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A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract

NCT04539548 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-04-15

No results posted yet for this study

Summary

To assess the safety of Dextenza compared to an active control, prednisolone acetate suspension, for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract.

Conditions

  • Cataract

Interventions

DRUG

Dextenza Ophthalmic Insert

0.4mg insert for intracanalicular use

DRUG

Prednisolone acetate ophthalmic suspension USP 1%

1 drop at end of surgery, followed by: 1 drop 4 x QID for one week. 1 drop 3 x QID for one week. 1 drop BID for one week. 1 drop QD for one week

Sponsors & Collaborators

  • Ocular Therapeutix, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-04
Primary Completion
2023-12-21
Completion
2023-12-21
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 NCT04539548 on ClinicalTrials.gov