MyopiaNCT02815735

Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses

A study testing comfilcon A and lotrafilcon B in people with Myopia, run by CooperVision, Inc. at 9 sites 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

The aim of this study is to compare the subjective performance of the comfilcon A contact lens against lotrafilcon B contact lens after 4 weeks of reusable lens wear. Read more about this study

Who is it for?: Ages 18 to 34 yearsHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: comfilcon A and lotrafilcon B
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 85 participants
Where: 9 sitesUnited Kingdom
Study dates: Aug 2016to Feb 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 34 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Spherical distance CL (Contact Lens) prescription between -1.00 and -6.00D (Diopter) OR in both eyes (inclusive)
Adapted soft CL wearers (i.e. >1 month) who are reusable lens wearers*
Spectacle cylinder 0.75D in both eyes
Correctable to 6/9 in both eyes
Be between 18 and 34 years of age (inclusive)
Able to read, comprehend and sign an informed consent
Own a mobile phone and be able to respond to SMS survey during the period 8am - 8pm
Willing to comply with the wear and study visit schedule

Who cannot join

Any of the following will render a subject ineligible for inclusion:
Existing wearer of daily disposable contact lenses
Known allergy to Opti-Free PureMoist multipurpose solution
Any active corneal infection, injury or inflammation
Systemic or ocular allergies, which might interfere with CL wear
Systemic disease, which might interfere with CL wear

Show all 15Show fewer

Ocular disease, which might interfere with CL wear
Strabismus or amblyopia
Subjects who have undergone corneal refractive surgery
Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
Pregnant, planning a pregnancy or lactating
Use of systemic/topical medication contraindicating CL wear
Diabetic
Site employees or family members of investigators
Participation in any concurrent trial or in the last 30 days

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United Kingdom9 sites

Boots Opticians Ltd
Birmingham, Warwickshire, B4 7TB
Tempany's Boutique Opticians
Broadstone, Dorset, BH18 8DP
Chalmers Opticians
Cardiff, Glamorgan, CF24 3RQ
Brock and Houlford
Chew Magna, Bristol, BS40 8PR
Visioncare Research Ltd.
Farnham, GU9 7EN
David Gould Opticians
Rawtenstall, Lancashire, BB4 7QN
Eyesite
Reading, Berkshire, RG1 1EX
Leightons
St Albans, Hertfordshire, AL1 3LH
Harrold Opticians
Uxbridge, Middlesex, UB8 1JX

Other trials in United Kingdom

About this study

The aim of this study is to compare the subjective performance of the comfilcon A contact lens against lotrafilcon B contact lens after 4 weeks of reusable lens wear.

Read the detailed description

This will be a 80 subject, randomized, bilateral, double-masked, dispensing, cross-over study comparing comfilcon A versus lotrafilcon B lenses over 4 weeks of daily wear for each lens pair.

Conditions: Myopia
Being tested: comfilcon A, lotrafilcon B
Medical subject headings: Myopia

What participants receive

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

comfilcon ADevice
contact lens
lotrafilcon BDevice
contact lens

Study groups in NCT02815735
Study group	Role	What they receive
comfilcon A	Experimental	Participants wear comfilcon A lens for 4 weeks during the cross over study. Receives: Device: comfilcon A
lotrafilcon B	Active comparator	Participants wear lotrafilcon B lens for 4 weeks during the cross over study. Receives: Device: lotrafilcon B

What is being measured

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

Comfort
Comfort (insertion, end of the day, and overall) for habitual lenses assessed at baseline and comfilcon A and lotrafilcon B lenses assessed at 2 weeks and 4 weeks. Scale 0-10, 0=painful, 10=can't feel the lenses.
Measured: Baseline, 2 weeks, 4 weeks
Comfort During the Day
Comfort during the day for comfilcon A and lotrafilcon B lenses assessed via via SMS (short message service) text message at days 3,12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale 0-10, 0=painful, 10=can't feel the lenses.
Measured: Days 3, 12, 26

Timeline

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

Aug 2016Feb 2017

First posted28 Jun 2016 (estimated)
Study startAug 2016
Primary completionJan 2017
Study completionFeb 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: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02815735
Sponsor's protocol ID: EX-MKTG-68 (VISA-407)
Status last verified: Mar 2017
First submitted: 24 Jun 2016
Last updated: 8 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
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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Study at a glance

From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-Centre Clinical Evaluation of Two Reusable Soft Contact Lenses
ClinicalTrials.gov ID: NCT02815735
Acronym / sponsor ID: EX-MKTG-68 (VISA-407)
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2016
Primary completion: Jan 2017 (actual)
Study completion: Feb 2017 (actual)
First posted: 28 Jun 2016 (estimated)
Results: Posted 8 May 2017

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 study is to compare the subjective performance of the comfilcon A contact lens against lotrafilcon B contact lens after 4 weeks of reusable lens wear.

Detailed description

This will be a 80 subject, randomized, bilateral, double-masked, dispensing, cross-over study comparing comfilcon A versus lotrafilcon B lenses over 4 weeks of daily wear for each lens pair.

Study design

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

Arm	Type	Receives
comfilcon A	Experimental	Device: comfilcon AParticipants wear comfilcon A lens for 4 weeks during the cross over study.
lotrafilcon B	Active comparator	Device: lotrafilcon BParticipants wear lotrafilcon B lens for 4 weeks during the cross over study.

Who may qualify

Ages: 18 to 34 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Spherical distance CL (Contact Lens) prescription between -1.00 and -6.00D (Diopter) OR in both eyes (inclusive)
Adapted soft CL wearers (i.e. >1 month) who are reusable lens wearers*
Spectacle cylinder 0.75D in both eyes
Correctable to 6/9 in both eyes
Be between 18 and 34 years of age (inclusive)

Key exclusion criteria (15 listed)

Existing wearer of daily disposable contact lenses
Known allergy to Opti-Free PureMoist multipurpose solution
Any active corneal infection, injury or inflammation
Systemic or ocular allergies, which might interfere with CL wear
Systemic disease, which might interfere with CL wear

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
comfilcon Acontact lens	Device	comfilcon A
lotrafilcon Bcontact lens	Device	lotrafilcon B

Primary outcome

Comfort
Time frame: Baseline, 2 weeks, 4 weeks
Comfort (insertion, end of the day, and overall) for habitual lenses assessed at baseline and comfilcon A and lotrafilcon B lenses assessed at 2 weeks and 4 weeks. Scale 0-10, 0=painful, 10=can't feel the lenses.
Comfort During the Day
Time frame: Days 3, 12, 26
Comfort during the day for comfilcon A and lotrafilcon B lenses assessed via via SMS (short message service) text message at days 3,12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale 0-10, 0=painful, 10=can't feel the lenses.

Results and safety

Results posted to the registry on 8 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Comfilcon A, Then Lotrafilcon B	36	34
Lotrafilcon B, Then Comfilcon A	38	37

Primary outcome: Comfort

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

Measure	Habitual (Baseline) n = 73	Comfilcon A (2 Weeks) n = 71	Lotrafilcon B (2 Weeks) n = 69	Comfilcon A (4 Weeks) n = 70	Lotrafilcon B (4 Weeks) n = 70
Comfort on insertion	8.90 (1.38)	9.03 (1.10)	8.70 (1.57)	8.74 (1.25)	8.60 (1.62)
Overall comfort	8.86 (1.38)	8.13 (1.69)	8.43 (1.54)	8.11 (1.57)	8.24 (1.65)
End-of-Day Comfort	8.03 (1.78)	7.31 (2.21)	7.45 (2.23)	7.23 (2.17)	7.34 (2.34)

Primary outcome: Comfort During the Day

Time frame: Days 3, 12, 26. Mean (Standard Deviation). Unit: units on a scale

Measure	Comfilcon A (Day 3) n = 69	Lotrafilcon B (Day 3) n = 69	Comfilcon A (Day 12) n = 72	Lotrafilcon B (Day 12) n = 70	Comfilcon A (Day 26) n = 70	Lotrafilcon B (Day 26) n = 68
8:00 am	8.98 (1.34)	8.78 (1.60)	8.67 (1.21)	8.96 (1.26)	8.78 (1.00)	8.59 (1.48)
12:00 pm	8.94 (1.48)	8.95 (1.22)	8.59 (1.26)	8.73 (1.41)	8.72 (1.39)	8.60 (1.32)
4:00 pm	8.51 (1.58)	8.74 (1.31)	8.51 (1.49)	8.70 (1.45)	8.31 (1.56)	8.27 (1.62)
8:00 pm	8.15 (1.94)	8.14 (1.59)	7.91 (1.89)	8.25 (1.77)	7.85 (1.70)	7.89 (1.92)

Population analysed: Missing data from one participant.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Comfilcon A	0 of 74 (0%)	0 of 74 (0%)	0 of 74
Lotrafilcon B	0 of 74 (0%)	0 of 74 (0%)	0 of 74

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
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.

Graeme Young study director

Visioncare Research Ltd.

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

Questions about this trial

What is this clinical trial studying?

A study testing comfilcon A and lotrafilcon B in people with Myopia, run by CooperVision, Inc. at 9 sites 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 15 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 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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 8 May 2017). 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?

Comfort (time frame: Baseline, 2 weeks, 4 weeks). 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 NCT02815735.

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 8 May 2017.