OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye

Ocular Therapeutix

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Drug: Dexamethasone; Other: Placebo Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02468700

OTX-14-006

Details and patient eligibility

About

The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of dry eye disease

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Had a known history of dry eye disease
• Had a minimal Corneal Fluorescein Staining Score and OSDI score in each eye

Exclusion criteria

• History of intraocular inflammation in either eye
• Use of the anti-inflammatory or immunomodulating agents ocular or systemic for the duration of the study
• Uncontrolled glaucoma or is on medications to treat glaucoma
• History of IOP spikes in either eye
• Active epiphora

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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43 participants in 2 patient groups, including a placebo group

OTX-DP

Experimental group

Description:

OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use

Treatment:

Drug: Dexamethasone

PV

Placebo Comparator group

Description:

PV (placebo drug delivery vehicle)

Treatment:

Other: Placebo Vehicle