Ocular HypertensionPhase 1NCT04360174
CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension
A Phase 1 study testing OTX-TIC in people with Ocular Hypertension and Open Angle Glaucoma, run by Ocular Therapeutix, Inc. at 5 sites in United States.
Trial summary
To assess the safety, tolerability and efficacy of a single sustained release dose of OTX-TIC, a sustained release travoprost drug product, in subjects with primary open-angle glaucoma or ocular hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Hypertension, Open Angle Glaucoma
- What is being tested?
- OTX-TIC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Apr 2018to 24 May 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a documented diagnosis of ocular hypertension or primary open-angle glaucoma
- Have IOP that is currently controlled as assessed by the Investigator
- Have open, normal appearing anterior chamber angles as determined by gonioscopy
Who cannot join
- Have closed angle glaucoma, narrow angle glaucoma, pseudoexfoliation syndrome, pseudoexfoliation glaucoma, pigment dispersion or pigmentary glaucoma, glaucoma diagnosis prior to 15 years of age, inflammatory, neovascular or other secondary
- Have a known or suspected allergy and/or hypersensitivity to a prostaglandin (i.e. travoprost), fluorescein or to any component of the study products
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Ocular Therapeutix, Inc.
Austin, Texas, 78731
Ocular Therapeutix, Inc.
Petaluma, California, 94954
Ocular Therapeutix, Inc.
Racine, Wisconsin, 53405
Ocular Therapeutix, Inc
Roswell, Georgia, 30076
Ocular Therapeutix, Inc.
Torrance, California, 90505
About this study
Official title: A Prospective, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of OTX-TIC (Travoprost) Implant in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
To assess the safety, tolerability and efficacy of a single sustained release dose of OTX-TIC, a sustained release travoprost drug product, in subjects with primary open-angle glaucoma or ocular hypertension.
Read the detailed description
This is a prospective, multicenter, open label study, to evaluate the safety, tolerability and efficacy of OTX-TIC intracameral implant in subjects with primary open-angle glaucoma or ocular hypertension. The subjects will be followed for approximately 7 months (one-month washout and 6 months follow-up after injected of the OTX-TIC implant).
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Being tested
- OTX-TIC
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTX-TICDrug
OTX-TIC implant is injection in the anterior chamber of the eye
| Study group | Role | What they receive |
|---|---|---|
| OTX-TIC-Cohort 1 | Experimental | 15 µg (formulation1) implant Receives: Drug: OTX-TIC |
| OTX-TIC-Cohort 2 | Experimental | 26 µg (formulation1) implant Receives: Drug: OTX-TIC |
| OTX-TIC-Cohort 3 | Experimental | 15 µg (formulation 2) implant Receives: Drug: OTX-TIC |
| OTX-TIC-Cohort 4 | Experimental | 5 µg (formulation 3) implant Receives: Drug: OTX-TIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Treatment Emergent Adverse Events
All adverse events will be captured throughout the study
Measured: Through study completion, 6 months
Efficacy Outcome
IOP measurements at 8 am
Measured: Diurnal IOP [12 Week Visit]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start25 Apr 2018
- Primary completion24 May 2021
- Study completion24 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ocular HypertensionStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Sequential: Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies
- Masking
- None (open label)
- Enrolment
- 19 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
- NCT04360174
- Sponsor's protocol ID
- CLN-Protocol-0045
- Status last verified
- Sep 2024
- First submitted
- 20 Mar 2020
- Last updated
- 1 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of OTX-TIC (Travoprost) Implant in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT04360174
- Acronym / sponsor ID
- CLN-Protocol-0045
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Ocular Therapeutix, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- 24 May 2021 (actual)
- Study completion
- 24 May 2021 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Posted 1 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety, tolerability and efficacy of a single sustained release dose of OTX-TIC, a sustained release travoprost drug product, in subjects with primary open-angle glaucoma or ocular hypertension.
Detailed description
This is a prospective, multicenter, open label study, to evaluate the safety, tolerability and efficacy of OTX-TIC intracameral implant in subjects with primary open-angle glaucoma or ocular hypertension. The subjects will be followed for approximately 7 months (one-month washout and 6 months follow-up after injected of the OTX-TIC implant).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Sequential: Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies
| Arm | Type | Receives |
|---|---|---|
| OTX-TIC-Cohort 1 | Experimental | Drug: OTX-TIC15 µg (formulation1) implant |
| OTX-TIC-Cohort 2 | Experimental | Drug: OTX-TIC26 µg (formulation1) implant |
| OTX-TIC-Cohort 3 | Experimental | Drug: OTX-TIC15 µg (formulation 2) implant |
| OTX-TIC-Cohort 4 | Experimental | Drug: OTX-TIC5 µg (formulation 3) implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a documented diagnosis of ocular hypertension or primary open-angle glaucoma
- Have IOP that is currently controlled as assessed by the Investigator
- Have open, normal appearing anterior chamber angles as determined by gonioscopy
Key exclusion criteria (2 listed)
- Have closed angle glaucoma, narrow angle glaucoma, pseudoexfoliation syndrome, pseudoexfoliation glaucoma, pigment dispersion or pigmentary glaucoma, glaucoma diagnosis prior to 15 years of age, inflammatory, neovascular or other secondary
- Have a known or suspected allergy and/or hypersensitivity to a prostaglandin (i.e. travoprost), fluorescein or to any component of the study products
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 |
|---|---|---|
| OTX-TICOTX-TIC implant is injection in the anterior chamber of the eye | Drug | OTX-TIC-Cohort 1, OTX-TIC-Cohort 2, OTX-TIC-Cohort 3, OTX-TIC-Cohort 4 |
Primary outcome
Ocular Treatment Emergent Adverse Events
Time frame: Through study completion, 6 months
All adverse events will be captured throughout the study
Efficacy Outcome
Time frame: Diurnal IOP [12 Week Visit]
IOP measurements at 8 am
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OTX-TIC in people with Ocular Hypertension and Open Angle Glaucoma, run by Ocular Therapeutix, Inc. at 5 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 3 inclusion and 2 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 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ocular Treatment Emergent Adverse Events (time frame: Through study completion, 6 months). The study lists 2 primary outcomes in all. 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 1 Oct 2024.