MyopiaNCT06382064
Evaluation of Wear Experience With One Week Reusable Contact Lenses in Habitual Two Week Reusable Lens Wearers
A study testing Biweekly replacement contact lenses and One week replacement contact lenses in people with Myopia, run by Ohio State University at 1 site in United States.
Trial summary
This open-label study is of current Acuvue® Oasys® wearers (2 - week replacement, reusable lenses) who are satisfied with their current lenses. Subjects will be refit into one week reusable contact lenses and will wear lenses for approximately 2 weeks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- Biweekly replacement contact lenses and One week replacement contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2024to 9 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Ability to give informed consent
- Current Acuvue® Oasys® spherical lens wearer.
- Distance visual acuity of 20/25 or better with current contact lenses in each eye.
- Good general health defined by, medication use that has not changed within the last 30 days and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the Investigator.
- Willing to spend time for the study, which includes: attend three study visits and wear contact lenses on days between study visits.
Who cannot join
- Current or active ocular inflammation or infection as determined by the Investigator.
- Currently pregnant or lactating. (Participants will be asked to self-report these conditions).
- Systemic inflammatory disease (i.e. Diabetes, etc.) that could confound study results in the opinion of the 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 PRECISION7® Contact Lenses in Habitual Acuvue® Oasys® Lens Wearers
This open-label study is of current Acuvue® Oasys® wearers (2 - week replacement, reusable lenses) who are satisfied with their current lenses. Subjects will be refit into one week reusable contact lenses and will wear lenses for approximately 2 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience.
- Conditions
- Myopia
- Being tested
- Biweekly replacement contact lenses, One week replacement contact lenses
- Keywords
- Contact Lenses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biweekly replacement contact lensesDevice
Biweekly replacement reusable contact lenses.
One week replacement contact lensesDevice
One week replacement reusable contact lenses.
| Study group | Role | What they receive |
|---|---|---|
| Contact Lens Wear Experience | Experimental | Participants will be enrolled in the study for 4 weeks. Biweekly replacement contact lenses will be worn for the first 2 weeks. One-week replacement lenses worn for second 2 weeks. Receives: Device: Biweekly replacement contact lenses; Device: One week replacement contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Assessment of Lens Wear Experience
Subjective assessment of lens wear experience using a CLDEQ-8 survey (contact lens dry eye questionnaire). There are 8 questions about about the presence and intensity of symptoms when wearing contact lenses. When totaling the scores for each question, the lowest possible score=1 and the highest possible score=37. Higher scores result from more prevalent and intense symptoms.
Measured: After 2 weeks of wear in the 1-week replacement reusable lenses.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start16 Apr 2024
- Primary completion9 Dec 2024
- Study completion9 Dec 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
- Model description
- Subjects will be fit into Acuvue Oasys contact lenses at the first visit to wear for 2 weeks. Subjects will then be fit into PRECISION7 lenses at the second visit to wear for 2 weeks.
- Masking
- None (open label)
- Enrolment
- 71 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
- NCT06382064
- Sponsor's protocol ID
- 2024H0089
- Status last verified
- Oct 2025
- First submitted
- 19 Apr 2024
- Last updated
- 20 Oct 2025
- 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 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Wear Experience With PRECISION7® Contact Lenses in Habitual Acuvue® Oasys® Lens Wearers
- ClinicalTrials.gov ID
- NCT06382064
- Acronym / sponsor ID
- 2024H0089
- Conditions
- Myopia
- Keywords
- Contact Lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Posted 9 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label study is of current Acuvue® Oasys® wearers (2 - week replacement, reusable lenses) who are satisfied with their current lenses. Subjects will be refit into one week reusable contact lenses and will wear lenses for approximately 2 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects will be fit into Acuvue Oasys contact lenses at the first visit to wear for 2 weeks. Subjects will then be fit into PRECISION7 lenses at the second visit to wear for 2 weeks.
| Arm | Type | Receives |
|---|---|---|
| Contact Lens Wear Experience | Experimental | Device: Biweekly replacement contact lenses, Device: One week replacement contact lensesParticipants will be enrolled in the study for 4 weeks. Biweekly replacement contact lenses will be worn for the first 2 weeks. One-week replacement lenses worn for second 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years of age
- Ability to give informed consent
- Current Acuvue® Oasys® spherical lens wearer.
- Distance visual acuity of 20/25 or better with current contact lenses in each eye.
- Good general health defined by, medication use that has not changed within the last 30 days and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the Investigator.
Key exclusion criteria (3 listed)
- Current or active ocular inflammation or infection as determined by the Investigator.
- Currently pregnant or lactating. (Participants will be asked to self-report these conditions).
- Systemic inflammatory disease (i.e. Diabetes, etc.) that could confound study results in the opinion of the 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 |
|---|---|---|
| Biweekly replacement contact lensesBiweekly replacement reusable contact lenses. | Device | Contact Lens Wear Experience |
| One week replacement contact lensesOne week replacement reusable contact lenses. | Device | Contact Lens Wear Experience |
Primary outcome
Subjective Assessment of Lens Wear Experience
Time frame: After 2 weeks of wear in the 1-week replacement reusable lenses.
Subjective assessment of lens wear experience using a CLDEQ-8 survey (contact lens dry eye questionnaire). There are 8 questions about about the presence and intensity of symptoms when wearing contact lenses. When totaling the scores for each question, the lowest possible score=1 and the highest possible score=37. Higher scores result from more prevalent and intense symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biweekly replacement contact lenses and One week replacement contact lenses 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 6 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 20 Oct 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 9 Apr 2025). 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 Lens Wear Experience (time frame: After 2 weeks of wear in the 1-week replacement reusable lenses.). 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 20 Oct 2025.