OTX-14-001: A Phase 2 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 2 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: NCT02062905
• Other study ID #: OTX-14-001
• Status: Completed
• Phase: Phase 2
• Start date: March 2014
• Est. completion date: November 2014

Study information

• Verified date: September 2017
• 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: 68
• Est. completion date: November 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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 ocular surgical intervention within the past 3 months

• Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit

• Use any of the following disallowed medications during the period indicated

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	Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; "0" = no itching)	14 days post insertion
Secondary	Conjunctival Redness	Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; "0" = no redness)	14 days post insertion