AstigmatismNCT04050605
Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear
A study testing somofilcon A toric contact lens and fanfilcon A toric contact lens in people with Astigmatism, run by CooperVision, Inc. at 1 site in Mexico.
Trial summary
The aim of this prospective study is to evaluate the clinical performance of habitual wearers of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Astigmatism
- What is being tested?
- somofilcon A toric contact lens and fanfilcon A toric contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 4 Jun 2019to 18 Oct 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Is between 18 and 40 years of age (inclusive)
- Has had a self-reported visual exam in the last two years
- Is an adapted soft toric contact lens wearer
- Has a contact lens spherical prescription between +6.00 to -8.00 (inclusive)
- Have no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.
- Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
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- Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
- Has clear corneas and no active ocular disease
- Has read, understood and signed the information consent letter.
- Patient contact lens refraction should fit within the available parameters of the study lenses.
- Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
- Is willing to comply with the visit schedule
Who cannot join
- Has a CL prescription outside the range of the available parameters of the study lenses.
- Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye.
- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
- Presence of clinically significant (grade 2-4) anterior segment abnormalities
- Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
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- Slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Pterygium, pinguecula, or corneal scars within the visual axis
- Neovascularization > 0.75 mm in from of the limbus
- Giant papillary conjunctivitis (GCP) worse than grade 1
- Anterior uveitis or iritis (past or present)
- Seborrheic eczema, Seborrheic conjunctivitis
- History of corneal ulcers or fungal infections
- Poor personal hygiene
- Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- Has aphakia, keratoconus or a highly irregular cornea.
- Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this prospective study is to evaluate the clinical performance of habitual wearers of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear.
Read the detailed description
The aim of this prospective study is to evaluate the clinical performance of habitual wearers of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear.
This is a prospective, subject masked; bilateral, 1-month refit study comparing the fitting characteristics of Clariti Toric silicone hydrogel lenses, (somofilcon A); against Avaira Vitality silicone hydrogel Toric lenses (fanfilcon A).
- Conditions
- Astigmatism
- Being tested
- somofilcon A toric contact lens, fanfilcon A toric contact lens
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somofilcon A toric contact lensDevice
Also called Habitual lens
Contact Lens
fanfilcon A toric contact lensDevice
Also called Test Lens
Contact Lens
| Study group | Role | What they receive |
|---|---|---|
| somofilcon A toric (habitual), then fanfilcon toric (test) | Experimental | Participants are habitual wearers of somofilcon A toric lens and refitted with fanfilcon A toric lens. Receives: Device: somofilcon A toric contact lens; Device: fanfilcon A toric contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Centration - Somofilcon A Toric (Habitual) Lens
Lens Centration assessed using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Measured: Baseline
Lens Centration - Somofilcon A Toric (Habitual) Lens
Lens Centration (using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Measured: 4 weeks
Lens Centration - Fanfilcon A Toric Lens
Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Measured: Baseline
Lens Centration - Fanfilcon A Toric Lens
Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Measured: 2-weeks
Lens Centration - Fanfilcon A Toric Lens
Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Measured: 4-weeks
Corneal Coverage - Somofilcon A Toric (Habitual ) Lens
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Measured: Baseline
Corneal Coverage - Somofilcon A Toric (Habitual ) Lens
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Measured: 4-weeks
Corneal Coverage - Fanfilcon A Toric Lens
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Measured: Baseline
Corneal Coverage - Fanfilcon A Toric Lens
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Measured: 2-weeks
Corneal Coverage - Fanfilcon A Toric Lens
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Measured: 4-weeks
Post-Blink Movement - Somofilcon A Toric (Habitual) Lens
Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)
Measured: Baseline
Post-Blink Movement - Somofilcon A Toric (Habitual) Lens
Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Measured: 4-weeks
Post-Blink Movement - Fanfilcon A Toric Lens
Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Measured: Baseline
Post-Blink Movement - Fanfilcon A Toric Lens
Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Measured: 2-weeks
Post-Blink Movement - Fanfilcon A Toric Lens
Post-Blink movement (0-4 Scale,0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Measured: 4-weeks
Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens
Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Measured: Baseline
Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens
Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Measured: 4-weeks
Overall Lens Fit Acceptance - Fanfilcon A Toric Lens
Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Measured: Baseline
Overall Lens Fit Acceptance - Fanfilcon A Toric Lens
Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Measured: 2-weeks
Overall Lens Fit Acceptance - Fanfilcon A Toric Lens
Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Measured: 4-weeks
Secondary outcomes (6)
Average Daily Wearing Time - Somofilcon A Toric (Habitual) Lens
Average Daily Wearing Time for somofilcon A toric (habitual) lens measured by hours/day.
Measured: 4 weeks
Average Daily Wearing Time - Fanfilcon A Toric Lens
Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.
Measured: 2 weeks
Average Daily Wearing Time - Fanfilcon A Toric Lens
Average Daily Wearing Time for fanfilcon A toric lens measured by hours/day.
Measured: 4 weeks
Average Comfortable Wearing Time - Somofilcon A Toric (Habitual) Lens
Average Comfortable Wearing Time - somofilcon A toric (habitual) lens measured by hours/day
Measured: 4 weeks
Average Comfortable Wearing Time - Fanfilcon A Toric Lens
Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.
Measured: 2 weeks
Average Comfortable Wearing Time - Fanfilcon A Toric Lens
Average comfortable Wearing Time for fanfilcon A toric lens measured by hours/day.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start4 Jun 2019
- Primary completion16 Aug 2019
- Study completion18 Oct 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 AstigmatismStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- First pair of study lenses (habitual lenses - somofilcon A toric) will be dispensed and worn for 4-weeks of daily wear, then second pair of lenses (test lenses - fanfilcon A toric) will be dispensed and worn for 4-weeks for daily wear.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruben Velázquez Guerrero, MSc., FIACLE, Principal investigator, School of Optometry, National Autonomous University (UNAM), Mexico City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050605
- Sponsor's protocol ID
- EX-MKTG-102
- Status last verified
- Sep 2020
- First submitted
- 7 Aug 2019
- Last updated
- 9 Sep 2020
- 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 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refitting Somofilcon A Toric Contact Lens Wearers Into Fanfilcon A Toric Lenses for 4-weeks of Wear
- ClinicalTrials.gov ID
- NCT04050605
- Acronym / sponsor ID
- EX-MKTG-102
- Conditions
- Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 18 Oct 2019 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Posted 28 Aug 2020
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 prospective study is to evaluate the clinical performance of habitual wearers of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear.
Detailed description
The aim of this prospective study is to evaluate the clinical performance of habitual wearers of Clariti Toric lenses after a refit with Avaira Vitality Toric lenses for 1-month of daily wear.
This is a prospective, subject masked; bilateral, 1-month refit study comparing the fitting characteristics of Clariti Toric silicone hydrogel lenses, (somofilcon A); against Avaira Vitality silicone hydrogel Toric lenses (fanfilcon A).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- First pair of study lenses (habitual lenses - somofilcon A toric) will be dispensed and worn for 4-weeks of daily wear, then second pair of lenses (test lenses - fanfilcon A toric) will be dispensed and worn for 4-weeks for daily wear.
| Arm | Type | Receives |
|---|---|---|
| somofilcon A toric (habitual), then fanfilcon toric (test) | Experimental | Device: somofilcon A toric contact lens, Device: fanfilcon A toric contact lensParticipants are habitual wearers of somofilcon A toric lens and refitted with fanfilcon A toric lens. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Is between 18 and 40 years of age (inclusive)
- Has had a self-reported visual exam in the last two years
- Is an adapted soft toric contact lens wearer
- Has a contact lens spherical prescription between +6.00 to -8.00 (inclusive)
- Have no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.
Key exclusion criteria (20 listed)
- Has a CL prescription outside the range of the available parameters of the study lenses.
- Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye.
- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
- Presence of clinically significant (grade 2-4) anterior segment abnormalities
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 toric contact lensAlso: Habitual lensContact Lens | Device | somofilcon A toric (habitual), then fanfilcon toric (test) |
| fanfilcon A toric contact lensAlso: Test LensContact Lens | Device | somofilcon A toric (habitual), then fanfilcon toric (test) |
Primary outcome
Lens Centration - Somofilcon A Toric (Habitual) Lens
Time frame: Baseline
Lens Centration assessed using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Centration - Somofilcon A Toric (Habitual) Lens
Time frame: 4 weeks
Lens Centration (using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Centration - Fanfilcon A Toric Lens
Time frame: Baseline
Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Centration - Fanfilcon A Toric Lens
Time frame: 2-weeks
Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Centration - Fanfilcon A Toric Lens
Time frame: 4-weeks
Lens Centration using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Corneal Coverage - Somofilcon A Toric (Habitual ) Lens
Time frame: Baseline
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Corneal Coverage - Somofilcon A Toric (Habitual ) Lens
Time frame: 4-weeks
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Corneal Coverage - Fanfilcon A Toric Lens
Time frame: Baseline
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Corneal Coverage - Fanfilcon A Toric Lens
Time frame: 2-weeks
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Corneal Coverage - Fanfilcon A Toric Lens
Time frame: 4-weeks
Corneal Coverage (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Post-Blink Movement - Somofilcon A Toric (Habitual) Lens
Time frame: Baseline
Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)
Post-Blink Movement - Somofilcon A Toric (Habitual) Lens
Time frame: 4-weeks
Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Post-Blink Movement - Fanfilcon A Toric Lens
Time frame: Baseline
Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Post-Blink Movement - Fanfilcon A Toric Lens
Time frame: 2-weeks
Post-Blink movement (0-4 Scale, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Post-Blink Movement - Fanfilcon A Toric Lens
Time frame: 4-weeks
Post-Blink movement (0-4 Scale,0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens
Time frame: Baseline
Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Overall Lens Fit Acceptance - Somofilcon A Toric (Habitual) Lens
Time frame: 4-weeks
Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Overall Lens Fit Acceptance - Fanfilcon A Toric Lens
Time frame: Baseline
Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Overall Lens Fit Acceptance - Fanfilcon A Toric Lens
Time frame: 2-weeks
Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
Overall Lens Fit Acceptance - Fanfilcon A Toric Lens
Time frame: 4-weeks
Overall fit acceptance - using a 0 - 4 scale (where 0 = should not be worn, 1 = borderline but unacceptable, 2 = min. acceptable, early review, 3 = not perfect but OK to dispense, and 4 = perfect).
6 secondary outcomes
Average Daily Wearing Time - Somofilcon A Toric (Habitual) Lens
Time frame: 4 weeks
Average Daily Wearing Time - Fanfilcon A Toric Lens
Time frame: 2 weeks
Average Daily Wearing Time - Fanfilcon A Toric Lens
Time frame: 4 weeks
Average Comfortable Wearing Time - Somofilcon A Toric (Habitual) Lens
Time frame: 4 weeks
Average Comfortable Wearing Time - Fanfilcon A Toric Lens
Time frame: 2 weeks
Average Comfortable Wearing Time - Fanfilcon A Toric Lens
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- 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.
Ruben Velázquez Guerrero, MSc., FIACLE principal investigator
School of Optometry, National Autonomous University (UNAM), Mexico City
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 toric contact lens and fanfilcon A toric contact lens in people with Astigmatism, run by CooperVision, Inc. at 1 site in Mexico.
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 20 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 9 Sep 2020. 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 Mexico. 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 28 Aug 2020). 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?
Lens Centration - Somofilcon A Toric (Habitual) Lens (time frame: Baseline). The study lists 20 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 9 Sep 2020.