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COMPLETED Phase 4

Pediatric Zylet Safety and Efficacy Study

NCT00420628 · View on ClinicalTrials.gov ↗

Study Summary

A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum)

Conditions Studied

Interventions

  • DRUG vehicle
  • DRUG loteprednol etabonate/tobramycin opthalmic suspension

Study Locations (1)

Pennsylvania

  • Pediatric Ophthalmology of Erie — Erie

Trial Details

FieldValue
Enrollment Target 108 participants
Start Date 2006-11
Est. Completion 2009-06
Phase Phase 4

Sponsor

Bausch & Lomb Incorporated

78 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00420628

The ClinicalTrials.gov registry entry for NCT00420628 describes a study currently listed as completed. It is categorized as Phase 4, 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 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch & Lomb Incorporated, which has 78 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Chalazion appearing as the primary indexed condition, and to 2 interventions — of which vehicle 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: NCT00420628 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. 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 NCT00420628 about?

NCT00420628 is a clinical study titled "Pediatric Zylet Safety and Efficacy Study". A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum)

What is the current status of trial NCT00420628?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 108 participants. The study started on 2006-11. Estimated completion is 2009-06.

What conditions does trial NCT00420628 study?

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

What interventions are being tested in trial NCT00420628?

The interventions under investigation include: vehicle (DRUG), loteprednol etabonate/tobramycin opthalmic suspension (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00420628?

This trial is sponsored by Bausch & Lomb Incorporated, which has 78 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00420628 being conducted?

This trial has 1 study location across Pennsylvania. 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