AmetropiaNCT03688672
Apioc Contact Lens Feasibility
A study testing Apioc Contact Lens Design in people with Ametropia and Myopia, run by Lentechs, LLC at 1 site in United States.
Trial summary
This clinical trial will document the feasibility of the Apioc lens design by assessing which lens shape parameters yield successful on-eye-fit and movement of the Apioc contact lens design and evaluate the subjectively-reported comfort of the Apioc contact lens design. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Apioc Contact Lens Design
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Thirty subjects will be at least 40 years of age and no more than 60 years of age. Ten subjects will be at least 18 years of age and no more than 29 years of age. Ten subjects will be at least 30 years of age and no more than 39 years of age.
- The subject must have ≤ 1.50 D of corneal astigmatism.
- The subject should have clear, healthy corneas.
- The subject should have a normal, healthy conjunctiva in both eyes.
- The subject should be free of active ocular disease. Refractive error and presbyopia are permitted.
- The subject must provide written informed consent.
- The subject must appear willing and able to adhere to the instructions set forth in this protocol.
Who cannot join
- No irregular corneal astigmatism is permitted.
- No pterygia or corneal scarring that would interfere with contact lens wear.
- No pinguecula or other conjunctival thickness abnormalities are permitted that would interfere with contact lens wear.
- The subject should not be using any ocular pharmaceutical treatments, including artificial tears in the two weeks prior to the examination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Feasibility of Fitting of Apioc Contact Lenses in Adults
This clinical trial will document the feasibility of the Apioc lens design by assessing which lens shape parameters yield successful on-eye-fit and movement of the Apioc contact lens design and evaluate the subjectively-reported comfort of the Apioc contact lens design.
Read the detailed description
This is a one-site, non-dispensing clinical trial using the Apioc contact lens design. This soft contact lens study will determine the feasibility of this design by determining which parameters of the shape of the Apioc Contact Lens design will yield a successful fit across subjects. We will also determine the percentage of subjects who can be successfully fitted with the Apioc Contact Lens Design. Because the feasibility of the lens design may be dependent upon age, a total of 50 subjects (10 subjects each across 5 decades of life) will complete the study. The data will be collected in a single visit for most subjects. A few subjects may be asked to return for a second visit if additional contact lens parameters need to be ordered to achieve a successful fit. The key assessments for this study will be demonstration of feasibility of fit, documentation of movement in all gazes, including translation, and subjective reports of comfort. Subjects will only wear contact lenses while in the office.
- Conditions
- Ametropia, Myopia, Hyperopia, Astigmatism, Presbyopia
- Being tested
- Apioc Contact Lens Design
- Keywords
- contact lens, soft contact lens, feasibility
- Medical subject headings
- Refractive Errors, Myopia, Hyperopia, Astigmatism, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apioc Contact Lens DesignDevice
Novel soft contact lens design.
| Study group | Role | What they receive |
|---|---|---|
| Apioc Lens | Other | All subjects will wear the same, Apioc Contact Lens design. Receives: Device: Apioc Contact Lens Design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical Movement of Contact Lens in Downgaze
Vertical movement of the contact lens relative to the eye in downgaze in millimeters.
Measured: After 15 minutes of on-eye settling
Secondary outcomes (3)
Movement of contact lens with blink
Movement of contact lens in straight-ahead gaze with a blink in millimeters.
Measured: After 15 minutes of on-eye settling
Visual Acuity
logMAR visual acuity at 40 cm through the contact lens with distance correction in trial frame over the Apioc contact lens.
Measured: After 15 minutes of on-eye settling
Comfort questionnaire
Subjects will be asked to assess the comfort of each lens by marking an "X" on a line between 0 and 100.
Measured: After 15 minutes of on-eye settling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start1 Oct 2018
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmetropiaStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lentechs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Heidi Wagner, OD, MS, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688672
- Sponsor's protocol ID
- LEN001
- Status last verified
- Jan 2022
- First submitted
- 25 Sep 2018
- Last updated
- 19 Jan 2022
- Results posted
- No
- 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 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility of Fitting of Apioc Contact Lenses in Adults
- ClinicalTrials.gov ID
- NCT03688672
- Acronym / sponsor ID
- LEN001
- Conditions
- Ametropia, Myopia, Hyperopia, Astigmatism, Presbyopia
- Keywords
- contact lens, soft contact lens, feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Lentechs, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial will document the feasibility of the Apioc lens design by assessing which lens shape parameters yield successful on-eye-fit and movement of the Apioc contact lens design and evaluate the subjectively-reported comfort of the Apioc contact lens design.
Detailed description
This is a one-site, non-dispensing clinical trial using the Apioc contact lens design. This soft contact lens study will determine the feasibility of this design by determining which parameters of the shape of the Apioc Contact Lens design will yield a successful fit across subjects. We will also determine the percentage of subjects who can be successfully fitted with the Apioc Contact Lens Design. Because the feasibility of the lens design may be dependent upon age, a total of 50 subjects (10 subjects each across 5 decades of life) will complete the study. The data will be collected in a single visit for most subjects. A few subjects may be asked to return for a second visit if additional contact lens parameters need to be ordered to achieve a successful fit. The key assessments for this study will be demonstration of feasibility of fit, documentation of movement in all gazes, including translation, and subjective reports of comfort. Subjects will only wear contact lenses while in the office.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apioc Lens | Other | Device: Apioc Contact Lens DesignAll subjects will wear the same, Apioc Contact Lens design. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Thirty subjects will be at least 40 years of age and no more than 60 years of age. Ten subjects will be at least 18 years of age and no more than 29 years of age. Ten subjects will be at least 30 years of age and no more than 39 years of age.
- The subject must have ≤ 1.50 D of corneal astigmatism.
- The subject should have clear, healthy corneas.
- The subject should have a normal, healthy conjunctiva in both eyes.
- The subject should be free of active ocular disease. Refractive error and presbyopia are permitted.
Key exclusion criteria (4 listed)
- No irregular corneal astigmatism is permitted.
- No pterygia or corneal scarring that would interfere with contact lens wear.
- No pinguecula or other conjunctival thickness abnormalities are permitted that would interfere with contact lens wear.
- The subject should not be using any ocular pharmaceutical treatments, including artificial tears in the two weeks prior to the examination.
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 |
|---|---|---|
| Apioc Contact Lens DesignNovel soft contact lens design. | Device | Apioc Lens |
Primary outcome
Vertical Movement of Contact Lens in Downgaze
Time frame: After 15 minutes of on-eye settling
Vertical movement of the contact lens relative to the eye in downgaze in millimeters.
3 secondary outcomes
Movement of contact lens with blink
Time frame: After 15 minutes of on-eye settling
Visual Acuity
Time frame: After 15 minutes of on-eye settling
Comfort questionnaire
Time frame: After 15 minutes of on-eye settling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- 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.
Heidi Wagner, OD, MS principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apioc Contact Lens Design in people with Ametropia and Myopia, run by Lentechs, LLC 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 4 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 19 Jan 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Vertical Movement of Contact Lens in Downgaze (time frame: After 15 minutes of on-eye settling). 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 19 Jan 2022.