Contact LensNCT04535310
Wear Experience With Daily Contact Lenses Over a Long Day
A study testing Precision1® Daily Disposable Contact Lens in people with Contact Lens, run by Ohio State University at 1 site in United States.
Trial summary
This study is evaluating the wear experience of a daily contact lens after 10, 12, 14, and 16 hours of lens wear. 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?
- Precision1® Daily Disposable Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2020to 31 Mar 2021
- 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 spherical contact lens wearer with longs days of lens wear.
- 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).
- Recent eye exam within the past year.
- Must have a working smart phone and be willing to download an app and/or receive and respond to texts.
- Ability to give informed consent.
- Willing to spend time for the study. Subjects will be required to attend three study visits, wear contact lenses on days between study visits, and must respond to push-notifications and/or texts on a smart phone for 5 days between visits 2 and 3.
Who cannot join
- No current ocular inflammation or infection as assessed by the study investigator.
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
Official title: Evaluation of Wear Experience With PRECISION1® Contact Lenses on Long Lens-wear Days
This study is evaluating the wear experience of a daily contact lens after 10, 12, 14, and 16 hours of lens wear.
- Conditions
- Contact Lens
- Being tested
- Precision1® Daily Disposable Contact Lens
- Keywords
- Daily Disposable Contact Lens, Spherical Contact Lens, Soft Contact Lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision1® Daily Disposable Contact LensDevice
Soft, spherical contact lens used to correct distance vision.
| Study group | Role | What they receive |
|---|---|---|
| Daily Disposable Contact Lens | Experimental | All subjects are fit into Precision1® contact lenses. Subjects are requested to wear the lenses for a total of two weeks. Receives: Device: Precision1® Daily Disposable Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Overall Comfort as Assessed Using the Visual Analog Scale (VAS)
Subjective overall comfort as assessed using the Visual Analog Scale (VAS), with a scale of 0 to 100 with 0 being poor and 100 being excellent.
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start13 Oct 2020
- Primary completion8 Dec 2020
- Study completion31 Mar 2021
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- 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
- NCT04535310
- Sponsor's protocol ID
- 2020H0324
- Status last verified
- Feb 2023
- First submitted
- 20 Aug 2020
- Last updated
- 8 Feb 2023
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Wear Experience With PRECISION1® Contact Lenses on Long Lens-wear Days
- ClinicalTrials.gov ID
- NCT04535310
- Acronym / sponsor ID
- 2020H0324
- Conditions
- Contact Lens
- Keywords
- Daily Disposable Contact Lens, Spherical Contact Lens, Soft Contact Lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 8 Dec 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 1 Sep 2020 (actual)
- Results
- Posted 8 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is evaluating the wear experience of a daily contact lens after 10, 12, 14, and 16 hours of lens wear.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daily Disposable Contact Lens | Experimental | Device: Precision1® Daily Disposable Contact LensAll subjects are fit into Precision1® contact lenses. Subjects are requested to wear the lenses for a total of two weeks. |
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 spherical contact lens wearer with longs days of lens wear.
- 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).
- Recent eye exam within the past year.
- Must have a working smart phone and be willing to download an app and/or receive and respond to texts.
Key exclusion criteria (1 listed)
- No current ocular inflammation or infection as assessed by the study investigator.
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 |
|---|---|---|
| Precision1® Daily Disposable Contact LensSoft, spherical contact lens used to correct distance vision. | Device | Daily Disposable Contact Lens |
Primary outcome
Subjective Overall Comfort as Assessed Using the Visual Analog Scale (VAS)
Time frame: Up to 14 days
Subjective overall comfort as assessed using the Visual Analog Scale (VAS), with a scale of 0 to 100 with 0 being poor and 100 being excellent.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Contact Lens
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Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
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Evaluation of Approved Contact Lenses (CR-6657)
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Using Contact Lenses and Spectacle Lenses as Myopia Interventions.
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Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
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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.
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 Precision1® Daily Disposable Contact Lens 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 1 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 8 Feb 2023. 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 8 Feb 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 Overall Comfort as Assessed Using the Visual Analog Scale (VAS) (time frame: Up to 14 days). 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 8 Feb 2023.