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

Ocular Therapeutix

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dry Eye Disease

Treatments: Drug: OTX-CSI; Other: Placebo Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT04362670

CLN-Protocol-0054

Details and patient eligibility

About

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.

Full description

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

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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153 participants in 5 patient groups, including a placebo group

OTX-CSI-Cohort 1

Experimental group

Description:

Formulation 2A-.36 mg

Treatment:

Drug: OTX-CSI

OTX-CSI-Cohort 2

Experimental group

Description:

Formulation 1- .36 mg

Treatment:

Drug: OTX-CSI

HV

Placebo Comparator group

Description:

Cohort 2: Formulation 2B

Treatment:

Other: Placebo Vehicle

OTX-CSI- Cohort 2

Experimental group

Description:

Formulation 2A- .36 mg

Treatment:

Drug: OTX-CSI

HV-2

Placebo Comparator group

Description:

Cohort 2: Formulation 3

Treatment:

Other: Placebo Vehicle