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

NCT04050865 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CLN-Protocol-0052
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 6

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.

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (3)

• 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

  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

  5 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

  7 minutes

Study Arms (2)

OTX-DP

EXPERIMENTAL

Drug: Dexamethasone, 0.4mg

Placebo

PLACEBO COMPARATOR

Device: Placebo plug with no drug

Interventions

Dexamethasone, 0.4mg DRUG

Ophthalmic Insert

Also known as: OTX-DP

OTX-DP

Placebo plug with no drug DEVICE

Ophthalmic Insert

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ocular Therapeutix, Inc.: lead

Study Sites (6)

Vision Institute

Colorado Springs, Colorado, 80907, United States

Location

The Eye Care Institute

Louisville, Kentucky, 40206, United States

Location

Andover Eye Associates

Raynham, Massachusetts, 02767, United States

Location

Silverstein Eye Centers

Kansas City, Missouri, 64133, United States

Location

Total Eye Care, P.A.

Memphis, Tennessee, 38119, United States

Location

Eye Associates of Texas

Round Rock, Texas, 78681, United States

Location

Related Publications (1)

• Kenyon K, McLaurin EB, Silverstein SM, Meyer JC, Anderson E, Patel RH, Gomes PJ, Reilly E, Vantipalli S, Cheung MW, Goldstein MH. A Randomized, Multicenter Phase 3 Clinical Trial Evaluating Intracanalicular Dexamethasone Insert for the Treatment of Allergic Conjunctivitis. Clin Ophthalmol. 2024 Sep 21;18:2671-2684. doi: 10.2147/OPTH.S476419. eCollection 2024.

  PMID: 39328900 DERIVED

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Ocular Therapeutix

clinicalaffairs@ocutx.com

781-357-4000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 8, 2019
• Study Start: August 5, 2019
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: October 7, 2021
• Results First Posted: October 7, 2021

Record last verified: 2021-09

Locations

US (6)