Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.

Study Overview
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Brief Summary
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To assess the safety, tolerability and efficacy of a single dose of OTX-CSI, a sustained release cyclosporine drug product, in subjects with dry eye disease.

Detailed Description
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Randomized, multi-center, double-masked, vehicle-controlled, Phase 1/2 study to evaluate the safety, tolerability, and efficacy of OTX-CSI in subjects with dry eye disease. The subjects will be followed for approximately 16 weeks after product insertion

Official Title
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A Randomized, Multi-center, Double-masked, Vehicle-controlled, Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI (Cyclosporine Ophthalmic Insert) for Intracanalicular Use for the Treatment of Subjects With Dry Eye Disease (DED)

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: OTX-CSI
* Other: Placebo Vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTX-CSI-Cohort 1<br>Formulation 2A-.36 mg | Drug: OTX-CSI<br>* OTX-CSI intracanalicular insert<br>|
| Experimental: OTX-CSI-Cohort 2<br>Formulation 1- .36 mg | Drug: OTX-CSI<br>* OTX-CSI intracanalicular insert<br>|
| Placebo Comparator: HV<br>Cohort 2: Formulation 2B | Other: Placebo Vehicle<br>* Hydrogel Vehicle intracanalicular insert<br>|
| Experimental: OTX-CSI- Cohort 2<br>Formulation 2A- .36 mg | Drug: OTX-CSI<br>* OTX-CSI intracanalicular insert<br>|
| Placebo Comparator: HV-2<br>Cohort 2: Formulation 3 | Other: Placebo Vehicle<br>* Hydrogel Vehicle intracanalicular insert<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With At Least One (1) Treatment Emergent Adverse Event | 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 | A Schirmer test strip measures the amount of tear production and provides a unit of measure in millimeters (mm). | Change from Baseline at Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cyclosporine, Intracanalicular insert