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Study of Dexycu in Treating Intraocular Inflammation

NCT06429306 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2024-08-26

No results posted yet for this study

Summary

This is a phase III, prospective, randomised, double-masked, placebo-controlled, parallel-design, multicenter study of the efficacy, safety and pharmacokinetics of 9% dexamethasone intraocular injection for the treatment of inflammation associated with cataract surgery.

Conditions

Interventions

DRUG

Dexycu

5ul dexamethasone, concentration: 103.4 μg/μl, equivalent to 517μg dexamethasone

DRUG

Placebo

Acetyl triethyl citrate

Sponsors & Collaborators

  • Ocumension Therapeutics (Shanghai) Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Zhixun Li · Ocumension Therapeutics (Shanghai) Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-22
Primary Completion
2023-11-24
Completion
2024-04-09
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06429306 on ClinicalTrials.gov