Clinical trial
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
Name
EYP-DIP-302
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
Trial arms
Trial start
2022-09-01
Estimated PCD
2023-09-01
Trial end
2023-09-01
Status
Withdrawn
Phase
Early phase I
Treatment
Dexycu
103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg
Arms:
DEXYCU
Placebo/Vehicle
Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg
Arms:
Placebo
Primary endpoint
Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8
Day 8
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, Randomized, Double-masked, Placebo-controlled,Parallel-design, Multicenter Study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Triple (Participant, Investigator, Outcomes Assessor)', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2024-04-03
1 organization
1 product
1 indication
Product
DexycuIndication
CataractOrganization
EyePoint Pharmaceuticals