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

Chronic Allergic Conjunctivitis Clinical Trial

Official title:

A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02988882
• Other study ID #: OTX-15-002
• Status: Completed
• Phase: Phase 3
• Start date: June 2015
• Est. completion date: April 27, 2016

Study information

• Verified date: March 2018
• Source: Ocular Therapeutix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: April 27, 2016
• Est. primary completion date: April 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Dexamethasone

Other:
• Placebo Vehicle

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ocular Therapeutix, Inc.	ORA, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6	Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching	3 minutes
Primary	Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6	Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching	5 minutes
Primary	Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6	Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=No itching	7 minutes