A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery

Study Overview
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Brief Summary
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A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery

Detailed Description
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A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated with Cataract Surgery

Official Title
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A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery

Conditions
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Cataract

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects at least 40 years of age scheduled for cataract surgery Best corrected visual acuity (BCVA) of 20/30-20/200 in the study eye Must be considered by the investigator to have visual (VA) acuity potential greater than 20/30 in the study eye. Exclusion Criteria: Use of any corticosteroids within 7 days prior to Day 0 Injection of any corticosteroids, systemic immunomodulators or alkylating agents into any body tissue within 90 days Score greater than 0 on the Ocular Pain Assessment in the study eye at Screening.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Prospective, Randomized, Double-masked, Placebo-controlled,Parallel-design, Multicenter Study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEXYCU<br>DEXYCU, 103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg | Drug: Dexycu<br>* 103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg<br>|
| Placebo Comparator: Placebo<br>Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg | Other: Placebo/Vehicle<br>* Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8 |  | Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with absence of ocular pain in the study eye at Days 1, 3, 15, and 30 |  | Days 1, 3, 15, and 30 | 
| Mean ocular pain scores in the study eye | Numerical Ocular Pain Scale from 0-10 with 0 being no pain and 10 being most severe | Days 1, 3, 8, 15 and 30 | 
| Proportion of subjects with absence of cells in the AC of the study eye |  | Days 1, 3, 8, 15 and 30 | 
| Proportion of subjects with absence of flare in the AC of the study eye |  | Days 1, 3, 8, 15 and 30 | 
| Mean AC cell score in the study eye | AC count by Slit Lamp Biomicroscopy with 0 being none and 4 being most severe | Days 1, 3, 8, 15 and 30 | 
| Mean AC flare score in the study eye | AC count by Slit Lamp Biomicroscopy with 0 being absent and 4 being strong intensity | Days 1, 3, 8, 15 and 30 | 
| Rates of ocular (study eye and fellow eye) and non-ocular TEAEs |  | up to day 30 |