HealthyEarly Phase 1NCT04945824
A Human Factors Study to Evaluate a Novel Intracanalicular Insertion Device in Healthy Subjects
A Early Phase 1 study testing Dexamethasone Ophthalmic and Dilator in people with Healthy, run by Ocular Therapeutix, Inc. at 1 site in United States.
Trial summary
This is an open-label, multi-center, bilateral, human factors study designed to evaluate the utilization and safety of a novel intracanalicular insertion device in healthy subjects and to evaluate the concentration of DEXTENZA in tears. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dexamethasone Ophthalmic and Dilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 1 Nov 2022
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are a healthy adult subject aged 18 years or older with no known significant health problems
- Are willing to refrain from wearing contact lens for the duration of the study
- Are willing and able to comply with clinic visits and study related procedures
- Are willing and able to sign the informed consent form
Who cannot join
- Have known significant health problems
- Are women of reproductive potential
- Are breastfeeding
- Are a known steroid responder
- Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye
- Have a history of complete punctal occlusion in one or both punctum
Show all 9Show fewer
- Currently use topical ophthalmic steroid medications
- Are unwilling or unable to comply with the study protocol
- Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular
Trial locations and contacts
1 site in 1 country.
United States1 site
Ocular Therapeutix, Inc.
Sioux Falls, South Dakota, 57108
About this study
Official title: An Open-label, Multi-center, Bilateral, Human Factors Study to Evaluate the Utilization and Safety of a Novel Intracanalicular Insertion Device in Healthy Subjects
This is an open-label, multi-center, bilateral, human factors study designed to evaluate the utilization and safety of a novel intracanalicular insertion device in healthy subjects and to evaluate the concentration of DEXTENZA in tears. Each subject's participation is expected to last for approximately 1 month from the DEXTENZA insertion.
- Conditions
- Healthy
- Being tested
- Dexamethasone Ophthalmic, Dilator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone OphthalmicDrug
Insertion Device: A handheld mechanical device used by the clinician to dilate the punctum and deliver the DEXTENZA insert into the canaliculus; designed to be single-use and pre-loaded with a single DEXTENZA insert.
DilatorDevice
Intracanalicular Dilator Device
| Study group | Role | What they receive |
|---|---|---|
| Novel Intracanalicular Insertion Device | Experimental | Not described Receives: Drug: Dexamethasone Ophthalmic; Device: Dilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of insertion as assessed by Post-Insertion Investigator Questionnaire
Measured: Assessed at Visit 1 (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start1 Jun 2021
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Why it stopped: inserter device did not perform as expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocular Therapeutix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945824
- Sponsor's protocol ID
- OTX-DPI-2020-401
- Status last verified
- Feb 2023
- First submitted
- 1 Jun 2021
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Bilateral, Human Factors Study to Evaluate the Utilization and Safety of a Novel Intracanalicular Insertion Device in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04945824
- Acronym / sponsor ID
- OTX-DPI-2020-401
- Conditions
- Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inserter device did not perform as expected
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Ocular Therapeutix, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 30 Jun 2021 (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 is an open-label, multi-center, bilateral, human factors study designed to evaluate the utilization and safety of a novel intracanalicular insertion device in healthy subjects and to evaluate the concentration of DEXTENZA in tears. Each subject's participation is expected to last for approximately 1 month from the DEXTENZA insertion.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novel Intracanalicular Insertion Device | Experimental | Drug: Dexamethasone Ophthalmic, Device: Dilator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are a healthy adult subject aged 18 years or older with no known significant health problems
- Are willing to refrain from wearing contact lens for the duration of the study
- Are willing and able to comply with clinic visits and study related procedures
- Are willing and able to sign the informed consent form
Key exclusion criteria (9 listed)
- Have known significant health problems
- Are women of reproductive potential
- Are breastfeeding
- Are a known steroid responder
- Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye
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 |
|---|---|---|
| Dexamethasone OphthalmicInsertion Device: A handheld mechanical device used by the clinician to dilate the punctum and deliver the DEXTENZA insert into the canaliculus; designed to be single-use and pre-loaded with a single DEXTENZA insert. | Drug | Novel Intracanalicular Insertion Device |
| DilatorIntracanalicular Dilator Device | Device | Novel Intracanalicular Insertion Device |
Primary outcome
Ease of insertion as assessed by Post-Insertion Investigator Questionnaire
Time frame: Assessed at Visit 1 (Day 1)
Results and safety
The study was stopped early (reason given: inserter device did not perform as expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
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 Early Phase 1 study testing Dexamethasone Ophthalmic and Dilator in people with Healthy, run by Ocular Therapeutix, Inc. 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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 6 Feb 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: inserter device did not perform as expected). Results are not available in the source record.
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?
Ease of insertion as assessed by Post-Insertion Investigator Questionnaire (time frame: Assessed at Visit 1 (Day 1)). 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 6 Feb 2023.