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

February 29, 2024 updated by: Bausch & Lomb Incorporated

A Phase 3, Multi-Center, Open-Label, Single-Arm Extension Clinical Trial to Assess the Extended 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 perfluorohexyloctane (NOV03) solution during long-term use in subjects with DED associated with MGD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Bausch Site 124
    • Arizona
      • Scottsdale, Arizona, United States, 85254
        • Bausch Site 125
    • California
      • Glendale, California, United States, 91204
        • Bausch Site 110
      • Long Beach, California, United States, 90805
        • Bausch Site 121
      • Mission Hills, California, United States, 91345
        • Bausch Site 102
      • Newport Beach, California, United States, 92663
        • Bausch Site 101
      • Rancho Cordova, California, United States, 95670
        • Bausch Site 116
      • Torrance, California, United States, 90505
        • Bausch Site 103
      • Torrance, California, United States, 90505
        • Bausch Site 123
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Bausch Site 127
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Bausch Site 129
      • Jacksonville, Florida, United States, 32256
        • Bausch Site 115
      • Largo, Florida, United States, 33773
        • Bausch Site 106
      • Tampa, Florida, United States, 33603
        • Bausch Site 117
    • Illinois
      • Lake Villa, Illinois, United States, 60046
        • Bausch Site 108
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Bausch Site 112
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Bausch Site 119
    • Massachusetts
      • Winchester, Massachusetts, United States, 01890
        • Bausch Site 126
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Bausch Site 113
      • Saint Louis, Missouri, United States, 63131
        • Bausch Site 111
    • New York
      • Slingerlands, New York, United States, 12159
        • Bausch Site 128
    • North Carolina
      • Raleigh, North Carolina, United States, 27603
        • Bausch Site 114
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Bausch Site 122
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Bausch Site 107
      • Nashville, Tennessee, United States, 37205
        • Bausch Site 109
    • Texas
      • El Paso, Texas, United States, 79902
        • Bausch Site 120
      • Lakeway, Texas, United States, 78738
        • Bausch Site 104
      • San Antonio, Texas, United States, 78229
        • Bausch Site 118

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed ICF (Informed Consent Form)
  • Subject-reported history of Drye Eye Disease (DED) in both eyes
  • Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

  • Women who are pregnant, nursing or planning pregnancy
  • Unwillingness to submit a blood pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
  • Clinically significant slit-lamp findings or abnormal lid anatomy at screening
  • Ocular/peri-ocular malignancy
  • History of herpetic keratitis
  • Active ocular allergies or ocular allergies that are expected to be active during the study
  • Ongoing ocular or systemic infection
  • Wear contact lenses within 1 month prior to screening or anticipated use of contact lenses during the study
  • Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have planned ocular and/or lid surgeries over the study period
  • Presence of uncontrolled systemic diseases
  • Presence of known allergy and/or sensitivity to the study drug or saline components
  • Use of any topical steroids treatments, topical cyclosporine, lifitegrast, serum tears or topical anti-glaucoma medication within 2 months prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NOV03 4 times daily (QID)
100% Perfluorohexyloctance solution 4 times daily (QID)
Drug: NOV03
100% Perfluorohexyloctane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Ocular and Non-ocular Adverse Events
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Study Director: Johnson Varughese, Bausch Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2020

Primary Completion (Actual)

January 5, 2022

Study Completion (Actual)

January 5, 2022

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

October 23, 2019

First Posted (Actual)

October 25, 2019

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NVU-004 (Kalahari)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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