MyopiaNCT03974802
Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear
A study testing somofilcon A contact lens and fanfilcon A contact lens in people with Myopia, run by CooperVision, Inc. at 1 site in Mexico.
Trial summary
The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Myopia
- What is being tested?
- somofilcon A contact lens and fanfilcon A contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteMexico
- Study dates
- 14 May 2019to 28 Aug 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 contact lens wearer
- Has a contact lens spherical prescription between - 0.25 to - 8.00 (inclusive)
- Have no less than -0.75D of astigmatism 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 of ≥ 1.00D 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.
Mexico1 site
Optometry Clinic, National Autonomous University
Mexico City, 54090
About this study
The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses.
Read the detailed description
The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses for 4 weeks of daily wear.
- Conditions
- Myopia
- Being tested
- somofilcon A contact lens, fanfilcon A contact lens
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somofilcon A contact lensDevice
Also called clariti elite, Habitual lens
Contact Lens
fanfilcon A contact lensDevice
Also called Avaira Vitality, Test lens
Contact Lens
| Study group | Role | What they receive |
|---|---|---|
| somofilcon A (habitual) lens, then fanfilcon A (test) lens | Experimental | Participants are habitual wearers of somofilcon A lens and refitted with fanfilcon A lens. Receives: Device: somofilcon A contact lens; Device: fanfilcon A contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lens Centration for Somofilcon A (Habitual) Lens
Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Measured: Baseline
Lens Centration for Somofilcon A (Habitual) Lens
Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Measured: 4- weeks
Lens Centration for Fanfilcon A (Test) Lens
Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Measured: Baseline
Lens Centration for Fanfilcon A (Test) Lens
Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Measured: 2-weeks
Lens Centration for Fanfilcon A (Test) Lens
Lens Centration was measured using a 3-point scale(1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Measured: 4- weeks
Lens Corneal Coverage for Somofilcon A (Habitual) Lens
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Measured: Baseline
Lens Corneal Coverage for Somofilcon A (Habitual) Lens
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Measured: 4 -weeks
Lens Corneal Coverage for Fanfilcon A (Test) Lens
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Measured: Baseline
Lens Corneal Coverage for Fanfilcon A (Test) Lens
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Measured: 2-weeks
Lens Corneal Coverage for Fanfilcon A (Test) Lens
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Measured: 4-weeks
Percentage of Lens Tightness for Somofilcon A (Habitual) Lens
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Measured: Baseline
Percentage of Lens Tightness for Somofilcon A (Habitual) Lens
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Measured: 4-Weeks
Percentage of Lens Tightness for Fanfilcon A (Test) Lens
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Measured: Baseline
Percentage of Lens Tightness for Fanfilcon A (Test) Lens
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Measured: 2-Weeks
Percentage of Lens Tightness for Fanfilcon A (Test) Lens
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Measured: 4-Weeks
Post-Blink Movement for Somofilcon A (Habitual) Lens
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Measured: Baseline
Post-Blink Movement for Somofilcon A (Habitual) Lens
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Measured: 4-weeks
Post-Blink Movement for Fanfilcon A (Test) Lens
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Measured: Baseline
Post-Blink Movement for Fanfilcon A (Test) Lens
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Measured: 2-weeks
Post-Blink Movement for Fanfilcon A (Test) Lens
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Measured: 4-weeks
Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens
Overall fit acceptance was measured using a scale of 0-4 (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 for Somofilcon A (Habitual) Lens
Overall fit acceptance was measured using a scale of 0-4 (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 for Fanfilcon A (Test) Lens
Overall fit acceptance was measured using a scale of 0-4 (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 for Fanfilcon A (Test) Lens
Overall fit acceptance was measured using a scale of 0-4 (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 for Fanfilcon A (Test) Lens
Overall fit acceptance was measured using a scale of 0-4 (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 (Habitual) Lens
Average Daily Wearing Time for somofilcon A (Habitual) lens - measured by time hours/day
Measured: 4-weeks
Average Daily Wearing Time - Fanfilcon A (Test) Lens
Average daily wearing time for fanfilcon A (test) lens was measured in hours/day
Measured: 2-weeks
Average Daily Wearing Time - Fanfilcon A (Test) Lens
Average daily wearing time for fanfilcon A (test) lens was measured in hours/day
Measured: 4-weeks
Average Comfortable Wearing Time - Somofilcon A (Habitual) Lens
Average Comfortable Wearing Time - somofilcon A (habitual) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.
Measured: 4 weeks
Average Comfortable Wearing Time - Fanfilcon A (Test) Lens
Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.
Measured: 2 weeks
Average Comfortable Wearing Time - Fanfilcon A (Test) Lens
Average Comfortable Wearing Time - fanfilcon A (test) Lens measured in hours/day. Assessed using typical time of day when subject first experiences lens awareness or irritation.
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 posted5 Jun 2019
- Study start14 May 2019
- Primary completion24 Jul 2019
- Study completion28 Aug 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 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
- Not applicable
- Intervention model
- Single group
- Model description
- First pair of study lenses (habitual lenses) will be dispensed and worn for 4 weeks for daily wear, then second pair of lenses (test lenses) will be dispensed and worn for 4 weeks for daily wear.
- Masking
- None (open label)
- Enrolment
- 41 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
- NCT03974802
- Sponsor's protocol ID
- EX-MKTG-101
- Status last verified
- Aug 2020
- First submitted
- 3 Jun 2019
- Last updated
- 18 Aug 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 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refitting Somofilcon A Sphere Contact Lens Wearers Into Fanfilcon A Sphere Lenses for 4-Weeks of Wear
- ClinicalTrials.gov ID
- NCT03974802
- Acronym / sponsor ID
- EX-MKTG-101
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 May 2019 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Posted 18 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 subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses.
Detailed description
The aim of this subject-masked prospective study is to evaluate the clinical performance of habitual wearers of Clariti Elite sphere lenses after a refit with Avaira Vitality sphere lenses for 4 weeks of daily wear.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- First pair of study lenses (habitual lenses) will be dispensed and worn for 4 weeks for daily wear, then second pair of lenses (test lenses) will be dispensed and worn for 4 weeks for daily wear.
| Arm | Type | Receives |
|---|---|---|
| somofilcon A (habitual) lens, then fanfilcon A (test) lens | Experimental | Device: somofilcon A contact lens, Device: fanfilcon A contact lensParticipants are habitual wearers of somofilcon A lens and refitted with fanfilcon A 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 contact lens wearer
- Has a contact lens spherical prescription between - 0.25 to - 8.00 (inclusive)
- Have no less than -0.75D of astigmatism 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 of ≥ 1.00D 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 contact lensAlso: clariti elite, Habitual lensContact Lens | Device | somofilcon A (habitual) lens, then fanfilcon A (test) lens |
| fanfilcon A contact lensAlso: Avaira Vitality, Test lensContact Lens | Device | somofilcon A (habitual) lens, then fanfilcon A (test) lens |
Primary outcome
Lens Centration for Somofilcon A (Habitual) Lens
Time frame: Baseline
Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Centration for Somofilcon A (Habitual) Lens
Time frame: 4- weeks
Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Centration for Fanfilcon A (Test) Lens
Time frame: Baseline
Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Centration for Fanfilcon A (Test) Lens
Time frame: 2-weeks
Lens Centration was measured using a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Centration for Fanfilcon A (Test) Lens
Time frame: 4- weeks
Lens Centration was measured using a 3-point scale(1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).
Lens Corneal Coverage for Somofilcon A (Habitual) Lens
Time frame: Baseline
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Lens Corneal Coverage for Somofilcon A (Habitual) Lens
Time frame: 4 -weeks
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Lens Corneal Coverage for Fanfilcon A (Test) Lens
Time frame: Baseline
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Lens Corneal Coverage for Fanfilcon A (Test) Lens
Time frame: 2-weeks
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Lens Corneal Coverage for Fanfilcon A (Test) Lens
Time frame: 4-weeks
Lens Corneal Coverage was rated as either Yes or No (Yes = full corneal coverage all time / no= incomplete corneal coverage)
Percentage of Lens Tightness for Somofilcon A (Habitual) Lens
Time frame: Baseline
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Percentage of Lens Tightness for Somofilcon A (Habitual) Lens
Time frame: 4-Weeks
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Percentage of Lens Tightness for Fanfilcon A (Test) Lens
Time frame: Baseline
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Percentage of Lens Tightness for Fanfilcon A (Test) Lens
Time frame: 2-Weeks
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Percentage of Lens Tightness for Fanfilcon A (Test) Lens
Time frame: 4-Weeks
Lens Tightness: Push Up Test measured by 0% to 100% continuous scale (0%-falls from cornea without lid support, 50% = optimum, and 100% = no movement)
Post-Blink Movement for Somofilcon A (Habitual) Lens
Time frame: Baseline
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Post-Blink Movement for Somofilcon A (Habitual) Lens
Time frame: 4-weeks
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Post-Blink Movement for Fanfilcon A (Test) Lens
Time frame: Baseline
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Post-Blink Movement for Fanfilcon A (Test) Lens
Time frame: 2-weeks
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Post-Blink Movement for Fanfilcon A (Test) Lens
Time frame: 4-weeks
Post-Blink movement was measured on a scale 0-4 (0=Insufficient, unacceptable movement, 4 = Excessive, unacceptable movement)
Overall Lens Fit Acceptance for Somofilcon A (Habitual) Lens
Time frame: Baseline
Overall fit acceptance was measured using a scale of 0-4 (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 for Somofilcon A (Habitual) Lens
Time frame: 4-weeks
Overall fit acceptance was measured using a scale of 0-4 (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 for Fanfilcon A (Test) Lens
Time frame: Baseline
Overall fit acceptance was measured using a scale of 0-4 (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 for Fanfilcon A (Test) Lens
Time frame: 2-weeks
Overall fit acceptance was measured using a scale of 0-4 (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 for Fanfilcon A (Test) Lens
Time frame: 4-weeks
Overall fit acceptance was measured using a scale of 0-4 (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 (Habitual) Lens
Time frame: 4-weeks
Average Daily Wearing Time - Fanfilcon A (Test) Lens
Time frame: 2-weeks
Average Daily Wearing Time - Fanfilcon A (Test) Lens
Time frame: 4-weeks
Average Comfortable Wearing Time - Somofilcon A (Habitual) Lens
Time frame: 4 weeks
Average Comfortable Wearing Time - Fanfilcon A (Test) Lens
Time frame: 2 weeks
Average Comfortable Wearing Time - Fanfilcon A (Test) 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 18 Aug 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 contact lens and fanfilcon A contact lens in people with Myopia, 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 18 Aug 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 18 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 for Somofilcon A (Habitual) Lens (time frame: Baseline). The study lists 25 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 18 Aug 2020.