OTX-15-002: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis

Phase 3

Completed

• Conditions: Chronic Allergic Conjunctivitis
• Interventions: Other: Placebo Vehicle; Drug: Dexamethasone

• Registration Number: NCT02988882
• Lead Sponsor: Ocular Therapeutix, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Primary Completion: 2016-04-27
• Study Completion: 2016-04-27
• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-07
• Study First Posted: 2016-12-09
• Results First Submitted: 2017-11-15
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-28
• Results First Posted: 2018-04-30
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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
• Use any of the disallowed medications during the period indicated
• History of IOP increase as a result of steroid treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PV	Placebo Vehicle	PV (placebo drug delivery vehicle)
OTX-DP	Dexamethasone	OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use

Primary Outcome Measures

Name	Time	Method
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6	7 minutes	Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching
Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6	5 minutes	Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching