Study Stopped
No longer pursuing indication
A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery
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
1 other identifier
interventional
N/A
0 countries
N/A
Brief Summary
A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2022
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedFirst Submitted
Initial submission to the registry
September 16, 2022
CompletedFirst Posted
Study publicly available on registry
September 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedAugust 11, 2025
August 1, 2025
1 year
September 16, 2022
August 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8
Day 8
Secondary Outcomes (7)
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
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
- +2 more secondary outcomes
Study Arms (2)
DEXYCU
EXPERIMENTALDEXYCU, 103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg
Placebo
PLACEBO COMPARATORPlacebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg
Interventions
Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2022
First Posted
September 22, 2022
Study Start
September 1, 2022
Primary Completion
September 1, 2023
Study Completion
September 1, 2023
Last Updated
August 11, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share