To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease

Ocular Therapeutix

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Drug: OTX-DED

Study type: Interventional

Funder types: Industry

Identifiers

NCT04747977

OTX-DED-2020-201

Details and patient eligibility

About

To assess the efficacy and safety of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease.

Full description

Randomized, double-masked, vehicle-controlled, phase 2 study evaluating the efficacy and safety of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of signs and symptoms of Dry Eye Disease (DED). The subjects will be followed for approximately 2-3 months from screening to the last visit.

Enrollment: 172 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Dry Eye Disease diagnosis
• VAS eye dryness severity score ≥ 40.

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: Parallel Assignment

Masking: Double Blind

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172 participants in 3 patient groups, including a placebo group

OTX-DED 0.2mg

Experimental group

Description:

Approximately 50 subjects

Treatment:

Drug: OTX-DED

Drug: OTX-DED

Drug: OTX-DED

OTX-DED 0.3mg

Experimental group

Description:

Approximately 50 subjects

Treatment:

Drug: OTX-DED

Drug: OTX-DED

Drug: OTX-DED

Hydrogel Vehicle (HV)

Placebo Comparator group

Description:

Approximately 50 subjects

Treatment:

Drug: OTX-DED

Drug: OTX-DED

Drug: OTX-DED