Contact LensNCT05102383
Evaluation of Wear Experience With a Water Surface Daily Disposable Contact Lens
A study testing Comfilcon A Toric contact lenses and Verofilcon A for Astigmatism Daily Disposable contact lenses in people with Contact Lens, run by Ohio State University at 1 site in United States.
Trial summary
The purpose of this study is to assess the wear experience of existing wearers of a monthly replacement contact lens after they have been fit with a daily disposable contact lens that has water surface treatment. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Lens
- What is being tested?
- Comfilcon A Toric contact lenses and Verofilcon A for Astigmatism Daily Disposable contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 19 Apr 2022
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be a current wearer of Comfilcon A contact lenses
- Distance visual acuity of 20/25 or better with current contact lenses
- Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI)
- Ability to give informed consent
- Willing to spend time for the study, which includes attending three study visits and be willing to wear contact lenses on days between study visits.
- Either gender.
- Any racial or ethnic origin.
Who cannot join
- No current ocular inflammation or infection.
- Not currently pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Optometry
Columbus, Ohio, 43210
About this study
The purpose of this study is to assess the wear experience of existing wearers of a monthly replacement contact lens after they have been fit with a daily disposable contact lens that has water surface treatment.
- Conditions
- Contact Lens
- Being tested
- Comfilcon A Toric contact lenses, Verofilcon A for Astigmatism Daily Disposable contact lenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comfilcon A Toric contact lensesDevice
Monthly replacement contact lenses
Verofilcon A for Astigmatism Daily Disposable contact lensesDevice
Daily disposable contact lenses
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants have habitual Comfilcon A Toric lenses optimized for wear over 2 weeks. Then all participants are fit with the Verofilcon A study daily disposable lenses with water surface treatment for astigmatism. Receives: Device: Comfilcon A Toric contact lenses; Device: Verofilcon A for Astigmatism Daily Disposable contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Assessment of Overall Comfort With Verofilcon A Daily Disposable Lenses for Astigmatism
Participants will complete a Visual Analog Scale survey of overall comfort (0-100 Scale with 0 anchored with "Poor Comfort" and 100 anchored as "Excellent Comfort")
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 posted1 Nov 2021
- Study start15 Nov 2021
- Primary completion19 Apr 2022
- Study completion19 Apr 2022
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 Contact LensStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Fogt, Ohio State University
- Investigators
- Jennifer Fogt, OD MS, Principal investigator, The Ohio State University College of Optometry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102383
- Sponsor's protocol ID
- 2021H0305
- Status last verified
- Nov 2025
- First submitted
- 15 Oct 2021
- Last updated
- 25 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Wear Experience With a Water Surface Daily Disposable Contact Lens
- ClinicalTrials.gov ID
- NCT05102383
- Acronym / sponsor ID
- 2021H0305
- Conditions
- Contact Lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 19 Apr 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Posted 6 Dec 2023
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 assess the wear experience of existing wearers of a monthly replacement contact lens after they have been fit with a daily disposable contact lens that has water surface treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Device: Comfilcon A Toric contact lenses, Device: Verofilcon A for Astigmatism Daily Disposable contact lensesAll participants have habitual Comfilcon A Toric lenses optimized for wear over 2 weeks. Then all participants are fit with the Verofilcon A study daily disposable lenses with water surface treatment for astigmatism. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Must be a current wearer of Comfilcon A contact lenses
- Distance visual acuity of 20/25 or better with current contact lenses
- Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI)
- Ability to give informed consent
- Willing to spend time for the study, which includes attending three study visits and be willing to wear contact lenses on days between study visits.
Key exclusion criteria (2 listed)
- No current ocular inflammation or infection.
- Not currently pregnant or lactating
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 |
|---|---|---|
| Comfilcon A Toric contact lensesMonthly replacement contact lenses | Device | All participants |
| Verofilcon A for Astigmatism Daily Disposable contact lensesDaily disposable contact lenses | Device | All participants |
Primary outcome
Subjective Assessment of Overall Comfort With Verofilcon A Daily Disposable Lenses for Astigmatism
Time frame: 3 weeks
Participants will complete a Visual Analog Scale survey of overall comfort (0-100 Scale with 0 anchored with "Poor Comfort" and 100 anchored as "Excellent Comfort")
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Contact Lens
Active, not recruiting
P1 Toric Vs. Max 1day
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Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
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Active, not recruiting
Evaluation of Approved Contact Lenses (CR-6657)
Visual Acuity
Not yet recruiting
Using Contact Lenses and Spectacle Lenses as Myopia Interventions.
Myopia
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
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.
Jennifer Fogt, OD MS principal investigator
The Ohio State University College of Optometry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comfilcon A Toric contact lenses and Verofilcon A for Astigmatism Daily Disposable contact lenses in people with Contact Lens, run by Ohio State University at 1 site 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 7 inclusion and 2 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 25 Nov 2025. 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 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 6 Dec 2023). 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?
Subjective Assessment of Overall Comfort With Verofilcon A Daily Disposable Lenses for Astigmatism (time frame: 3 weeks). 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 25 Nov 2025.