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A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1%

NCT04273282 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-12-11

No results posted yet for this study

Summary

This is a post-approval, open-label, randomized, self-controlled prospective clinical study to evaluate the safety and ocular efficacy of Dexycu in controlling postoperative ocular pain and inflammation associated with cataract surgery.

Conditions

  • Cataract

Interventions

DRUG

Dexycu intracameral dexamethasone

To evaluate the safety and ocular efficacy of Dexycu.

DRUG

Prednisolone Acetate

To evaluate the safety and ocular efficacy, and patient acceptance of post cataract surgery drug treatment regimen that minimizes topical medications.

Sponsors & Collaborators

  • Research Insight LLC

    lead INDUSTRY

Principal Investigators

  • John Hovanesian, MD · Research Insight LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2020-11-24
Completion
2020-11-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04273282 on ClinicalTrials.gov