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COMPLETED Phase 3

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

NCT04539548 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG Dextenza Ophthalmic Insert
  • DRUG Prednisolone acetate ophthalmic suspension USP 1%

Study Locations (14)

Colorado

  • Ocular Therapeutix — Aurora
  • Ocular Therapeutix — Fort Collins

Minnesota

  • Ocular Therapeutix — Minneapolis
  • Ocular Therapeutix — Rochester

Florida

  • Ocular Therapeutix — Jacksonville

Indiana

  • Ocular Therapeutix — Indianapolis

Kentucky

  • Ocular Therapeutix — Lexington

Massachusetts

  • Ocular Therapeutix — Boston

Missouri

  • Ocular Therapeutix — St Louis

Pennsylvania

  • Ocular Therapeutix — Erie

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2020-09-04
Est. Completion 2023-12-21
Phase Phase 3

Sponsor

Ocular Therapeutix

39 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04539548

The ClinicalTrials.gov registry entry for NCT04539548 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ocular Therapeutix, which has 39 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Cataract appearing as the primary indexed condition, and to 2 interventions — of which Dextenza Ophthalmic Insert is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04539548 reports 14 study locations spanning 12 distinct geographic areas — top geographies include Colorado, Minnesota, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04539548 about?

NCT04539548 is a clinical study titled "A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract". 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.

What is the current status of trial NCT04539548?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2020-09-04. Estimated completion is 2023-12-21.

What conditions does trial NCT04539548 study?

This clinical trial studies the following conditions: Cataract. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04539548?

The interventions under investigation include: Dextenza Ophthalmic Insert (DRUG), Prednisolone acetate ophthalmic suspension USP 1% (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04539548?

This trial is sponsored by Ocular Therapeutix, which has 39 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04539548 being conducted?

This trial has 14 study locations across Colorado, Florida, Indiana, Kentucky, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial