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

Ocular Therapeutix

Status and phase: Completed; Phase 3

Conditions: Allergic Conjunctivitis

Treatments: Device: Placebo plug with no drug; Drug: Dexamethasone, 0.4mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04050865

CLN-Protocol-0052

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups, including a placebo group

OTX-DP

Experimental group

Treatment:

Drug: Dexamethasone, 0.4mg

Placebo

Placebo Comparator group

Treatment:

Device: Placebo plug with no drug