OTX-14-001: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis

Ocular Therapeutix

Status and phase: Completed; Phase 2

Conditions: Chronic Allergic Conjunctivitis

Treatments: Drug: Dexamethasone; Other: Placebo Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02062905

OTX-14-001

Details and patient eligibility

About

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 chronic allergic conjunctivitis

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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 ocular surgical intervention within the past 3 months
• Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
• Use any of the following disallowed medications during the period indicated

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups, including a placebo group

OTX-DP

Experimental group

Description:

OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use

Treatment:

Drug: Dexamethasone

PV

Placebo Comparator group

Description:

PV (placebo drug delivery vehicle)

Treatment:

Other: Placebo Vehicle