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COMPLETED Phase 3

Safety and Efficacy Assessment of Vismed® (Sodium Hyaluronate) for the Treatment of Dry Eye Syndrome

NCT00599716 · View on ClinicalTrials.gov ↗

Study Summary

The study is designed to assess the safety and efficacy of Vismed®, a special eye drop containing sodium hyaluronate, in the treatment of dry eye syndrome. Vismed® is being compared to another eye drop, identical in composition except that it does not contain the active ingredient, sodium hyaluronate. This eye drop is designed as the "vehicle." Some subjects are to receive Vismed® treatment, while others are to receive the vehicle; the assignment of subjects to receive either Vismed or vehicle is to be random. The two-week treatment phase is followed by a one week follow-up period to evaluate safety of Vismed®.

Conditions Studied

Interventions

  • DRUG vehicle
  • DRUG sodium hyaluronate

Study Locations (10)

Florida

  • Florida Eye Microsurgical Institute — Boynton Beach
  • Center for Excellence in Eye Care — Miami
  • East Florida Eye Institutue — Stuart
  • Abrams Eye Center — Stuart
  • International Eye Center — Tampa

Indiana

  • American Eye Institute — New Albany

Missouri

  • Comprehensive Eye Care — Washington

North Carolina

  • Charlotte Eye, Ear, Nose and Throat — Charlotte

Pennsylvania

  • Ophthalmic Research & Clinical Studies — Moon Twp

Tennessee

  • Chattanooga Eye Institute — Chattanooga

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2006-12
Est. Completion 2008-05
Phase Phase 3

Sponsor

Lantibio

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00599716

The ClinicalTrials.gov registry entry for NCT00599716 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 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lantibio, which has 1 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 Dry Eye Disease 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: NCT00599716 reports 10 study locations spanning 6 distinct geographic areas — top geographies include Florida, Indiana, Missouri. 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 NCT00599716 about?

NCT00599716 is a clinical study titled "Safety and Efficacy Assessment of Vismed® (Sodium Hyaluronate) for the Treatment of Dry Eye Syndrome". The study is designed to assess the safety and efficacy of Vismed®, a special eye drop containing sodium hyaluronate, in the treatment of dry eye syndrome. Vismed® is being compared to another eye drop, identical in composition except that it does not contain the active ingredient, sodium hyaluronat...

What is the current status of trial NCT00599716?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2006-12. Estimated completion is 2008-05.

What conditions does trial NCT00599716 study?

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

What interventions are being tested in trial NCT00599716?

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

Who is sponsoring clinical trial NCT00599716?

This trial is sponsored by Lantibio, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00599716 being conducted?

This trial has 10 study locations across Florida, Indiana, Missouri, North Carolina, 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