Clinical trial NCT04362670: Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.
Official title: A Randomized, Multi-center, Double-masked, Vehicle-controlled, Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI (Cyclosporine Ophthalmic Insert) for Intracanalicular Use for the Treatment of Subjects With Dry Eye Disease (DED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dry Eye Disease
Keywords: Cyclosporine
Intracanalicular insert
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-27
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential: Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With At Least One (1) Treatment Emergent Adverse Event
timeFrame: From Screening to Study Exit, approximately 156 days.
measure: Schirmer Test Score, CFB at Week 12
timeFrame: Change from Baseline at Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Ocular Therapeutix, Inc.
state: California
city: Inglewood
country: United States
facility: Ocular Therapeutix, Inc.
state: California
city: Mission Hills
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: Lake Villa
country: United States
facility: Ocular Therapeutix, Inc.
state: Illinois
city: Kansas City
country: United States
facility: Ocular Therapeutix, Inc.
state: Missouri
city: Saint Louis
country: United States
facility: Ocular Therapeutix, Inc
state: Missouri
city: Saint Louis
country: United States
facility: Ocular Therapeutix
state: Missouri
city: Cleveland
country: United States
facility: Ocular Therapeutix, Inc.
state: Ohio
city: Cranberry Township
country: United States
facility: Ocular Therapeutix, Inc.
state: Pennsylvania
city: Memphis
country: United States
facility: Ocular Therapeutix, Inc.
state: Tennessee
city: El Paso
country: United States
facility: Ocular Therapeutix, Inc.
state: Texas
city: Lakeway
country: United States
facility: Ocular Therapeutix
state: Texas
city: Murray
country: United States
facility: Ocular Therapeutix, Inc.
state: Utah
Study officials:
References: