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

Ocular Therapeutix, Inc.43 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dry Eye

Interventions

DexamethasoneDRUG

Placebo VehicleOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Total Corneal Fluorescein Staining

National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining)

Time frame: Day 15

Total Corneal Fluorescein Staining

National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining)

Time frame: Day 30

Total Conjunctival Lissamine Green Staining

National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining)

Time frame: Day 15

Total Conjunctival Lissamine Green Staining

National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining)

Time frame: Day 30

Data from ClinicalTrials.gov

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