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OTX-CSI

Phase 1

Dry Eye Disease | Small molecule | Ophthalmology |Ocular Therapeutix, Inc.|Last Updated: Nov 14, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment153

FDA Designations

No designations recorded

Clinical trial landscape

OTX-CSI · 1 trial · 1 indication

Phase 1 1
NCT04362670Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.Dry Eye Disease
COMPLETED153 Analytics
PHASE1COMPLETED
Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.
Dry Eye Disease
NCT04362670153
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Study Endpoints

Primary Endpoints

Number of Subjects With At Least One (1) Treatment Emergent Adverse Event
From Screening to Study Exit, approximately 156 days.
Schirmer Test Score, CFB at Week 12
Change from Baseline at Week 12

A Schirmer test strip measures the amount of tear production and provides a unit of measure in millimeters (mm).

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
OTX-CSI-Cohort 1EXPERIMENTALFormulation 2A-.36 mg
OTX-CSI-Cohort 2EXPERIMENTALFormulation 1- .36 mg
HVPLACEBO_COMPARATORCohort 2: Formulation 2B
OTX-CSI- Cohort 2EXPERIMENTALFormulation 2A- .36 mg
HV-2PLACEBO_COMPARATORCohort 2: Formulation 3

Interventions

NameTypeDescription
OTX-CSIDRUGOTX-CSI intracanalicular insert
Placebo VehicleOTHERHydrogel Vehicle intracanalicular insert
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Dry eye disease diagnosis * VAS eye dryness severity score ≥ 30. Exclusion Criteria: * Are unwilling to discontinue use of contact lenses * Are unwilling to withhold use of artificial tears.

Countries:United States
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Competitive Landscape -Dry Eye Disease 7 trials

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV2PHASE3ABBV-444, REFRESH OPTIVE UD
Vanda Pharmaceuticals Inc.VNDA1PHASE2VSJ-110
Oculis Holding AGOCS1PHASE2licaminlimab
Alcon AGALC1N/AUndisclosed
Harrow, Inc.HROW1 - Undisclosed
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Frequently asked questions about OTX-CSI

What is OTX-CSI used for?

OTX-CSI is an investigational small molecule being developed for the treatment of Dry Eye Disease. It is administered to patients with this condition to evaluate its safety, tolerability, and efficacy. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes OTX-CSI?

OTX-CSI is being developed by Ocular Therapeutix, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol OCUL. The company is conducting clinical trials to assess the drug's potential in treating Dry Eye Disease.

What phase is OTX-CSI in?

OTX-CSI is in Phase 1 clinical development. A Phase 1 trial has been completed, which evaluated the safety, tolerability, and efficacy of the drug in subjects with Dry Eye Disease. The drug remains investigational and is not yet approved for commercial use.

What clinical trials is OTX-CSI in?

OTX-CSI has one completed clinical trial registered as NCT04362670. This Phase 1 study evaluated the safety, tolerability, and efficacy of OTX-CSI in 153 participants with Dry Eye Disease in the United States. The trial was randomized, double-blind, and placebo-controlled.

Is OTX-CSI FDA approved?

OTX-CSI is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Dry Eye Disease. A completed Phase 1 trial has assessed its safety and efficacy, but further clinical studies and regulatory review are required before any approval decision.