PresbyopiaNCT03519919
Somofilcon A 1-Day Multifocal Study - Real World Subjective Acceptance Study
A study testing somofilcon A multifocal lens in people with Presbyopia, run by CooperVision, Inc. at 1 site in Canada.
Trial summary
The objective of the study is to evaluate the performance of somofilcon A 1 day multifocal when worn on a daily disposable wear modality over a period of up to 3 weeks. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Presbyopia
- What is being tested?
- somofilcon A multifocal lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- 21 Aug 2017to 15 Feb 2019
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Has had a self-reported oculo-visual examination in the last two years.
- Currently wears multifocal soft contact lenses, and have worn multifocal contact lenses for at least one month;
- Presently wears lenses for minimum wear 4 days/week and 10 hours/day
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- Participant has an anticipated ability to wear test lenses for minimum 5 days/week and 10 hours/day.
- Can be fit with the available test contact lens power range to achieve satisfactory vision i.e. 0.18 logMar (20/30) binocular distance acuity with the test lenses.
- Current refraction indicates a reading addition of +1.50 or higher
- Uses a digital device (computer/laptop/tablet etc.) for at least 5hrs/day
- Spends 10 hrs or more indoors at least 5 days/week
- Possesses a smartphone and is willing to download the MetricWire app to receive
Who cannot join
- Is presently wearing Clariti 1 day multifocal lenses
- Has astigmatism greater than -0.75 DCyl as determined with subjective refraction
- Is participating in any concurrent clinical or research study;
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
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- Has known sensitivity to fluorescein dye or products to be used in the study;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
- Is aphakic;
- Has undergone refractive error surgery;
- Is an employee of the Centre for Contact Lens Research
Trial locations and contacts
1 site in 1 country.
Canada1 site
Center for Contact Lens Research, University of Waterloo
Waterloo, Ontario, N2L 3G1
About this study
Official title: Clariti 1-Day Multifocal Study - 'Real World' Subjective Acceptance Study (HARP)
The objective of the study is to evaluate the performance of somofilcon A 1 day multifocal when worn on a daily disposable wear modality over a period of up to 3 weeks.
- Conditions
- Presbyopia
- Being tested
- somofilcon A multifocal lens
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somofilcon A multifocal lensDevice
Also called clarifi multifocal lens
contact lens
| Study group | Role | What they receive |
|---|---|---|
| Somofilcon A multifocal lens | Experimental | Habitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. Receives: Device: somofilcon A multifocal lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vision Clarity During the Day - Distance Vision
Subjective expectation -Vision clarity during the day - distance vision was measured from three subjective expectation responses completed at the office. The responses were assigned numbers as below:
Fell short of expectations = 1 Met my expectations = 2 Exceeded my expectations = 3
Measured: Baseline
Vision Clarity During the Day - Distance Vision
Subjective expectation - Vision clarity during the day - distance vision was measured from three subjective expectation responses completed at the office. The responses were assigned numbers as below:
Fell short of expectations = 1 Met my expectations = 2 Exceeded my expectations = 3
Measured: 3 weeks
Secondary outcomes (30)
Number of Participants With Lens Centration
Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (>=0.5mm))
Measured: Baseline
Number of Participants With Lens Centration
Lens centration on the cornea (Optimum, Acceptable decentration, Unacceptable decentration (>=0.5mm))
Measured: 3 weeks
Visual Acuity
Distance visual acuity (logMAR)
Measured: Baseline
Visual Acuity
Distance visual acuity (logMAR)
Measured: 3 weeks
Post-blink Lens Movement
Movement of lens on eye after blink was graded on a 5-point Likert scale (0-4, 1 steps) as follows: 0 - insufficient, 1 - minimal but acceptable, 2 - optimal, 3 - moderate but acceptable, and 4 - excessive unacceptable movement.
Measured: Baseline
Post-blink Lens Movement
Movement of lens on eye after blink was graded on a 5-point scale (0-4, 1 steps) as follows: 0 - insufficient, 1 - minimal but acceptable, 2 - optimal, 3 - moderate but acceptable , and 4 - excessive unacceptable.
Measured: 3 weeks
Corneal Staining
Corneal staining will be assessed for extent (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentation for following regions: Temporal, Superior, Nasal, Inferior and Central.
Measured: Baseline
Corneal Staining
Corneal staining will be assessed for extent (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentation for following regions: Temporal, Superior, Nasal, Inferior and Central.
Measured: 3 weeks
Conjunctival Staining
Conjunctival staining will be assessed using CORE integer scale (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentation for following regions: Temporal, Superior, Nasal, Inferior.
Measured: Baseline
Conjunctival Staining
Conjunctival staining will be assessed using CORE integer scale (0-100) with 0 indicating no staining/indentation and 100 indicating deep confluent staining or severe indentationfor following regions: Temporal, Superior, Nasal, Inferior.
Measured: 3 weeks
Bulbar Hyperemia
Grading hyperemia of bulbar conjunctiva on a scale ranged from 0-4 and in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.
Measured: Baseline
Bulbar Hyperemia
Grading hyperemia of bulbar conjunctiva on a scale ranged from 0-4 and in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia.
Measured: 3 weeks
Subjective Vision Satisfaction - Driving at Night
Subjective satisfaction of distance vision while driving at night responses for habitual lens (1= fell short of expectation, 2 = met expectation, 3= exceed expectation)
Measured: Baseline
Subjective Vision Satisfaction - Driving at Night
Subjective satisfaction of distance vision while driving at night responses for somofilcon A multifocal lens (1= fell short of expectation, 2 = met expectation, 3= exceed expectation)
Measured: 3 weeks
Subjective Vision Satisfaction - Long Intermediate Vision
Subjective satisfaction of long intermediate vision while using desktop computer for habitual lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)
Measured: Baseline
Subjective Vision Satisfaction - Long Intermediate Vision
Subjective satisfaction of long intermediate vision while using desktop computer for somofilcon A multifocal lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)
Measured: 3 weeks
Subjective Vision Satisfaction - Short Intermediate Tasks
Subjective satisfaction of short/intermediate vision while using laptop/tablet for habitual lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)
Measured: Baseline
Subjective Vision Satisfaction - Short Intermediate Tasks
Subjective satisfaction of short/intermediate vision while using laptop/tablet for somofilcon A multifocal lens (1= fell short of expectation, 2= met expectation, 3= exceed expectation)
Measured: 3 weeks
Subjective Vision Satisfaction - Near Vision
Subjective satisfaction of near vision while reading on cell phone and hand-held materials for habitual lens (1 = fell short of expectation, 2 = met expectation, 3 = exceed expectation)
Measured: Baseline
Subjective Vision Satisfaction - Near Vision
Subjective satisfaction of near vision while reading on cell phone and hand-held materials for somofilcon A multifocal lens (1 = fell short of expectation, 2 = met expectation, 3 = exceed expectation)
Measured: 3 weeks
Ease of Insertion
Subjective rating how easy lens was inserted on eye for habitual lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)
Measured: Baseline
Ease of Insertion
Subjective rating how easy lens was inserted on eye for somofilcon A multifocal lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)
Measured: 3 weeks
Ease of Removal
Subjective rating for habitual lens on how easy lens was removed from eye (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)
Measured: Baseline
Ease of Removal
Subjective rating for somofilcon A multifocal lens on how easy lens was removed from eye (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)
Measured: 3 weeks
Overall Satisfaction With Speed of Changing Focus
Subjective rating for speed and ability to change focus between distances for habitual lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)
Measured: Baseline
Overall Satisfaction With Speed of Changing Focus
Subjective rating for speed and ability to change focus between distances for somofilcon A multifocal lens (1 = Fell short of expectation, 2 = Met expectation, 3 = Exceeded expectations)
Measured: 3 weeks
Overall Satisfaction Preference Between Study and Habitual Contact Lenses
Subjective satisfaction preference of contact lens between study and habitual contact lenses(Fell short of expectations, Met my expectation, Exceeded my expectation)
Measured: Baseline
Overall Satisfaction Preference Between Study and Habitual Contact Lenses
Subjective satisfaction preference between study and habitual contact lenses (Fell short of expectations, Met ,my expectations, Exceeded my expectations))
Measured: 3 weeks
Overall Comfort
Subjective rating of comfort for habitual lens and somofilcon A multifocal lens at 3 weeks (Prefer my own strongly, Prefer my own slightly, No preference, Prefer study lenses slightly, Prefer study lenses strongly)
Measured: 3 weeks
Overall Preference Between Study and Habitual Contact Lenses for Lifestyle
Preference of contact lens for the whole range of tasks (Prefer strongly, Prefer slightly, No preference, Prefer study lenses slightly, Prefer study lenses strongly)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start21 Aug 2017
- Primary completion22 Sep 2018
- Study completion15 Feb 2019
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 PresbyopiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519919
- Sponsor's protocol ID
- EX-MKTG-81
- Status last verified
- Dec 2019
- First submitted
- 1 May 2018
- Last updated
- 19 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clariti 1-Day Multifocal Study - 'Real World' Subjective Acceptance Study (HARP)
- ClinicalTrials.gov ID
- NCT03519919
- Acronym / sponsor ID
- EX-MKTG-81
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 22 Sep 2018 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Posted 10 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate the performance of somofilcon A 1 day multifocal when worn on a daily disposable wear modality over a period of up to 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Somofilcon A multifocal lens | Experimental | Device: somofilcon A multifocal lensHabitual wearers of multifocal contact lenses will be refit to somofilcon A multifocal lens and provide a subjective assessment. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Has had a self-reported oculo-visual examination in the last two years.
- Currently wears multifocal soft contact lenses, and have worn multifocal contact lenses for at least one month;
Key exclusion criteria (11 listed)
- Is presently wearing Clariti 1 day multifocal lenses
- Has astigmatism greater than -0.75 DCyl as determined with subjective refraction
- Is participating in any concurrent clinical or research study;
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
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 |
|---|---|---|
| somofilcon A multifocal lensAlso: clarifi multifocal lenscontact lens | Device | Somofilcon A multifocal lens |
Primary outcome
Vision Clarity During the Day - Distance Vision
Time frame: Baseline
Subjective expectation -Vision clarity during the day - distance vision was measured from three subjective expectation responses completed at the office. The responses were assigned numbers as below: Fell short of expectations = 1 Met my expectations = 2 Exceeded my expectations = 3
Vision Clarity During the Day - Distance Vision
Time frame: 3 weeks
Subjective expectation - Vision clarity during the day - distance vision was measured from three subjective expectation responses completed at the office. The responses were assigned numbers as below: Fell short of expectations = 1 Met my expectations = 2 Exceeded my expectations = 3
30 secondary outcomes
Number of Participants With Lens Centration
Time frame: Baseline
Number of Participants With Lens Centration
Time frame: 3 weeks
Visual Acuity
Time frame: Baseline
Visual Acuity
Time frame: 3 weeks
Post-blink Lens Movement
Time frame: Baseline
Post-blink Lens Movement
Time frame: 3 weeks
Corneal Staining
Time frame: Baseline
Corneal Staining
Time frame: 3 weeks
Conjunctival Staining
Time frame: Baseline
Conjunctival Staining
Time frame: 3 weeks
Bulbar Hyperemia
Time frame: Baseline
Bulbar Hyperemia
Time frame: 3 weeks
Subjective Vision Satisfaction - Driving at Night
Time frame: Baseline
Subjective Vision Satisfaction - Driving at Night
Time frame: 3 weeks
Subjective Vision Satisfaction - Long Intermediate Vision
Time frame: Baseline
Subjective Vision Satisfaction - Long Intermediate Vision
Time frame: 3 weeks
Subjective Vision Satisfaction - Short Intermediate Tasks
Time frame: Baseline
Subjective Vision Satisfaction - Short Intermediate Tasks
Time frame: 3 weeks
Subjective Vision Satisfaction - Near Vision
Time frame: Baseline
Subjective Vision Satisfaction - Near Vision
Time frame: 3 weeks
Ease of Insertion
Time frame: Baseline
Ease of Insertion
Time frame: 3 weeks
Ease of Removal
Time frame: Baseline
Ease of Removal
Time frame: 3 weeks
Overall Satisfaction With Speed of Changing Focus
Time frame: Baseline
Overall Satisfaction With Speed of Changing Focus
Time frame: 3 weeks
Overall Satisfaction Preference Between Study and Habitual Contact Lenses
Time frame: Baseline
Overall Satisfaction Preference Between Study and Habitual Contact Lenses
Time frame: 3 weeks
Overall Comfort
Time frame: 3 weeks
Overall Preference Between Study and Habitual Contact Lenses for Lifestyle
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- 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.
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 somofilcon A multifocal lens in people with Presbyopia, run by CooperVision, Inc. at 1 site in Canada.
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 12 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 19 Dec 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 Canada. 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 10 Dec 2019). 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?
Vision Clarity During the Day - Distance Vision (time frame: Baseline). 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?
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 Dec 2019.