MyopiaNCT06172881
Novel Multifocal Soft Contact Lens Study
A study testing Investigational Contact Lens in people with Myopia, run by Ohio State University at 1 site in United States.
Trial summary
A single site, open label protocol will be used to evaluate the safety and quality of vision of a novel soft contact lens. Habitual contact lens wearers will be asked to come to the study site for one visit. Ocular health assessments and visual acuity will be completed with both the study lens and without. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Investigational Contact Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2023to 12 Jan 2024
- 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
- Ability to give informed consent
- Any gender
- Any racial or ethnic origin
- 18 - 40 years of age
- Distance visual acuity with best corrected visual acuity of 20/25 with each eye
- Habitual soft contact lens wearer with myopia
- 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 investigator).
Who cannot join
- Current or active ocular inflammation or infection as determined by the Investigator.
- Astigmatism > 0.75 D in either eye
- History of previous eye surgery
- Demonstration or history of corneal ectasia or keratoconus.
- 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
A single site, open label protocol will be used to evaluate the safety and quality of vision of a novel soft contact lens. Habitual contact lens wearers will be asked to come to the study site for one visit. Ocular health assessments and visual acuity will be completed with both the study lens and without.
- Conditions
- Myopia
- Being tested
- Investigational 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.
Investigational Contact LensDevice
A soft contact lens that will be worn only at the study visit.
| Study group | Role | What they receive |
|---|---|---|
| Distance Visual Acuity | Experimental | Visual acuity will be measured while participant's wear study lenses. Receives: Device: Investigational Contact Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance Visual Acuity
LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision.
Measured: 1 day (This is a single visit study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start14 Dec 2023
- Primary completion12 Jan 2024
- Study completion12 Jan 2024
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.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Myoptechs
- 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
- NCT06172881
- Sponsor's protocol ID
- 2023W0119
- Status last verified
- Apr 2024
- First submitted
- 29 Nov 2023
- Last updated
- 1 May 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 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Multifocal Soft Contact Lens Study
- ClinicalTrials.gov ID
- NCT06172881
- Acronym / sponsor ID
- 2023W0119
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Myoptechs
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 15 Dec 2023 (actual)
- Results
- Posted 1 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single site, open label protocol will be used to evaluate the safety and quality of vision of a novel soft contact lens. Habitual contact lens wearers will be asked to come to the study site for one visit. Ocular health assessments and visual acuity will be completed with both the study lens and without.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Distance Visual Acuity | Experimental | Device: Investigational Contact LensVisual acuity will be measured while participant's wear study lenses. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Ability to give informed consent
- Any gender
- Any racial or ethnic origin
- 18 - 40 years of age
- Distance visual acuity with best corrected visual acuity of 20/25 with each eye
Key exclusion criteria (5 listed)
- Current or active ocular inflammation or infection as determined by the Investigator.
- Astigmatism > 0.75 D in either eye
- History of previous eye surgery
- Demonstration or history of corneal ectasia or keratoconus.
- 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 |
|---|---|---|
| Investigational Contact LensA soft contact lens that will be worn only at the study visit. | Device | Distance Visual Acuity |
Primary outcome
Distance Visual Acuity
Time frame: 1 day (This is a single visit study)
LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- 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.
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 Investigational Contact Lens in people with Myopia, 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 5 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 1 May 2024. 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 1 May 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?
Distance Visual Acuity (time frame: 1 day (This is a single visit study)). 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 1 May 2024; AzTrials last refreshed its copy on 3 Nov 2026.