom

About this study

The main objective of the study was to evaluate the clinical acceptance of soft contact lenses for Myopia control.

Read the detailed description

Participants were randomized to wear each study contact lenses for 10 days with investigator and participant masking. The participants who are not contact lens wearer at enrollment wore single vision contact lenses for two weeks during the pre-investigation phase to get adapted to contact lens wear.

Conditions: Myopia
Being tested: omafilcon A control lens, omafilcon A test lens 1, omafilcon A test lens 2
Medical subject headings: Myopia

What participants receive

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

omafilcon A control lensDevice
Participants were randomized to wear omafilcon A control soft contact lens for 10 days.
omafilcon A test lens 1Device
Participants were randomized to wear omafilcon A test soft contact lens 1 for 10 days.
omafilcon A test lens 2Device
Participants were randomized to wear omafilcon A test soft contact lens 2 for 10 days.

Study groups in NCT04709237
Study group	Role	What they receive
Omafilcon A Control Lens first, then Omafilcon A Test Lens 1, then Omafilcon A Test Lens 2	Experimental	Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types. Receives: Device: omafilcon A control lens; Device: omafilcon A test lens 1; Device: omafilcon A test lens 2
Omafilcon A Test Lens 2 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 1	Experimental	Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types. Receives: Device: omafilcon A control lens; Device: omafilcon A test lens 1; Device: omafilcon A test lens 2
Omafilcon A Test Lens 1 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 2	Experimental	Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types. Receives: Device: omafilcon A control lens; Device: omafilcon A test lens 1; Device: omafilcon A test lens 2

What is being measured

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

Overall Vision Satisfaction
Overall vision satisfaction recorded on a visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy)
Measured: 10 days
Habitual Daily Wearing Time
Habitual daily wearing time in hours
Measured: 10 days

Secondary outcomes (5)

Visual Acuity
Visual acuity measured using logMAR
Measured: 10 days
Overall Visual Satisfaction During the Use of iPad With White Screen
Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy)
Measured: 10 days
Visual Satisfaction During the Use of Ipad With White Screen- How Clear is the Close-up Vision.
Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Clear at All, 100 - Very Clear)
Measured: 10 Days
Visual Satisfaction During the Use of iPad With Black Screen- How Happy the Vision is.
Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy)
Measured: 10 Days
Visual Satisfaction During the Use of Ipad With Black Screen- How Clear is the Close-up the Vision is.
Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Clear at All, 100 - Very Clear)
Measured: 10 Days

Timeline

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

14 Dec 201931 Mar 2021

First posted14 Jan 2021
Study start14 Dec 2019
Primary completion31 Mar 2021
Study completion31 Mar 2021

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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04709237
Sponsor's protocol ID: CV-20-51
Status last verified: Apr 2022
First submitted: 12 Jan 2021
Last updated: 27 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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

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

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of The Clinical Acceptance of Soft Contact Lenses for Myopia Control
ClinicalTrials.gov ID: NCT04709237
Acronym / sponsor ID: CV-20-51
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 14 Dec 2019 (actual)
Primary completion: 31 Mar 2021 (actual)
Study completion: 31 Mar 2021 (actual)
First posted: 14 Jan 2021 (actual)
Results: Posted 27 Aug 2024

Clinical summary

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

The main objective of the study was to evaluate the clinical acceptance of soft contact lenses for Myopia control.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Omafilcon A Control Lens first, then Omafilcon A Test Lens 1, then Omafilcon A Test Lens 2	Experimental	Device: omafilcon A control lens, Device: omafilcon A test lens 1, Device: omafilcon A test lens 2Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types.
Omafilcon A Test Lens 2 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 1	Experimental	Device: omafilcon A control lens, Device: omafilcon A test lens 1, Device: omafilcon A test lens 2Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types.
Omafilcon A Test Lens 1 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 2	Experimental	Device: omafilcon A control lens, Device: omafilcon A test lens 1, Device: omafilcon A test lens 2Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types.

Who may qualify

Ages: 10 to 16 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (7 listed)

Age 10 to 16 years;
Spectacle refraction: -0.75 to -6.00D spherical equivalent, maximum anisometropia 1.25D, cylinder up to -1.00DC
Best corrected visual acuity of at least 20/25 in each eye.
Parents/guardians and participant have read and understood the Participant Information Sheet;
Parents/guardians and participant have read, signed and dated the Informed Consent;

Key exclusion criteria (6 listed)

Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
Newly prescribed use of some systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
Monocular participants (only one eye with functional vision) or participants fit with only one lens;
Subjects with slit lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit;
History of herpetic keratitis, ocular surgery or irregular cornea;

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
omafilcon A control lensParticipants were randomized to wear omafilcon A control soft contact lens for 10 days.	Device	Omafilcon A Control Lens first, then Omafilcon A Test Lens 1, then Omafilcon A Test Lens 2, Omafilcon A Test Lens 1 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 2, Omafilcon A Test Lens 2 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 1
omafilcon A test lens 1Participants were randomized to wear omafilcon A test soft contact lens 1 for 10 days.	Device	Omafilcon A Control Lens first, then Omafilcon A Test Lens 1, then Omafilcon A Test Lens 2, Omafilcon A Test Lens 1 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 2, Omafilcon A Test Lens 2 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 1
omafilcon A test lens 2Participants were randomized to wear omafilcon A test soft contact lens 2 for 10 days.	Device	Omafilcon A Control Lens first, then Omafilcon A Test Lens 1, then Omafilcon A Test Lens 2, Omafilcon A Test Lens 1 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 2, Omafilcon A Test Lens 2 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 1

Primary outcome

Overall Vision Satisfaction
Time frame: 10 days
Overall vision satisfaction recorded on a visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy)
Habitual Daily Wearing Time
Time frame: 10 days
Habitual daily wearing time in hours

5 secondary outcomes

Visual Acuity
Time frame: 10 days
Overall Visual Satisfaction During the Use of iPad With White Screen
Time frame: 10 days
Visual Satisfaction During the Use of Ipad With White Screen- How Clear is the Close-up Vision.
Time frame: 10 Days
Visual Satisfaction During the Use of iPad With Black Screen- How Happy the Vision is.
Time frame: 10 Days
Visual Satisfaction During the Use of Ipad With Black Screen- How Clear is the Close-up the Vision is.
Time frame: 10 Days

Results and safety

Results posted to the registry on 27 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Omafilcon A Control Lens First, Then Omafilcon A Test Lens 1, Then Omafilcon A Test Lens 2	7	6
Omafilcon A Test Lens 2 First, Then Omafilcon A Control Lens , Then Omafilcon A Test Lens 1	7	7
Omafilcon A Test Lens 1 First, Then Omafilcon A Control Lens , Then Omafilcon A Test Lens 2	7	7

Primary outcome: Overall Vision Satisfaction

Time frame: 10 days. Mean (Standard Deviation). Unit: units on a scale

Measure	Omafilcon A Control Lens n = 19	Omafilcon A Test Lens 1 n = 19	Omafilcon A Test Lens 2 n = 19
Value	87.7 (12.1)	79.7 (16.5)	71.8 (27.3)

Population analysed: 19 total participants were analyzed out of the 20 participants. One participant was not included in the study because of the compliance issue (Did not complete required hours with lens).

Primary outcome: Habitual Daily Wearing Time

Time frame: 10 days. Mean (Standard Deviation). Unit: Hours/Day

Measure	Omafilcon A Control Lens n = 19	Omafilcon A Test Lens 1 n = 19	Omafilcon A Test Lens 2 n = 19
Value	7.9 (2.0)	8.1 (2.2)	7.8 (2.3)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Duration of all three study lens wear for approximately 30 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Omafilcon A Control Lens	0 of 19 (0%)	2 of 19 (10.5%)	0 of 19
Omafilcon A Test Lens 1	0 of 19 (0%)	0 of 19 (0%)	0 of 19
Omafilcon A Test Lens 2	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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
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.

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 omafilcon A test lens 1 and omafilcon A test lens 2 in people with Myopia, run by CooperVision, Inc. at 1 site in United Kingdom.

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 7 inclusion and 6 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 27 Aug 2024. 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 Kingdom. 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 27 Aug 2024). 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 Vision Satisfaction (time frame: 10 days). 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 NCT04709237.

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 27 Aug 2024.