Refractive ErrorNCT03095027
Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear
A study testing FID122819 contact lenses and Stenfilcon A contact lenses in people with Refractive Error, run by Alcon Research at 3 sites in United States.
Trial summary
The purpose of this study is to compare the visual acuity of an investigational silicone hydrogel to a commercially available silicone hydrogel in contact lens wearers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractive Error
- What is being tested?
- FID122819 contact lenses and Stenfilcon A contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Apr 2017to 15 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and sign an IRB-approved Informed Consent Form;
- Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months:
- Manifest cylinder of ≤ 0.75 diopter (D) in each eye;
- Best corrected visual acuity (BCVA) of 20/25 or better in each eye;
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Any anterior segment infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
- History of refractive surgery or plan to have refractive surgery during the study;
- Ocular or intraocular surgery within the previous 12 months or planned during the study;
- Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;
- Any previous or current wear of MYDAY;
Show all 10Show fewer
- Habitually wearing monovision or multifocal lenses during the last 3 months;
- Routinely sleeping in lenses for at least 1 night per week over the last 3 months prior to enrollment;
- Any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear;
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Alcon Investigative Site
Johns Creek, Georgia, 30097
Alcon Investigative Site
Longwood, Florida, 32779
Alcon Investigative Site
Maitland, Florida, 32751
About this study
The purpose of this study is to compare the visual acuity of an investigational silicone hydrogel to a commercially available silicone hydrogel in contact lens wearers.
- Conditions
- Refractive Error
- Being tested
- FID122819 contact lenses, Stenfilcon A contact lenses
- Keywords
- contact lens, silicone hydrogel, daily disposable, visual acuity
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FID122819 contact lensesDevice
Also called DDT2, Verofilcon A
Investigational spherical silicone hydrogel contact lenses for daily disposable wear
Stenfilcon A contact lensesDevice
Also called MyDay®
Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
| Study group | Role | What they receive |
|---|---|---|
| FID122819, then stenfilcon A | Other | FID122819 contact lenses worn first, followed by stenfilcon A contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week Receives: Device: FID122819 contact lenses; Device: Stenfilcon A contact lenses |
| Stenfilcon A, then FID122819 | Other | Stenfilcon A contact lenses worn first, followed by FID122819 contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week Receives: Device: FID122819 contact lenses; Device: Stenfilcon A contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity (VA)
VA was assessed and collected using a Snellen chart. Conversion to logMAR (logarithm of the minimum angle of resolution) was performed. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. Both eyes contributed to the analysis.
Measured: Baseline/Dispense (Day 1), Week 1, each product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start19 Apr 2017
- Primary completion15 May 2017
- Study completion15 May 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 Refractive ErrorStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Clinical Manager, Trial Management Operations, Study director, Alcon, A Novartis Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095027
- Sponsor's protocol ID
- CLE383-C003
- Status last verified
- Jan 2019
- First submitted
- 23 Mar 2017
- Last updated
- 4 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear
- ClinicalTrials.gov ID
- NCT03095027
- Acronym / sponsor ID
- CLE383-C003
- Conditions
- Refractive Error
- Keywords
- contact lens, silicone hydrogel, daily disposable, visual acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 15 May 2017 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Posted 4 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the visual acuity of an investigational silicone hydrogel to a commercially available silicone hydrogel in contact lens wearers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FID122819, then stenfilcon A | Other | Device: FID122819 contact lenses, Device: Stenfilcon A contact lensesFID122819 contact lenses worn first, followed by stenfilcon A contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week |
| Stenfilcon A, then FID122819 | Other | Device: FID122819 contact lenses, Device: Stenfilcon A contact lensesStenfilcon A contact lenses worn first, followed by FID122819 contact lenses, as randomized. Each product worn in both eyes in a daily disposable mode for at least 8 hours per day, 5 days per week, for 1 week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to understand and sign an IRB-approved Informed Consent Form;
- Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months:
- Manifest cylinder of ≤ 0.75 diopter (D) in each eye;
- Best corrected visual acuity (BCVA) of 20/25 or better in each eye;
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (10 listed)
- Any anterior segment infection, inflammation, abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator;
- Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator;
- History of refractive surgery or plan to have refractive surgery during the study;
- Ocular or intraocular surgery within the previous 12 months or planned during the study;
- Current or history of pathologically dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens 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 |
|---|---|---|
| FID122819 contact lensesAlso: DDT2, Verofilcon AInvestigational spherical silicone hydrogel contact lenses for daily disposable wear | Device | FID122819, then stenfilcon A, Stenfilcon A, then FID122819 |
| Stenfilcon A contact lensesAlso: MyDay®Commercially available spherical silicone hydrogel contact lenses for daily disposable wear | Device | FID122819, then stenfilcon A, Stenfilcon A, then FID122819 |
Primary outcome
Visual Acuity (VA)
Time frame: Baseline/Dispense (Day 1), Week 1, each product
VA was assessed and collected using a Snellen chart. Conversion to logMAR (logarithm of the minimum angle of resolution) was performed. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity, with a negative value denoting better than 20/20 visual acuity. Both eyes contributed to the analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- 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.
Sr. Clinical Manager, Trial Management Operations study director
Alcon, A Novartis Division
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FID122819 contact lenses and Stenfilcon A contact lenses in people with Refractive Error, run by Alcon Research at 3 sites in United States.
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 5 inclusion and 10 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 4 Feb 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?
Visual Acuity (VA) (time frame: Baseline/Dispense (Day 1), Week 1, each product). 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 4 Feb 2019.