Astigmatism BilateralNCT06751225
Evaluation of Wear Experience With a Weekly Replacement Soft Contact Lens in Neophyte Lens Wearers With Astigmatism
A study testing One week replacement soft contact lenses in people with Astigmatism Bilateral, run by Ohio State University at 1 site in United States.
Trial summary
This open-label study is of adults with astigmatism who have never worn contact lenses. Subjects will be fit into a one week planned-replacement contact lenses and will wear lenses for approximately 3 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Astigmatism Bilateral
- What is being tested?
- One week replacement soft contact lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2025to 4 Nov 2025
- 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
- Subjects must be new to contact lenses and have astigmatism of -0.75 or greater (within the parameters available for the P7fA lenses)
- Subjects must have 20/20 or better best corrected visual 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 three study visits and wear contact lenses on days between study visits.
- Willing and able to wear contact lenses for at least 8 hours per day for 5 days per week during the study as daily wear.
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- Currently not using eye lubricating drops and willing to not use during study.
- Either gender and 18-40 years of age.
- Any racial or ethnic origin
Who cannot join
- Any active ocular inflammation or infection.
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
- Are presbyopic and require or habitually uses reading glasses for near work
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
- History of refractive surgery
- Meets the diagnosis of dry eye disease with OSDI screening score ≥13.
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- Known history of allergy or sensitivity to contact lens solutions and/or sodium fluorescein
- Is pregnant or lactating or planning a pregnancy during enrollment in the study
- Is participating in another clinical research study that includes invasive ocular tests
- An inability to perform contact lens application and removal after instruction.
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
This open-label study is of adults with astigmatism who have never worn contact lenses. Subjects will be fit into a one week planned-replacement contact lenses and will wear lenses for approximately 3 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience.
- Conditions
- Astigmatism Bilateral
- Being tested
- One week replacement soft contact lenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One week replacement soft contact lensesDevice
One week replacement soft contact lenses
| Study group | Role | What they receive |
|---|---|---|
| Contact Lens Wear Experience | Experimental | One week replacement soft contact lenses will be worn for 3 weeks. Receives: Device: One week replacement soft 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
VAS assessment of overall vision. (0-100 scale; 0=unacceptable 100=excellent)
Measured: After 3 weeks of lens wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start21 Jan 2025
- Primary completion4 Nov 2025
- Study completion4 Nov 2025
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
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects will be fit into the one week replacement soft contact lens to wear for 3 weeks.
- Masking
- None (open label)
- Enrolment
- 40 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751225
- Sponsor's protocol ID
- 2024H0379
- Status last verified
- May 2026
- First submitted
- 20 Dec 2024
- Last updated
- 4 Jun 2026
- 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Wear Experience With a Weekly Replacement Soft Contact Lens in Neophyte Lens Wearers With Astigmatism
- ClinicalTrials.gov ID
- NCT06751225
- Acronym / sponsor ID
- 2024H0379
- Conditions
- Astigmatism Bilateral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- 4 Nov 2025 (actual)
- Study completion
- 4 Nov 2025 (actual)
- First posted
- 27 Dec 2024 (actual)
- Results
- Posted 4 Jun 2026
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 adults with astigmatism who have never worn contact lenses. Subjects will be fit into a one week planned-replacement contact lenses and will wear lenses for approximately 3 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 the one week replacement soft contact lens to wear for 3 weeks.
| Arm | Type | Receives |
|---|---|---|
| Contact Lens Wear Experience | Experimental | Device: One week replacement soft contact lensesOne week replacement soft contact lenses will be worn for 3 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subjects must be new to contact lenses and have astigmatism of -0.75 or greater (within the parameters available for the P7fA lenses)
- Subjects must have 20/20 or better best corrected visual 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 three study visits and wear contact lenses on days between study visits.
Key exclusion criteria (10 listed)
- Any active ocular inflammation or infection.
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
- Are presbyopic and require or habitually uses reading glasses for near work
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
- History of refractive surgery
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 |
|---|---|---|
| One week replacement soft contact lensesOne week replacement soft contact lenses | Device | Contact Lens Wear Experience |
Primary outcome
Subjective Assessment of Lens Wear Experience
Time frame: After 3 weeks of lens wear
VAS assessment of overall vision. (0-100 scale; 0=unacceptable 100=excellent)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Astigmatism Bilateral
Active, not recruiting
Spectacle Prescribing in Early Childhood
Astigmatism Bilateral, Eyeglasses
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 One week replacement soft contact lenses in people with Astigmatism Bilateral, 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 9 inclusion and 10 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 4 Jun 2026. 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 4 Jun 2026). 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 3 weeks of lens wear). 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 4 Jun 2026.