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COMPLETED Phase 3

Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification

NCT01579565 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study is to determine the safety, efficacy and pharmacokinetics of OMS302 (the study drug) for maintaining intraoperative mydriasis and preventing post operative pain in individuals undergoing Intraocular Lens Replacement (ILR) surgery.

Interventions

  • DRUG Placebo
  • DRUG OMS302

Study Locations (14)

Texas

  • — Austin
  • — Houston
  • — San Antonio

Missouri

  • — St Louis
  • — Washington

Arizona

  • — Chandler

California

  • — Los Angeles

Florida

  • — Fort Myers

Massachusetts

  • — Boston

New Mexico

  • — Albuquerque

New York

  • — New York

Trial Details

FieldValue
Enrollment Target 416 participants
Start Date 2012-04
Est. Completion 2013-01
Phase Phase 3

Sponsor

Omeros Corporation

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01579565

The ClinicalTrials.gov registry entry for NCT01579565 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 416 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Omeros Corporation, which has 6 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 Intraocular Lens Replacement appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT01579565 reports 14 study locations spanning 11 distinct geographic areas — top geographies include Texas, Missouri, Arizona. 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 NCT01579565 about?

NCT01579565 is a clinical study titled "Safety, Efficacy and Pharmacokinetics of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification". The purpose of this study is to determine the safety, efficacy and pharmacokinetics of OMS302 (the study drug) for maintaining intraoperative mydriasis and preventing post operative pain in individuals undergoing Intraocular Lens Replacement (ILR) surgery.

What is the current status of trial NCT01579565?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 416 participants. The study started on 2012-04. Estimated completion is 2013-01.

What conditions does trial NCT01579565 study?

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

What interventions are being tested in trial NCT01579565?

The interventions under investigation include: Placebo (DRUG), OMS302 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01579565?

This trial is sponsored by Omeros Corporation, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01579565 being conducted?

This trial has 14 study locations across Arizona, California, Florida, Massachusetts, Missouri. 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