Astigmatism BilateralNCT05580575
Evaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric Contact Lenses
A study testing Daily disposable toric soft contact lens and Monthly replacement toric daily wear soft contact lens in people with Astigmatism Bilateral, run by Ohio State University at 3 sites in United States.
Trial summary
Comparison of wear experience with daily disposable and monthly replacement soft contact lenses in contact lens wearers who have astigmatism. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Astigmatism Bilateral
- What is being tested?
- Daily disposable toric soft contact lens and Monthly replacement toric daily wear soft contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Nov 2022to 9 Mar 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must be current soft lens wearers in both eyes.
- Subjects must have 20/25 or better distance visual acuity with current lenses (entering acuity).
- 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. Subjects will be required to attend two study visits and wear contact lenses on days between study visits.
- Either gender
- Any racial or ethnic origin
Who cannot join
- Participants cannot be pregnant or lactating.
- Participants cannot be current wearers of the study lenses
- No current ocular inflammation or infection as assessed by the study investigator
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Ohio State University College of Optometry
Columbus, Ohio, 43210
ProCare Vision Center
Granville, Ohio, 43023
Complete Eye Care of Medina
Medina, Minnesota, 55340
About this study
Official title: Evaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric
Comparison of wear experience with daily disposable and monthly replacement soft contact lenses in contact lens wearers who have astigmatism.
- Conditions
- Astigmatism Bilateral
- Being tested
- Daily disposable toric soft contact lens, Monthly replacement toric daily wear soft contact lens
- Keywords
- contact lenses, astigmatism
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily disposable toric soft contact lensDevice
Daily disposable toric soft contact lens
Monthly replacement toric daily wear soft contact lensDevice
Monthly replacement toric daily wear soft contact lens
| Study group | Role | What they receive |
|---|---|---|
| Daily disposable lens worn first, reusable lens worn second | Experimental | Subject will wear each contact lenses for 30 days during the day only. Receives: Device: Daily disposable toric soft contact lens; Device: Monthly replacement toric daily wear soft contact lens |
| Reusable lens worn first, daily disposable lens worn second | Experimental | Subject will wear each contact lenses for 30 days during the day only. Receives: Device: Daily disposable toric soft contact lens; Device: Monthly replacement toric daily wear soft contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale Survey of Overall Comfort
Visual analog scale survey of comfort from 0 to 100, with 0 anchored as "poor" and 100 as "excellent"
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Nov 2022
- Primary completion9 Mar 2023
- Study completion9 Mar 2023
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 Astigmatism BilateralStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05580575
- Sponsor's protocol ID
- 2022H0270
- Status last verified
- Apr 2024
- First submitted
- 12 Oct 2022
- Last updated
- 29 Apr 2024
- 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 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Wear Experience With Daily Disposable and Monthly Replacement Toric
- ClinicalTrials.gov ID
- NCT05580575
- Acronym / sponsor ID
- 2022H0270
- Conditions
- Astigmatism Bilateral
- Keywords
- contact lenses, astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 9 Mar 2023 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Posted 29 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of wear experience with daily disposable and monthly replacement soft contact lenses in contact lens wearers who have astigmatism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily disposable lens worn first, reusable lens worn second | Experimental | Device: Daily disposable toric soft contact lens, Device: Monthly replacement toric daily wear soft contact lensSubject will wear each contact lenses for 30 days during the day only. |
| Reusable lens worn first, daily disposable lens worn second | Experimental | Device: Daily disposable toric soft contact lens, Device: Monthly replacement toric daily wear soft contact lensSubject will wear each contact lenses for 30 days during the day only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must be current soft lens wearers in both eyes.
- Subjects must have 20/25 or better distance visual acuity with current lenses (entering acuity).
- 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. Subjects will be required to attend two study visits and wear contact lenses on days between study visits.
Key exclusion criteria (3 listed)
- Participants cannot be pregnant or lactating.
- Participants cannot be current wearers of the study lenses
- 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 |
|---|---|---|
| Daily disposable toric soft contact lensDaily disposable toric soft contact lens | Device | Daily disposable lens worn first, reusable lens worn second, Reusable lens worn first, daily disposable lens worn second |
| Monthly replacement toric daily wear soft contact lensMonthly replacement toric daily wear soft contact lens | Device | Daily disposable lens worn first, reusable lens worn second, Reusable lens worn first, daily disposable lens worn second |
Primary outcome
Visual Analog Scale Survey of Overall Comfort
Time frame: 1 month
Visual analog scale survey of comfort from 0 to 100, with 0 anchored as "poor" and 100 as "excellent"
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Astigmatism Bilateral
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily disposable toric soft contact lens and Monthly replacement toric daily wear soft contact lens in people with Astigmatism Bilateral, run by Ohio State University 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 7 inclusion and 3 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 29 Apr 2024. 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 29 Apr 2024). 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 Analog Scale Survey of Overall Comfort (time frame: 1 month). 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 29 Apr 2024.