MyopiaNCT01965262

A Clinical Assessment of the Hemacopolymer Daily Disposable Limbal Ring Soft Contact Lens

A study testing Hema-copolymer Lens and etafilcon A Lens 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

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Trial summary

This purpose of this study is to compare the clinical performance and subjective acceptance of two different daily disposable limbal ring lenses. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia
What is being tested?: Hema-copolymer Lens and etafilcon A Lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited Kingdom
Study dates: Apr 2014to Oct 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects will only be eligible for the study if:
They are 18 years of age and above.
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 can attain at least 6/9 in each eye with the study lenses within the available power range.
They can be fitted with study lenses within the available power range.
The currently use soft contact lenses, or have done so within the last six months.

Who cannot join

Subjects will not be able to take part in the study if:
They have an ocular disorder which would normally contraindicate contact lens wear.
They have a systemic disorder which would normally contraindicate 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.

Show all 11Show fewer

They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
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 normally contraindicate contact lens wear, or may, in the opinion of the investigator, pose a risk to study personnel; or any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reactions.
They have taken part in any other 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 purpose of this study is to compare the clinical performance and subjective acceptance of two different daily disposable limbal ring lenses.

Read the detailed description

This is a subject-masked, dispensing study designed to evaluate the clinical performance and subjective acceptance when comparing two different daily disposable limbal ring lenses. Limbal ring lenses, which as well as correcting vision, have a colored ring which enhance the wearer's iris and are particularly popular in East Asian countries.

Conditions: Myopia
Being tested: Hema-copolymer Lens, etafilcon A Lens
Medical subject headings: Myopia

What participants receive

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

Hema-copolymer LensDevice
contact lens
etafilcon A LensDevice
contact lens

Study groups in NCT01965262
Study group	Role	What they receive
Hema-copolymer Lens	Active comparator	Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study. Receives: Device: Hema-copolymer Lens; Device: etafilcon A Lens
etafilcon A Lens	Active comparator	Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study. Receives: Device: Hema-copolymer Lens; Device: etafilcon A Lens

What is being measured

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

Visual Acuity - Hema-copolymer and Etafilcon A
Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline.
Measured: Baseline
Visual Acuity - Hema-copolymer and Etafilcon A
Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week.
Measured: 1 week
Biomicroscopy - Hema-copolymer and Etafilcon A
Biomicroscopy is analyzed for hema-copolymer and etafilcon A at 1 week. (Scale 0-4, 0=normal, 4=severe).
Measured: 1 week
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.
Measured: Baseline
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.
Measured: 1 week
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.
Measured: Baseline
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.
Measured: 1 week
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Lens surface of wettability for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.
Measured: Baseline
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Lens surface of wettability for hema-copolymer and etafilcon A pair lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.
Measured: 1 week
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal
Measured: Baseline
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal
Measured: 1 week
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior
Measured: Baseline
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior
Measured: 1 week
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Measured: Baseline
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Measured: 1 week
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Measured: Baseline
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Measured: 1 week
Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of comfort preference for hema-copolymer and etafilcon A assessed at baseline. Scale 0-100, 0=causes pain, 100= excellent.
Measured: Baseline
Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of comfort preference after insertion and before removal for hema-copolymer and etafilcon A lenses is assessed at 1 week. Scale 0-100, 0=causes pain, 100= excellent.
Measured: 1 week
Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.
Measured: Baseline
Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.
Measured: 1 week
Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of peripheral blur is assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.
Measured: Baseline
Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of peripheral blur assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.
Measured: 1 week
Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of ocular redness for hema-copolymer and etafilcon A lenses lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Measured: 1 week
Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of handling (ease of insertion and ease of removal) for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unmanageable, 100= excellent.
Measured: 1 week
Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.
Measured: Baseline
Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Measured: 1 week
Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.
Measured: Baseline
Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Measured: 1 week

Timeline

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

Apr 2014Oct 2014

First posted18 Oct 2013 (estimated)
Study startApr 2014
Primary completionMay 2014
Study completionOct 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: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01965262
Sponsor's protocol ID: CV13-545
Status last verified: Feb 2017
First submitted: 11 Oct 2013
Last updated: 16 Mar 2017
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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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
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Recruiting
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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Assessment of the Hemacopolymer Daily Disposable Limbal Ring Soft Contact Lens
ClinicalTrials.gov ID: NCT01965262
Acronym / sponsor ID: CV13-545
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Apr 2014
Primary completion: May 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 18 Oct 2013 (estimated)
Results: Posted 18 Apr 2016

Clinical summary

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

This purpose of this study is to compare the clinical performance and subjective acceptance of two different daily disposable limbal ring lenses.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Hema-copolymer Lens	Active comparator	Device: Hema-copolymer Lens, Device: etafilcon A LensParticipants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.
etafilcon A Lens	Active comparator	Device: Hema-copolymer Lens, Device: etafilcon A LensParticipants were randomized to wear the etafilcon A lens pair for one week during the cross over study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

They are 18 years of age and above.
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 can attain at least 6/9 in each eye with the study lenses within the available power range.

Key exclusion criteria (11 listed)

They have an ocular disorder which would normally contraindicate contact lens wear.
They have a systemic disorder which would normally contraindicate 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
Hema-copolymer Lenscontact lens	Device	Hema-copolymer Lens, etafilcon A Lens
etafilcon A Lenscontact lens	Device	Hema-copolymer Lens, etafilcon A Lens

Primary outcome

Visual Acuity - Hema-copolymer and Etafilcon A
Time frame: Baseline
Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline.
Visual Acuity - Hema-copolymer and Etafilcon A
Time frame: 1 week
Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week.
Biomicroscopy - Hema-copolymer and Etafilcon A
Time frame: 1 week
Biomicroscopy is analyzed for hema-copolymer and etafilcon A at 1 week. (Scale 0-4, 0=normal, 4=severe).
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Time frame: Baseline
Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Time frame: 1 week
Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Time frame: Baseline
Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Time frame: 1 week
Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Time frame: Baseline
Lens surface of wettability for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Time frame: 1 week
Lens surface of wettability for hema-copolymer and etafilcon A pair lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Time frame: Baseline
Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Time frame: 1 week
Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Time frame: Baseline
Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Time frame: 1 week
Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Time frame: Baseline
Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Time frame: 1 week
Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Time frame: Baseline
Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Time frame: 1 week
Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time frame: Baseline
Subjective Assessment of comfort preference for hema-copolymer and etafilcon A assessed at baseline. Scale 0-100, 0=causes pain, 100= excellent.
Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time frame: 1 week
Subjective Assessment of comfort preference after insertion and before removal for hema-copolymer and etafilcon A lenses is assessed at 1 week. Scale 0-100, 0=causes pain, 100= excellent.
Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time frame: Baseline
Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.
Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time frame: 1 week
Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.
Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time frame: Baseline
Subjective Assessment of peripheral blur is assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.
Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time frame: 1 week
Subjective Assessment of peripheral blur assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.
Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time frame: 1 week
Subjective Assessment of ocular redness for hema-copolymer and etafilcon A lenses lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time frame: 1 week
Subjective Assessment of handling (ease of insertion and ease of removal) for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unmanageable, 100= excellent.
Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time frame: Baseline
Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.
Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time frame: 1 week
Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time frame: Baseline
Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.
Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A
Time frame: 1 week
Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.

Results and safety

Results posted to the registry on 18 Apr 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
Hema-copolymer Lens, Then Etafilcon A Lens	15	15
Etafilcon A Lens, Then Hema-copoloymer Lens	15	15

Primary outcome: Visual Acuity - Hema-copolymer and Etafilcon A

Time frame: Baseline. Mean (Standard Deviation). Unit: logMAR

Measure	Hema-copolymer Lens n = 30	Etafilcon A Lens n = 30
High Contrast	-0.08 (0.09)	-0.04 (0.09)
Low Contrast	0.17 (0.10)	0.20 (0.14)

Population analysed: All 30 subjects were dispensed lenses, and visual acuity measurements were obtained at baseline.

Primary outcome: Visual Acuity - Hema-copolymer and Etafilcon A

Time frame: 1 week. Mean (Standard Deviation). Unit: logMAR

Measure	Hema-copolymer Lens n = 28	Etafilcon A Lens n = 20
High Contrast	-0.08 (0.10)	-0.04 (0.10)
Low Contrast	0.18 (0.09)	0.23 (0.10)

Population analysed: 11 subjects discontinued the study. Missing data of 1 subject for hema-copolymer group.

Primary outcome: Biomicroscopy - Hema-copolymer and Etafilcon A

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

Measure	Hema-copolymer Lens n = 29	Etafilcon A Lens n = 20
Conjunctival hyperaemia	0.96 (0.18)	0.96 (0.19)
Limbal hyperameia	0.86 (0.27)	0.79 (0.25)
Corneal vascularisation	0.10 (0.22)	0.11 (0.26)
Microcysts	0.00 (0.00)	0.00 (0.00)
Oedema	0.00 (0.00)	0.00 (0.00)
Corenal Staining	0.26 (0.41)	0.44 (0.55)
Conjunctival Staining	0.37 (0.28)	0.33 (0.34)
Papillary Conjunctivitis	0.87 (0.35)	0.84 (0.37)

Population analysed: 11 subjects discontinued the study.

Primary outcome: Lens Surface - Deposition - Hema-copolymer and Etafilcon A

Time frame: Baseline. Number. Unit: participants

Measure	Hema-copolymer Lens n = 30	Etafilcon A Lens n = 30
Grade 0	29	30
Grade 1	1	0
Grade 2	0	0
Grade 3	0	0
Grade 4	0	0

Population analysed: All 30 subjects were dispensed lenses, and lens surface of deposition measurements were obtained at baseline.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hema-copolymer Lens	0 of 19 (0%)	1 of 19 (5.3%)	Not reported
Etafilcon A Lens	0 of 19 (0%)	0 of 19 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Carole Maldonado-Codinal, PhD principal investigator

Eurolens Research

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

Questions about this trial

What is this clinical trial studying?

A study testing Hema-copolymer Lens and etafilcon A Lens 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 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 16 Mar 2017. 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 18 Apr 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 - Hema-copolymer and Etafilcon A (time frame: Baseline). The study lists 29 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 NCT01965262.

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 16 Mar 2017.