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

Study Overview
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Brief Summary
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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

Official Title
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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®)

Conditions
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Chronic Allergic Conjunctivitis

Intervention / Treatment
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* Drug: Dexamethasone
* Other: Placebo Vehicle


Participation Criteria
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Eligibility Criteria
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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) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OTX-DP<br>OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use | Drug: Dexamethasone<br> <br> |
| Placebo Comparator: PV<br>PV (placebo drug delivery vehicle) | Other: Placebo Vehicle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |