OTX-14-001: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
Phase 2
Completed
- Conditions
- Chronic Allergic Conjunctivitis
- Interventions
- Other: Placebo Vehicle
- Registration Number
- NCT02062905
- Lead Sponsor
- Ocular Therapeutix, Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OTX-DP Dexamethasone OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use PV Placebo Vehicle PV (placebo drug delivery vehicle)
- Primary Outcome Measures
Name Time Method Ocular Itching 14 days post insertion Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; "0" = no itching)
- Secondary Outcome Measures
Name Time Method Conjunctival Redness 14 days post insertion Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; "0" = no redness)