MyopiaNCT03235115

Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses

A study testing Methafilcon A IV, Ocufilcon B and Omafilcon A 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

This study aims to compare the short-term clinical performance of the three contact lenses (Methafilcon A IV, Ocufilcon B 1-day and Omafilcon A 1-day daily disposable). Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: Methafilcon A IV, Ocufilcon B and Omafilcon A
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited Kingdom
Study dates: 23 Jun 2017to 22 Sep 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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

They are of aged 18-40 and have capacity to volunteer.
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They agree not to participate in other clinical research for the duration of this study.
They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)
They have a spectacle cylindrical correction of -0.75D or less in each eye (based on the ocular refraction).
They can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
They currently use soft contact lenses or have done so in the previous six months.

Who cannot join

They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They have had cataract surgery.
They have had corneal refractive surgery.
They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

Show all 10Show fewer

They are pregnant or lactating.
They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Eurolens Research - The University of Manchester
Manchester, M13 9PL

Other trials in United Kingdom

About this study

This study aims to compare the short-term clinical performance of the three contact lenses (Methafilcon A IV, Ocufilcon B 1-day and Omafilcon A 1-day daily disposable).

Read the detailed description

This will be a randomized, double-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. Forty subjects will wear each lens brand for approximately one hour, on three separate study days in random order. Lenses will only be worn during study visits.

Conditions: Myopia
Being tested: Methafilcon A IV, Ocufilcon B, Omafilcon A
Medical subject headings: Myopia

What participants receive

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

Methafilcon A IVDevice
Contact Lens
Ocufilcon BDevice
Contact Lens
Omafilcon ADevice
Contact Lens

Study groups in NCT03235115
Study group	Role	What they receive
Methafilcon A IV	Active comparator	Subjects are randomized to wear Methafilcon A IV for 1 hour during the cross over study. Receives: Device: Ocufilcon B; Device: Omafilcon A
Ocufilcon B	Active comparator	Subjects are randomized to wear Ocufilcon B for 1 hour during the cross over study. Receives: Device: Methafilcon A IV; Device: Omafilcon A
Omafilcon A	Active comparator	Subjects are randomized to wear Omafilcon A for 1 hour during the cross over study. Receives: Device: Methafilcon A IV; Device: Ocufilcon B

What is being measured

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

Visual Acuity Using logMAR
Assessment of visual performance using the Bailey-Lovie logMAR visual acuity test chart and procedures for carrying out an over-refraction
Measured: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
Lens Fit - Horizontal Centration
Assessment of horizontal centration of lens on eye
Measured: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
Lens Fit - Vertical Centration
Assessment of vertical centration of lens on eye
Measured: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
Lens Fit - Corneal Coverage of Lens
Assessment of corneal coverage of lens on eye
Measured: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
Lens Fit - Movement of Lens
Assessment of movement of lens on eye
Measured: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn

Timeline

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

23 Jun 201722 Sep 2017

First posted1 Aug 2017
Study start23 Jun 2017
Primary completion22 Sep 2017
Study completion22 Sep 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
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03235115
Sponsor's protocol ID: EX-MKTG-85
Status last verified: Aug 2019
First submitted: 27 Jul 2017
Last updated: 12 Sep 2019
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

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 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses
ClinicalTrials.gov ID: NCT03235115
Acronym / sponsor ID: EX-MKTG-85
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: 23 Jun 2017 (actual)
Primary completion: 22 Sep 2017 (actual)
Study completion: 22 Sep 2017 (actual)
First posted: 1 Aug 2017 (actual)
Results: Posted 14 Nov 2018

Clinical summary

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

This study aims to compare the short-term clinical performance of the three contact lenses (Methafilcon A IV, Ocufilcon B 1-day and Omafilcon A 1-day daily disposable).

Detailed description

Study design

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

Arm	Type	Receives
Methafilcon A IV	Active comparator	Device: Ocufilcon B, Device: Omafilcon ASubjects are randomized to wear Methafilcon A IV for 1 hour during the cross over study.
Ocufilcon B	Active comparator	Device: Methafilcon A IV, Device: Omafilcon ASubjects are randomized to wear Ocufilcon B for 1 hour during the cross over study.
Omafilcon A	Active comparator	Device: Methafilcon A IV, Device: Ocufilcon BSubjects are randomized to wear Omafilcon A for 1 hour during the cross over study.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

They are of aged 18-40 and have capacity to volunteer.
They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
They are willing and able to follow the protocol.
They agree not to participate in other clinical research for the duration of this study.
They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive)

Key exclusion criteria (10 listed)

They have an ocular disorder which would normally contra-indicate contact lens wear.
They have a systemic disorder which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They have had cataract surgery.
They have had corneal refractive surgery.

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
Methafilcon A IVContact Lens	Device	Ocufilcon B, Omafilcon A
Ocufilcon BContact Lens	Device	Methafilcon A IV, Omafilcon A
Omafilcon AContact Lens	Device	Methafilcon A IV, Ocufilcon B

Primary outcome

Visual Acuity Using logMAR
Time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
Assessment of visual performance using the Bailey-Lovie logMAR visual acuity test chart and procedures for carrying out an over-refraction
Lens Fit - Horizontal Centration
Time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
Assessment of horizontal centration of lens on eye
Lens Fit - Vertical Centration
Time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
Assessment of vertical centration of lens on eye
Lens Fit - Corneal Coverage of Lens
Time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
Assessment of corneal coverage of lens on eye
Lens Fit - Movement of Lens
Time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn
Assessment of movement of lens on eye

Results and safety

Results posted to the registry on 14 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Methafilcon A IV, Ocufilcon B, Omafilcon A	9	9
Methafilcon A IV, Omafilcon A, Ocufilcon B	6	6
Ocufilcon B, Omafilcon A, Methafilcon A IV	7	7
Ocufilcon B, Methafilcon A IV, Omafilcon A	6	6
Omafilcon A, Ocufilcon B, Methafilcon A IV	6	6
Omafilcon A, Methafilcon A IV, Ocufilcon B	6	5

Primary outcome: Visual Acuity Using logMAR

Time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn. Mean (Standard Deviation). Unit: logMAR

Measure	Omafilcon A n = 40	Methafilcon A IV n = 39	Ocufilcon B n = 39
At Dispense	-0.14 (0.09)	-0.13 (0.07)	-0.13 (0.07)
Follow Up	-0.14 (0.07)	-0.14 (0.07)	-0.14 (0.07)

Primary outcome: Lens Fit - Horizontal Centration

Time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn. Count of participants. Unit: Participants

Measure	Omafilcon A n = 40	Methafilcon A IV n = 39	Ocufilcon B n = 39
At dispense: Extremely nasal	0	0	0
At dispense: Slightly nasal	1	1	1
At dispense: Optimum	23	17	26
At dispense: Slightly temporal	16	21	12
At dispense: Extremely temporal	0	0	0
At follow up: Extremely nasal	0	0	0
At follow up: Slightly nasal	1	2	0
At follow up: Optimum	22	14	26

Primary outcome: Lens Fit - Vertical Centration

Time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn. Count of participants. Unit: Participants

Measure	Omafilcon A n = 40	Methafilcon A IV n = 39	Ocufilcon B n = 39
At dispense: Extremely inferior	0	0	0
At dispense: Slightly inferior	12	6	9
At dispense: Optimum	20	9	27
At dispense: Slightly superior	8	24	3
At dispense: Extremely superior	0	0	0
At follow up: Extremely inferior	0	0	0
At follow up: Slightly inferior	15	4	11
At follow up: Optimum	18	14	26

Primary outcome: Lens Fit - Corneal Coverage of Lens

Time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn. Count of participants. Unit: Participants

Measure	Omafilcon A n = 40	Methafilcon A IV n = 39	Ocufilcon B n = 39
At dispense: Extremely inadequate	0	0	0
At dispense: Slightly inadequate	6	16	4
At dispense: Optimum	29	22	30
At dispense: Slightly excessive	5	1	5
At dispense: Extremely excessive	0	0	0
At follow up: Extremely inadequate	0	1	0
At follow up: Slightly inadequate	5	13	4
At follow up: Optimum	30	24	30

Adverse events

Time frame: Patients wore 3 different contact lenses for 1 hour on 3 different days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Omafilcon A	0 of 40 (0%)	0 of 40 (0%)	0 of 40
Methafilcon A IV	0 of 39 (0%)	0 of 39 (0%)	0 of 39
Ocufilcon B	0 of 39 (0%)	0 of 39 (0%)	0 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
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.

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 Methafilcon A IV, Ocufilcon B and Omafilcon A 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 8 inclusion and 10 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 12 Sep 2019. 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 14 Nov 2018). 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 Using logMAR (time frame: Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn). The study lists 5 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 NCT03235115.

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 12 Sep 2019.