OTX-14-007: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis

NCT02445326 | Completed Phase 3 Results

• 1 other identifier: OTX-14-007
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

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

Conditions

Chronic Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (6)

• Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6

  Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None

  3 minutes

• Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6

  Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None

  5 minutes

• Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6

  Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None

  7 minutes

• Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6

  Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None

  7 minutes

• Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6

  Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None

  15 minutes

• Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6

  Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None

  20 minutes

Study Arms (2)

OTX-DP

EXPERIMENTAL

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

Drug: Dexamethasone

PV

PLACEBO COMPARATOR

PV (placebo drug delivery vehicle)

Other: Placebo Vehicle

Interventions

Dexamethasone DRUG

OTX-DP

Placebo Vehicle OTHER

PV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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)
• 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

Sponsors & Collaborators

• Ocular Therapeutix, Inc.: lead
• ORA, Inc.: collaborator

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jamie L. Metzinger, Medical Affairs
• Organization: Ocular Therapeutix

jmetzinger@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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: May 15, 2015
• Study Start: April 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 29, 2018
• Results First Posted: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share