Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)

NCT04140227 · View on ClinicalTrials.gov ↗

Study Summary

The objectives of this trial are to evaluate the safety and tolerability of perfluorohexyloctane (NOV03) ophthalmic solution during long-term use in subjects with Dry Eye Disease (DED) associated with MGD (Meibomian Gland Dysfunction). Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during long-term use in subjects with DED associated with MGD.

Conditions Studied

Interventions

  • DRUG NOV03

Study Locations (20)

California

  • Bausch Site 110 — Glendale
  • Bausch Site 121 — Long Beach
  • Bausch Site 102 — Mission Hills
  • Bausch Site 101 — Newport Beach
  • Bausch Site 116 — Rancho Cordova
  • Bausch Site 103 — Torrance
  • Bausch Site 123 — Torrance

Florida

  • Bausch Site 129 — Fort Myers
  • Bausch Site 115 — Jacksonville
  • Bausch Site 106 — Largo
  • Bausch Site 117 — Tampa

Missouri

  • Bausch Site 113 — Kansas City
  • Bausch Site 111 — St Louis

Alabama

  • Bausch Site 124 — Birmingham

Arizona

  • Bausch Site 125 — Scottsdale

Connecticut

  • Bausch Site 127 — Danbury

Illinois

  • Bausch Site 108 — Lake Villa

Indiana

  • Bausch Site 112 — Indianapolis

Trial Details

FieldValue
Enrollment Target 256 participants
Start Date 2020-09-24
Est. Completion 2022-01-05
Phase Phase 3

Sponsor

Bausch & Lomb Incorporated

78 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04140227

The ClinicalTrials.gov registry entry for NCT04140227 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 256 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 1 condition, with Dry Eye Disease (DED) appearing as the primary indexed condition, and to 1 intervention — of which NOV03 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: NCT04140227 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, 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 NCT04140227 about?

NCT04140227 is a clinical study titled "Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)". The objectives of this trial are to evaluate the safety and tolerability of perfluorohexyloctane (NOV03) ophthalmic solution during long-term use in subjects with Dry Eye Disease (DED) associated with MGD (Meibomian Gland Dysfunction). Further objective is to evaluate the efficacy of perfluorohexyl...

What is the current status of trial NCT04140227?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 256 participants. The study started on 2020-09-24. Estimated completion is 2022-01-05.

What conditions does trial NCT04140227 study?

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

What interventions are being tested in trial NCT04140227?

The interventions under investigation include: NOV03 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04140227?

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 NCT04140227 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. 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