A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis

Ocular Therapeutix, Inc.96 enrolled

Overview

The objective of the study is to evaluate the efficacy and safety of OTX-DP as a dexamethasone ophthalmic insert when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of allergic conjunctivitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Allergic Conjunctivitis

Interventions

Dexamethasone, 0.4mgDRUG

Ophthalmic Insert

Placebo plug with no drugDEVICE

Ophthalmic Insert

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen * Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation Exclusion Criteria: * History of refractive surgery (including LASIK procedures) within the past 2 years * History of retinal detachment, diabetic retinopathy, or active retinal disease * Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit * History of IOP increase as a result of steroid treatment * A female who is currently pregnant, planning a pregnancy, or lactating

Locations (6)

Vision Institute

Colorado Springs, Colorado, United States

The Eye Care Institute

Louisville, Kentucky, United States

Andover Eye Associates

Raynham, Massachusetts, United States

Silverstein Eye Centers

Kansas City, Missouri, United States

Outcomes

Primary Outcomes

Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 (7 Days Post-insertion)

Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit Increments; 0 = None 0.5 = An intermittent tickle sensation possibly localized in the corner of the eye 1.0 = An intermittent tickle sensation involving more than just the corner of the eye 1.5 = An intermittent all-over tickling sensation 2.0 = A mild continuous itch (can be localized) without desire to rub 2.5 = A moderate, diffuse continuous itch with desire to rub 3.0 = A severe itch with desire to rub 3.5 = A severe itch improved with minimal rubbing 4.0 = An incapacitating itch with an irresistible urge to rub 0.5 unit increments ARE allowed

Time frame: 3 minutes

Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion)

Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0 = None 0.5 = An intermittent tickle sensation possibly localized in the corner of the eye 1.0 = An intermittent tickle sensation involving more than just the corner of the eye 1.5 = An intermittent all-over tickling sensation 2.0 = A mild continuous itch (can be localized) without desire to rub 2.5 = A moderate, diffuse continuous itch with desire to rub 3.0 = A severe itch with desire to rub 3.5 = A severe itch improved with minimal rubbing 4.0 = An incapacitating itch with an irresistible urge to rub 0.5 unit increments ARE allowed

Time frame: 5 minutes

Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion)

Time frame: 7 minutes

Data from ClinicalTrials.gov

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