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

Phase 3

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Dexamethasone, 0.4mg; Device: Placebo plug with no drug

• Registration Number: NCT04050865
• Lead Sponsor: Ocular Therapeutix, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-05
• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-07
• Study First Posted: 2019-08-08
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28
• Results First Submitted: 2021-08-10
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-09
• Last Update Submitted: 2021-09-09
• Results First Posted: 2021-10-07
• Last Update Posted: 2021-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OTX-DP	Dexamethasone, 0.4mg	-
Placebo	Placebo plug with no drug	-

Primary Outcome Measures

Name	Time	Method
Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 (7 Days Post-insertion)	3 minutes	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
Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion)	7 minutes	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

Trial Locations

Locations (6)

Total Eye Care, P.A.; 🇺🇸 Memphis, Tennessee, United States

Eye Associates of Texas; 🇺🇸 Round Rock, Texas, United States

Silverstein Eye Centers; 🇺🇸 Kansas City, Missouri, United States

Andover Eye Associates; 🇺🇸 Raynham, Massachusetts, United States

Vision Institute; 🇺🇸 Colorado Springs, Colorado, United States

The Eye Care Institute; 🇺🇸 Louisville, Kentucky, United States