A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery
Study Details
Study Description
Brief Summary
A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
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
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: DEXYCU DEXYCU, 103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg |
Drug: Dexycu
103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg
|
Placebo Comparator: Placebo Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg |
Other: Placebo/Vehicle
Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg
|
Outcome Measures
Primary Outcome Measures
- Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8 [Day 8]
Secondary Outcome Measures
- 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 [Days 1, 3, 8, 15 and 30]
Numerical Ocular Pain Scale from 0-10 with 0 being no pain and 10 being most severe
- 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 [Days 1, 3, 8, 15 and 30]
AC count by Slit Lamp Biomicroscopy with 0 being none and 4 being most severe
- Mean AC flare score in the study eye [Days 1, 3, 8, 15 and 30]
AC count by Slit Lamp Biomicroscopy with 0 being absent and 4 being strong intensity
- Rates of ocular (study eye and fellow eye) and non-ocular TEAEs [up to day 30]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female subjects at least 40 years of age scheduled for cataract surgery
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Best corrected visual acuity (BCVA) of 20/30-20/200 in the study eye
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Must be considered by the investigator to have visual (VA) acuity potential greater than 20/30 in the study eye.
Exclusion Criteria:
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Use of any corticosteroids within 7 days prior to Day 0
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Injection of any corticosteroids, systemic immunomodulators or alkylating agents into any body tissue within 90 days
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Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- EyePoint Pharmaceuticals, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EYP-DIP-301