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OTX-TIC

Phase 1

Ocular Hypertension | Small molecule | Ophthalmology |Ocular Therapeutix, Inc.|Last Updated: Oct 1, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

Clinical trial landscape

OTX-TIC · 1 trial · 2 indications

Phase 1 1
NCT04360174CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular HypertensionOcular Hypertension
COMPLETED19 Analytics
PHASE1COMPLETED
CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension
Ocular HypertensionUnlock trial analytics

Study Endpoints

Primary Endpoints

Ocular Treatment Emergent Adverse Events
Through study completion, 6 months

All adverse events will be captured throughout the study

Efficacy Outcome
Diurnal IOP [12 Week Visit]

IOP measurements at 8 am

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
OTX-TIC-Cohort 1EXPERIMENTAL15 µg (formulation1) implant
OTX-TIC-Cohort 2EXPERIMENTAL26 µg (formulation1) implant
OTX-TIC-Cohort 3EXPERIMENTAL15 µg (formulation 2) implant
OTX-TIC-Cohort 4EXPERIMENTAL5 µg (formulation 3) implant

Interventions

NameTypeDescription
OTX-TICDRUGOTX-TIC implant is injection in the anterior chamber of the eye
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * 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 Exclusion Criteria: * Have closed angle...

Countries:United States
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Competitive Landscape -Ocular Hypertension 8 trials

Frequently asked questions about OTX-TIC

What is OTX-TIC used for?

OTX-TIC is an investigational small molecule being developed for ocular hypertension. It is also being studied in open angle glaucoma, as the completed Phase 1 trial enrolled participants with either condition. The drug is administered in the eye and is intended to lower intraocular pressure.

Who makes OTX-TIC?

OTX-TIC is being developed by Ocular Therapeutix, Inc., a biopharmaceutical company traded on NASDAQ under the ticker OCUL. The company is focused on ophthalmology and is evaluating this small molecule in a Phase 1 clinical trial for ocular hypertension.

What phase is OTX-TIC in?

OTX-TIC is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by the FDA, and its safety and efficacy are still being evaluated in clinical studies.

What clinical trials is OTX-TIC in?

OTX-TIC has one completed clinical trial, NCT04360174, titled 'CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension.' This Phase 1 study enrolled 19 participants in the United States and was not randomized or double-blinded.

How does OTX-TIC work?

OTX-TIC is a small molecule designed to treat ocular hypertension. Its specific molecular target has not been disclosed, so the exact mechanism of action is not publicly detailed. The drug is being studied for its ability to lower intraocular pressure in patients with ocular hypertension or open angle glaucoma.