PresbyopiaNCT04437732
Apioc Presbyopic Contact Lens
A study testing Apioc-P and Apioc-PT Contact Lens Design in people with Presbyopia and Refractive Errors, run by Lentechs, LLC at 2 sites in United States.
Trial summary
In this study, you will wear an invesetigational contact lens, Apioc-P or Apioc-PT, the way you wear your current contact lenses for approximately one month (no more than 35 days). Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia, Refractive Errors
- What is being tested?
- Apioc-P and Apioc-PT Contact Lens Design
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Nov 2019to 9 Jun 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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 40 years of age and no more than 70 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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- 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 and presbyopia are 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.
- 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 times per week is permitted.
- Systemic disease that would interfere with contact lens wear.
- Currently pregnant or lactating (by self-report).
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- History of strabismus or eye movement disorder, including exophoria at near that is 4D or greater than at far, and a receded near point of convergence break that is 6 cm or greater.
- 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 Trial Fitting of a New Bifocal Contact Lens
In this study, you will wear an invesetigational contact lens, Apioc-P or Apioc-PT, the way you wear your current contact lenses for approximately one month (no more than 35 days).
Read the detailed description
Apioc-P and Apioc-PT is an investigational contact lens, which means it has not been approved by the U.S. Food and Drug Administration (FDA), although the contact lens material, called Definitive 74, is already approved and marketed for contact lenses that are similar to Apioc-P and Apioc-PT. In this study, participants will wear an Apioc-P and Apioc-PT contact lens the way they wear their current contact lenses for approximately one month (no more than 35 days).
Participation in this study will include a minimum of four study visits. The first will last up to 90 minutes, the second will last up to 45 minutes, the third will last up to 45 minutes, and the final visit will be up to 90 minutes. If the lens does not appear to be fitting properly at the second visit, then another lens will be ordered for participants and they will be asked to return for an additional visit for up to 45 minutes. Up to 60 subjects will participate in this study.
- Conditions
- Presbyopia, Refractive Errors
- Being tested
- Apioc-P and Apioc-PT Contact Lens Design
- Keywords
- contact lens, soft contact lens
- Medical subject headings
- Presbyopia, Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apioc-P and Apioc-PT Contact Lens DesignDevice
Novel soft contact lens design
| Study group | Role | What they receive |
|---|---|---|
| Apioc Lens | Other | All subjects will wear either the Apioc-P or Apioc-PT contact lens design Receives: Device: Apioc-P and Apioc-PT Contact Lens Design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
LogMAR visual acuity
Measured: 30 days
Secondary outcomes (1)
Comfort
Contact Lens Dry Eye Questionnaire-8, scale range 0 minimum (better outcome) to 38 maximum (worse outcome).
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 posted18 Jun 2020
- Study start11 Nov 2019
- Primary completion9 Jun 2021
- Study completion9 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbyopiaStudies 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
- 49 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
- NCT04437732
- Sponsor's protocol ID
- LEN-002
- Status last verified
- Jan 2022
- First submitted
- 16 Jun 2020
- 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
- 30 Day Trial Fitting of a New Bifocal Contact Lens
- ClinicalTrials.gov ID
- NCT04437732
- Acronym / sponsor ID
- LEN-002
- Conditions
- Presbyopia, Refractive Errors
- Keywords
- contact lens, soft contact lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Lentechs, LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 18 Jun 2020 (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.
In this study, you will wear an invesetigational contact lens, Apioc-P or Apioc-PT, the way you wear your current contact lenses for approximately one month (no more than 35 days).
Detailed description
Apioc-P and Apioc-PT is an investigational contact lens, which means it has not been approved by the U.S. Food and Drug Administration (FDA), although the contact lens material, called Definitive 74, is already approved and marketed for contact lenses that are similar to Apioc-P and Apioc-PT. In this study, participants will wear an Apioc-P and Apioc-PT contact lens the way they wear their current contact lenses for approximately one month (no more than 35 days).
Participation in this study will include a minimum of four study visits. The first will last up to 90 minutes, the second will last up to 45 minutes, the third will last up to 45 minutes, and the final visit will be up to 90 minutes. If the lens does not appear to be fitting properly at the second visit, then another lens will be ordered for participants and they will be asked to return for an additional visit for up to 45 minutes. Up to 60 subjects will participate in this study.
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-P and Apioc-PT Contact Lens DesignAll subjects will wear either the Apioc-P or Apioc-PT contact lens design |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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 40 years of age and no more than 70 years of age.
- ≤ 4.00 D of corneal astigmatism.
- ≤ 4.00 D of refractive astigmatism.
Key exclusion criteria (10 listed)
- Irregular corneal astigmatism.
- 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 times per week is permitted.
- Systemic disease that would interfere with contact lens wear.
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-P and Apioc-PT Contact Lens DesignNovel soft contact lens design | Device | Apioc Lens |
Primary outcome
Visual Acuity
Time frame: 30 days
LogMAR visual acuity
1 secondary outcome
Comfort
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-P and Apioc-PT Contact Lens Design in people with Presbyopia and 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 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 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; AzTrials last refreshed its copy on 26 Oct 2026.