Clinical trial NCT04747977: To Assess the Efficacy and Safety of OTX-DED for the Short-term Treatment of Signs and Symptoms of Dry Eye Disease
Official title: A Randomized, Double-Masked, Vehicle-Controlled, Phase 2 Study to Evaluate 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Keywords: dexamethasone ophthalmic insert
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-10
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center).
timeFrame: Change from baseline (Day 1) at Visit 4 (Day 15)
Secondary outcomes:
Other outcomes:
Locations:
city: Inglewood
country: United States
facility: Ocular Therapeutix
state: California
city: Mission Hills
country: United States
facility: Ocular Therapeutix, Inc
state: California
city: Newport Beach
country: United States
facility: Ocular Therapeutix, Inc.
state: California
city: Santa Ana
country: United States
facility: Ocular Therapeutix, Inc.
state: California
city: Delray Beach
country: United States
facility: Ocular Therapeutix, Inc.
state: Florida
city: Largo
country: United States
facility: Ocular Therapeutix, Inc.
state: Florida
city: Warrenville
country: United States
facility: Ocular Therapeutix
state: Illinois
city: Indianapolis
country: United States
facility: Ocular Therapeutix, Inc.
state: Indiana
city: Kansas City
country: United States
facility: Ocular Therapeutix
state: Missouri
city: Saint Louis
country: United States
facility: Ocular Therapeutix, Inc.
state: Missouri
city: Poughkeepsie
country: United States
facility: Ocular Therapeutix
state: New York
city: Raleigh
country: United States
facility: Ocular Therapeutix, Inc.
state: North Carolina
city: Cranberry Township
country: United States
facility: Ocular Therapeutix, Inc.
state: Pennsylvania
city: Memphis
country: United States
facility: Ocular Therapeutix, Inc.
state: Tennessee
city: League City
country: United States
facility: Ocular Therapeutix, Inc.
state: Texas
Study officials:
References: