Cataract
Conditions
Brief summary
A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery
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
Interventions
DRUGDexycu
103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg
OTHERPlacebo/Vehicle
Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg
Sponsors
EyePoint Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Prospective, Randomized, Double-masked, Placebo-controlled,Parallel-design, Multicenter Study
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8 | Day 8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 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 | — |
| 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 |
Outcome results
None listed