Healthy VolunteersOCDCNCT03488017
Ocular Coil Drug Delivery Comfort Trial
A study testing Ocular Coil in people with Healthy Volunteers, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The Ocular Coil is intended to provide drug delivery to the ocular surface. This study will evaluate the safety and tolerability of the placebo Ocular Coil in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Ocular Coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2018to 2 Aug 2019
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years old
- Informed and having given informed consent
- Willing and able to comply with scheduled visits and other study procedures
Who cannot join
- Subjects with a history of eye disease that can make them vulnerable for irritation by the coil.
- Subjects wearing contact lenses (unless they are willing to replace them for glasses for the duration of the study).
- Subjects using eye drops (during the study).
- Subjects with an Oriental/Asian lid crease, because of their narrow fornix.
- Subjects who do not speak and/or write Dutch properly.
- Subjects with a history of serious adverse reaction or hypersensitivity to components of the ocular coil. or to ophthalmic anaesthetics
- Women who are pregnant or nursing their child, or have the intention to become pregnant during the course of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Tolerability of an Ocular Coil
The Ocular Coil is intended to provide drug delivery to the ocular surface. This study will evaluate the safety and tolerability of the placebo Ocular Coil in healthy subjects.
Read the detailed description
This study is designed to evaluate the safety and comfort of a placebo Ocular Coil for 28 days in 40 healthy subjects.
- Conditions
- Healthy Volunteers
- Being tested
- Ocular Coil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular CoilDevice
Non-invasive ocular device
| Study group | Role | What they receive |
|---|---|---|
| Placebo Ocular Coil (left eye) | Experimental | Left eye Receives: Device: Ocular Coil |
| Placebo Ocular Coil (right eye) | Experimental | Right eye Receives: Device: Ocular Coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in terms of ocular irritation
Ocular irritation is assessed by slit lamp microscopy through evaluation of the ocular redness, inflammatory cells and flare.
Measured: 28 days
Secondary outcomes (3)
Total time of Ocular Coil retention
The total number of days that the Ocular Coil is worn by the participant (from placement until removal) is recorded.
Measured: 28 days
Percentage of Participants in Each Response Category of Subject Comfort
Subject comfort is assessed via a custom-made questionnaire. This questionnaire includes several questions related to eye comfort (itchy feeling, foreign feeling, etc.) and uses a 5-point scale (from agree to do not agree) and a 4-point scale (from always to never). The percentage of participants in each response category is recorded.
Measured: 28 days
Incidence of ocular adverse events
Incidence of ocular adverse events related to the Ocular Coil or the associated procedures (placement and removal) is evaluated.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start1 Jun 2018
- Primary completion2 Aug 2019
- Study completion2 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488017
- Sponsor's protocol ID
- 161042
- Acronym
- OCDC
- Status last verified
- Aug 2019
- First submitted
- 19 Mar 2018
- Last updated
- 8 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Tolerability of an Ocular Coil
- ClinicalTrials.gov ID
- NCT03488017
- Acronym / sponsor ID
- OCDC / 161042
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 4 Apr 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.
The Ocular Coil is intended to provide drug delivery to the ocular surface. This study will evaluate the safety and tolerability of the placebo Ocular Coil in healthy subjects.
Detailed description
This study is designed to evaluate the safety and comfort of a placebo Ocular Coil for 28 days in 40 healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Ocular Coil (left eye) | Experimental | Device: Ocular CoilLeft eye |
| Placebo Ocular Coil (right eye) | Experimental | Device: Ocular CoilRight eye |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 75 years old
- Informed and having given informed consent
- Willing and able to comply with scheduled visits and other study procedures
Key exclusion criteria (7 listed)
- Subjects with a history of eye disease that can make them vulnerable for irritation by the coil.
- Subjects wearing contact lenses (unless they are willing to replace them for glasses for the duration of the study).
- Subjects using eye drops (during the study).
- Subjects with an Oriental/Asian lid crease, because of their narrow fornix.
- Subjects who do not speak and/or write Dutch properly.
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 |
|---|---|---|
| Ocular CoilNon-invasive ocular device | Device | Placebo Ocular Coil (left eye), Placebo Ocular Coil (right eye) |
Primary outcome
Change from baseline in terms of ocular irritation
Time frame: 28 days
Ocular irritation is assessed by slit lamp microscopy through evaluation of the ocular redness, inflammatory cells and flare.
3 secondary outcomes
Total time of Ocular Coil retention
Time frame: 28 days
Percentage of Participants in Each Response Category of Subject Comfort
Time frame: 28 days
Incidence of ocular adverse events
Time frame: 28 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 8 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Screening Protocol
Pain
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 Ocular Coil in people with Healthy Volunteers, run by Maastricht University Medical Center at 1 site in Netherlands.
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 3 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 8 Aug 2019. 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 Netherlands. 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?
Change from baseline in terms of ocular irritation (time frame: 28 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 8 Aug 2019.