Contact Lens-Induced Corneal Disorder of Both Eyes (Diagnosis)NCT04031118
Corneal Oxygen Uptake With Apioc Contact Lenses
A study testing Apioc Contact Lens in people with Contact Lens-Induced Corneal Disorder of Both Eyes (Diagnosis), run by Lentechs, LLC at 1 site in United States.
Trial summary
The purpose of this research is to determine if a new investigational contact lens shape allows the eye to get more oxygen. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Lens-Induced Corneal Disorder of Both Eyes (Diagnosis)
- What is being tested?
- Apioc Contact Lens
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2019to 1 Nov 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provide informed consent.
- Appear willing and able to adhere to instructions set forth in the protocol.
- Be between the ages of 18 and 45.
- Be an experienced contact lens wearer.
- Be an eyecare clinician or clinician-in-training.
- Flat and steep keratometry readings within 40 to 50D.
Show all 10Show fewer
- Clear, healthy corneas with no irregular astigmatism.
- Normal, healthy conjunctiva in both eyes.
- Be able to provide corneal topography measurements.
- Be able to provide manifest refraction measurements.
Who cannot join
- Irregular corneal astigmatism.
- Use of topical or systemic antihistamines within the previous week.
- Use of topical ophthalmic drops within the previous two days.
- History of corneal surgery.
- Currently pregnant or lactating.
- Systemic disease that would interfere with contact lens wear.
- Previous diagnosis of dry eye syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research is to determine if a new investigational contact lens shape allows the eye to get more oxygen.
- Being tested
- Apioc Contact Lens
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apioc Contact LensDevice
Measurement of corneal oxygen uptake with contact lens wear.
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Oxygen Uptake Rate
uptake of oxygen by human cornea in vivo
Measured: up to 45 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start15 Jul 2019
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens-Induced Corneal Disorder of Both Eyes (Diagnosis)Studies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lentechs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031118
- Sponsor's protocol ID
- Len-003
- Status last verified
- Oct 2023
- First submitted
- 22 Jul 2019
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Oxygen Uptake With Apioc Contact Lenses
- ClinicalTrials.gov ID
- NCT04031118
- Acronym / sponsor ID
- Len-003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lentechs, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 24 Jul 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 purpose of this research is to determine if a new investigational contact lens shape allows the eye to get more oxygen.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Provide informed consent.
- Appear willing and able to adhere to instructions set forth in the protocol.
- Be between the ages of 18 and 45.
- Be an experienced contact lens wearer.
- Be an eyecare clinician or clinician-in-training.
Key exclusion criteria (7 listed)
- Irregular corneal astigmatism.
- Use of topical or systemic antihistamines within the previous week.
- Use of topical ophthalmic drops within the previous two days.
- History of corneal surgery.
- Currently pregnant or lactating.
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 LensMeasurement of corneal oxygen uptake with contact lens wear. | Device | – |
Primary outcome
Corneal Oxygen Uptake Rate
Time frame: up to 45 seconds
uptake of oxygen by human cornea in vivo
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 10 Oct 2023.
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 Apioc Contact Lens in people with Contact Lens-Induced Corneal Disorder of Both Eyes (Diagnosis), 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 10 inclusion and 7 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 10 Oct 2023. 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?
Corneal Oxygen Uptake Rate (time frame: up to 45 seconds). 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 10 Oct 2023.