Refractive ErrorsNCT03970512
Apioc Toric/Spherical Single Vision Contact Lens
A study testing Apioc-A and Apioc-S Contact Lenses in people with Refractive Errors, run by Lentechs, LLC at 2 sites in United States.
Trial summary
The Lentechs Apioc-S and Apioc-A contact lenses are made in an FDA-approved contact lens material indicated for single-vision and astigmatism. The novel lens design has a lenticular portion which is thicker than the optical portion of the lens. When applied to the eye, it is oriented in a superior position. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors
- What is being tested?
- Apioc-A and Apioc-S Contact Lenses
- Type of treatment
- Medical device
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 May 2019to 18 Mar 2021
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject must provide written informed consent.
- The subject must appear willing and able to adhere to the instructions set forth in this protocol.
- At least 18 years of age and no more than 35 years of age.
- ≤ 4.00 D of corneal astigmatism.
- ≤ 4.00 D of refractive astigmatism.
- Refractive error range +20.00 DS to -20.00 DS
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- Flat and steep keratometry readings within 40 to 50D.
- Clear, healthy corneas with no irregular astigmatism.
- Normal, healthy conjunctiva in both eyes.
- Free of active ocular disease. Refractive error is permitted.
- Be a current or former (within the last 12 months) contact lens wearer.
- Best-corrected near and distance visual acuity better than or equal to 20/25.
Who cannot join
- Irregular corneal astigmatism.
- Presbyopia
- Corneal scarring unless off line-of-site and well healed.
- Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear.
- Recent use of any ocular pharmaceutical treatments, including daily artificial tears, in the two weeks prior to the examination. Use of artificial tears less than 3 drops per week is permitted.
- Systemic disease that would interfere with contact lens wear.
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- Currently pregnant or lactating (by self-report).
- History of strabismus or eye movement disorder.
- Active allergies that may inhibit contact lens wear.
- Upper eyelid margin at or above the superior limbus.
- History of ocular or lid surgery.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Quinn Foster & Associates
Athens, Ohio, 45701
EyeCare Professionals of Powell
Powell, Ohio, 43065
About this study
Official title: 30 Day Fitting of a New Toric Contact Lens
The Lentechs Apioc-S and Apioc-A contact lenses are made in an FDA-approved contact lens material indicated for single-vision and astigmatism. The novel lens design has a lenticular portion which is thicker than the optical portion of the lens. When applied to the eye, it is oriented in a superior position. Unlike contact lenses currently on the market, this innovative design improves lens stability by preventing lens rotation, and may improve tear flow behind the lens.
- Conditions
- Refractive Errors
- Being tested
- Apioc-A and Apioc-S Contact Lenses
- Keywords
- contact lens, soft contact lens
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apioc-A and Apioc-S Contact LensesDevice
Appropriately fit, document and dispense a new spherical and toric contact lens design worn for up to 35 days.
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
LogMAR distance visual acuity
Measured: 30 days
Secondary outcomes (2)
Comfort
Contact Lens Dry Eye Questionnaire-8, scale range 0 minimum (better outcome) to 38 maximum (worse outcome).
Measured: 30 days
Rotational Stability of Apioc-A
Clockwise or counter-clockwise rotation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start31 May 2019
- Primary completion18 Mar 2021
- Study completion18 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lentechs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas G Quinn, OD, MS, FAAO, Principal investigator, Drs. Quinn, Foster & AssociatesJason R Miller, OD, MBA, Principal investigator, Eyecare Professionals of Powell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970512
- Sponsor's protocol ID
- LEN004
- Status last verified
- Jan 2022
- First submitted
- 29 May 2019
- Last updated
- 19 Jan 2022
- Results posted
- 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
- 30 Day Fitting of a New Toric Contact Lens
- ClinicalTrials.gov ID
- NCT03970512
- Acronym / sponsor ID
- LEN004
- Conditions
- Refractive Errors
- Keywords
- contact lens, soft contact lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Lentechs, LLCIndustry (pharma, biotech, devices)
- Study start
- 31 May 2019 (actual)
- Primary completion
- 18 Mar 2021 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 31 May 2019 (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.
The Lentechs Apioc-S and Apioc-A contact lenses are made in an FDA-approved contact lens material indicated for single-vision and astigmatism. The novel lens design has a lenticular portion which is thicker than the optical portion of the lens. When applied to the eye, it is oriented in a superior position. Unlike contact lenses currently on the market, this innovative design improves lens stability by preventing lens rotation, and may improve tear flow behind the lens.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- The subject must provide written informed consent.
- The subject must appear willing and able to adhere to the instructions set forth in this protocol.
- At least 18 years of age and no more than 35 years of age.
- ≤ 4.00 D of corneal astigmatism.
- ≤ 4.00 D of refractive astigmatism.
Key exclusion criteria (11 listed)
- Irregular corneal astigmatism.
- Presbyopia
- Corneal scarring unless off line-of-site and well healed.
- Pinguecula, pterygium, or other conjunctival thickness abnormalities that would interfere with soft contact lens wear.
- Recent use of any ocular pharmaceutical treatments, including daily artificial tears, in the two weeks prior to the examination. Use of artificial tears less than 3 drops per week is permitted.
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-A and Apioc-S Contact LensesAppropriately fit, document and dispense a new spherical and toric contact lens design worn for up to 35 days. | Device | – |
Primary outcome
Visual Acuity
Time frame: 30 days
LogMAR distance visual acuity
2 secondary outcomes
Comfort
Time frame: 30 days
Rotational Stability of Apioc-A
Time frame: 30 days
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.
Thomas G Quinn, OD, MS, FAAO principal investigator
Drs. Quinn, Foster & Associates
Jason R Miller, OD, MBA principal investigator
Eyecare Professionals of Powell
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apioc-A and Apioc-S Contact Lenses in people with Refractive Errors, run by Lentechs, LLC at 2 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 12 inclusion and 11 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 2 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?
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?
Visual Acuity (time frame: 30 days). 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.