Presbyopia CorrectionNCT02147093

CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation

A study testing Test (multi-focal) in people with Presbyopia Correction, run by Johnson & Johnson Vision Care, 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

A comparative evaluation of a newly marketed multifocal contact lens with a single vision contact lens when used with near vision spectacles. The evaluation was to quantify the difference between the two test corrections. Read more about this study

Who is it for?: Ages 45 years and olderHealthy volunteers can take part
Conditions the study is for: Presbyopia Correction
What is being tested?: Test (multi-focal)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteUnited Kingdom
Study dates: 1 May 2014to 1 Aug 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 45 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age 45 years or more
Spectacle or soft contact lens wearer
Refraction: best sphere (corrected for back vertex distance) -6.00 Diopters (D) to +4.00 D; Astigmatism - 0.00 D to -0.75 D; Near addition for 40 cm; Medium Add: +1.50 D to +2.00 D; High Add: +2.25 D to +2.50 D
Best spectacle corrected visual acuity of 6/9 or better in each eye
Willingness to adhere to the instructions set forth in the clinical protocol
Signature of the subject Informed Consent form after review of Information to Participant document.

Who cannot join

Systemic or ocular allergies which might interfere with contact lens wear
Systemic disease which might interfere with contact lens wear
Ocular disease which might interfere with contact lens wear (e.g. hypothesia, insufficient lacrimal secretion)
Use of medication which might interfere with contact lens wear
Active ocular infection
Use of ocular medication

Show all 14Show fewer

Significant ocular anomaly
Presence of two or more corneal scars in either eye
Monovision contact lens wearers
Pregnancy or lactation
Any medical condition that might be prejudicial to the study
Participants non-able to give consent or from a vulnerable group
Infectious disease (for example, hepatitis, tuberculosis, etc.) or a contagious immunosuppressive disease (such as HIV, AIDS, etc.)
Employees or family member of the investigational clinic (e.g. investigator, coordinator, technician)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Study site
London, SW1E6AU

Other trials in United Kingdom

About this study

Conditions: Presbyopia Correction
Being tested: Test (multi-focal), Control (Sphere)

What participants receive

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

Test (multi-focal)Device
Also called Clariti 1 Day, filcon II 3
contact lens was to be worn a daily wear.
Control (Sphere)Device
Also called filcon II 3
contact lens was to be worn a daily wear with spectacles

Study groups in NCT02147093
Study group	Role	What they receive
Control (sphere) /Test (multi-focal)	Other	Subjects were first fitted with Control lens (sphere) and a pair of reading glasses for one week. Subjects were then fitted with the Test lens (multi-focal) for one week. Receives: Device: Test (multi-focal); Device: Control (Sphere)
Test (sphere) /Control (multi-focal)	Other	Subjects were first fitted with the Test lens (multi-focal) for one week. Subjects were then fitted with Control lens (sphere) and a pair of reading glasses for one week. Receives: Device: Test (multi-focal); Device: Control (Sphere)

What is being measured

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

Distance LogMAR Visual Acuity
Distance time controlled LogMAR (Logarithm of the Minimum Angle of Resolution) Visual Acuity was carried out binocularly, at 4m (meter) under 250 cd/m^2 and 2.5 cd/m^2 (candela per square meter) luminance. The test was presented under the two conditions; High luminance (250 cd/m^2) High Contrast (90%) \& Low Contrast (10%) and Low Luminance (2.5 cd/m^2) High Contrast (90%)
Measured: 7 days post wear
Near LogMAR Visual Acuity
Near time controlled LogMAR Visual Acuity was carried out binocularly, at 4cm under 250 cd/m^2 and 50 cd/m^2 luminance. The test was presented on under the two conditions; High Luminance (250cd/m^2) High Contrast (90%) \& Low Contrast (10%) and Low Luminance (50cd/m^2) High Contrast (90%)
Measured: 7 days post wear

Timeline

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

1 May 20141 Aug 2014

First posted26 May 2014 (estimated)
Study start1 May 2014
Primary completion1 Aug 2014
Study completion1 Aug 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 Presbyopia CorrectionStudies 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: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02147093
Sponsor's protocol ID: CR-5175
Status last verified: Jun 2017
First submitted: 21 May 2014
Last updated: 19 Jun 2018
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

Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Not yet recruitingPhase 4
Clinical Evaluation of Visual Performance, Spectacle Independence, and Patient Satisfaction With TECNIS PureSee Mini-Monovision and TECNIS PureSee-TECNIS Odyssey Mix-Match
Presbyopia Correction, Presbyopia
Active, not recruiting
Presbyopic Wear Experience With Multifocal Lenses Compared to Single Vision Lenses and Reading Glasses
Presbyopia Correction, Presbyopia
Not yet recruitingObservational study
Night Driving After Trifocal Versus Monofocal IOL Implantation
Cataract, Presbyopia Correction
RecruitingObservational study
Luminous Efficiency Function V(λ)' of Patients That Underwent Pseudophakic Presbyopic Corrections With EDOF IOLs
Presbyopia

All Presbyopia Correction trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation
ClinicalTrials.gov ID: NCT02147093
Acronym / sponsor ID: CR-5175
Conditions: Presbyopia Correction
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 1 May 2014 (actual)
Primary completion: 1 Aug 2014 (actual)
Study completion: 1 Aug 2014 (actual)
First posted: 26 May 2014 (estimated)
Results: Posted 20 Jul 2016

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control (sphere) /Test (multi-focal)	Other	Device: Test (multi-focal), Device: Control (Sphere)Subjects were first fitted with Control lens (sphere) and a pair of reading glasses for one week. Subjects were then fitted with the Test lens (multi-focal) for one week.
Test (sphere) /Control (multi-focal)	Other	Device: Test (multi-focal), Device: Control (Sphere)Subjects were first fitted with the Test lens (multi-focal) for one week. Subjects were then fitted with Control lens (sphere) and a pair of reading glasses for one week.

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age 45 years or more
Spectacle or soft contact lens wearer
Refraction: best sphere (corrected for back vertex distance) -6.00 Diopters (D) to +4.00 D; Astigmatism - 0.00 D to -0.75 D; Near addition for 40 cm; Medium Add: +1.50 D to +2.00 D; High Add: +2.25 D to +2.50 D
Best spectacle corrected visual acuity of 6/9 or better in each eye
Willingness to adhere to the instructions set forth in the clinical protocol

Key exclusion criteria (14 listed)

Systemic or ocular allergies which might interfere with contact lens wear
Systemic disease which might interfere with contact lens wear
Ocular disease which might interfere with contact lens wear (e.g. hypothesia, insufficient lacrimal secretion)
Use of medication which might interfere with contact lens wear
Active ocular infection

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
Test (multi-focal)Also: Clariti 1 Day, filcon II 3contact lens was to be worn a daily wear.	Device	Control (sphere) /Test (multi-focal), Test (sphere) /Control (multi-focal)
Control (Sphere)Also: filcon II 3contact lens was to be worn a daily wear with spectacles	Device	Control (sphere) /Test (multi-focal), Test (sphere) /Control (multi-focal)

Primary outcome

Distance LogMAR Visual Acuity
Time frame: 7 days post wear
Distance time controlled LogMAR (Logarithm of the Minimum Angle of Resolution) Visual Acuity was carried out binocularly, at 4m (meter) under 250 cd/m^2 and 2.5 cd/m^2 (candela per square meter) luminance. The test was presented under the two conditions; High luminance (250 cd/m^2) High Contrast (90%) \& Low Contrast (10%) and Low Luminance (2.5 cd/m^2) High Contrast (90%)
Near LogMAR Visual Acuity
Time frame: 7 days post wear
Near time controlled LogMAR Visual Acuity was carried out binocularly, at 4cm under 250 cd/m^2 and 50 cd/m^2 luminance. The test was presented on under the two conditions; High Luminance (250cd/m^2) High Contrast (90%) \& Low Contrast (10%) and Low Luminance (50cd/m^2) High Contrast (90%)

Results and safety

Results posted to the registry on 20 Jul 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
Control (Filcon II 3- Sphere) /Test (Filcon II 3-multi-focal)	20	20
Test (Filcon II 3-multi-focal) /Control (Filcon II 3- Sphere)	20	19

Primary outcome: Distance LogMAR Visual Acuity

Time frame: 7 days post wear. Mean (Standard Deviation). Unit: LogMAR

Measure	Control (Filcon II 3-sphere) n = 37	Test (Filcon II 3-multi-focal) n = 37
High Contrast-Distance-Standard High Luminance	-0.466 (0.9995)	-0.972 (1.0104)
Low Contrast-Distance-Standard High Luminance	-2.842 (1.6850)	-3.768 (1.8023)
High Contrast-Distance-Standard Low Luminance	-2.834 (1.0042)	-3.700 (0.8939)

Population analysed: All subjects that completed all study visits without a major protocol deviation.

Primary outcome: Near LogMAR Visual Acuity

Time frame: 7 days post wear. Mean (Standard Deviation). Unit: LogMAR

Measure	Control (Filcon II 3-sphere) n = 37	Test (Filcon II 3-multi-focal) n = 37
High Contrast-Near-Standard High Luminance	-1.455 (0.6309)	-2.545 (1.1240)
Low Contrast-Near-Standard High Luminance	-2.151 (1.0221)	-3.820 (1.4124)
High Contrast-Near-Standard Low Luminance	-1.878 (1.0546)	-3.441 (1.3941)

Population analysed: All subjects that completed all study visits without a major protocol deviation.

Adverse events

Time frame: Throughout duration of the study(approximately 4 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control (Filcon II 3-sphere)	0 of 40 (0%)	0 of 40 (0%)	Not reported
Test (Filcon II 3-multi-focal)	0 of 40 (0%)	0 of 40 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Presbyopia Correction

Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Not yet recruitingPhase 4
Clinical Evaluation of Visual Performance, Spectacle Independence, and Patient Satisfaction With TECNIS PureSee Mini-Monovision and TECNIS PureSee-TECNIS Odyssey Mix-Match
Presbyopia Correction, Presbyopia
Active, not recruiting
Presbyopic Wear Experience With Multifocal Lenses Compared to Single Vision Lenses and Reading Glasses
Presbyopia Correction, Presbyopia
Not yet recruitingObservational study
Night Driving After Trifocal Versus Monofocal IOL Implantation
Cataract, Presbyopia Correction
RecruitingObservational study
Luminous Efficiency Function V(λ)' of Patients That Underwent Pseudophakic Presbyopic Corrections With EDOF IOLs
Presbyopia

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 Test (multi-focal) in people with Presbyopia Correction, run by Johnson & Johnson Vision Care, 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 6 inclusion and 14 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 19 Jun 2018. 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 20 Jul 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?

Distance LogMAR Visual Acuity (time frame: 7 days post wear). 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 NCT02147093.

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 19 Jun 2018.