Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study)

May 4, 2022 updated by: Bausch & Lomb Incorporated

A Phase 3, Multi-Center, Randomized, Double-Masked, Saline-Controlled Trial to Evaluate the Effect of NOV03 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Mojave Study)

The objectives of this trial are to assess the efficacy, safety, and tolerability of NOV03 ophthalmic solution in comparison to a saline control for the treatment of the signs and symptoms of Dry Eye Disease (DED) associated with Meibomian Gland Dysfunction (MGD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

622

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
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Bausch Site 206
    • California
      • Garden Grove, California, United States, 92843
        • Bausch Site 202
      • Hemet, California, United States, 92545
        • Bausch Site 221
      • Inglewood, California, United States, 90301
        • Bausch Site 214
      • Murrieta, California, United States, 92562
        • Bausch Site 226
      • Santa Ana, California, United States, 92705
        • Bausch Site 213
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Bausch Site 211
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Bausch Site 209
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Bausch Site 230
    • Kentucky
      • Louisville, Kentucky, United States, 40220
        • Bausch Site 207
    • Maryland
      • Havre De Grace, Maryland, United States, 21078
        • Bausch Site 228
    • Minnesota
      • Bloomington, Minnesota, United States, 55431
        • Bausch Site 231
    • Missouri
      • Saint Louis, Missouri, United States, 63128
        • Bausch Site 229
      • Saint Louis, Missouri, United States, 63131
        • Bausch Site 224
      • Washington, Missouri, United States, 63090
        • Bausch Site 217
    • New York
      • New York, New York, United States, 10013
        • Bausch Site 205
      • Rochester, New York, United States, 14618
        • Bausch Site 208
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Bausch Site 210
    • Ohio
      • Cincinnati, Ohio, United States, 45247
        • Bausch Site 201
      • Cleveland, Ohio, United States, 44115
        • Bausch Site 216
      • Columbus, Ohio, United States, 43215
        • Bausch Site 223
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Bausch Site 215
    • Texas
      • Cedar Park, Texas, United States, 78613
        • Bausch Site 219
      • League City, Texas, United States, 77573
        • Bausch Site 212
      • San Antonio, Texas, United States, 78213
        • Bausch Site 203
      • San Antonio, Texas, United States, 78215
        • Bausch Site 222
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Bausch Site 220
    • Washington
      • Seattle, Washington, United States, 98119
        • Bausch Site 227

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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 and Visit 1
  • 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NOV03
100% perfluorohexyloctane 4 times daily (QID)
Drug: NOV03
100% perfluorohexyloctane
Placebo Comparator: Saline solution
0.6% sodium chloride solution 4 times daily (QID)
Drug: Saline Solution
0.6% sodium chloride solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 57
Time Frame: Baseline, Day 57
The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total score of 15 points (sum of scores for each section).
Baseline, Day 57
Change from baseline in Dryness Score (visual analogue scale [VAS] Severity of Dryness) at Day 57
Time Frame: Baseline, Day 57
Study staff will ask participants to rate their severity of ocular dryness (both eyes simultaneously) by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no dryness" and 100% corresponds to "maximal dryness").
Baseline, Day 57

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Dryness Score (visual analogue scale [VAS] Severity of Dryness) at Day 15
Time Frame: Baseline, Day 15
Study staff will ask participants to rate their severity of ocular dryness (both eyes simultaneously) by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no dryness" and 100% corresponds to "maximal dryness").
Baseline, Day 15
Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 15
Time Frame: Baseline, Day 15
The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total of 15 points (sum of scores for each section).
Baseline, Day 15
Change from baseline in burning/stinging (visual analogue scale [VAS] Severity of Burning/Stinging) at Day 57
Time Frame: Baseline, Day 57
Subjects will be asked about the severity of burning / stinging. Study staff will ask subjects to rate their ocular symptoms (both eyes simultaneously) due to ocular dryness by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no discomfort" and 100% corresponds to "maximal discomfort").
Baseline, Day 57
Change from baseline in central Corneal Fluorescein Staining (NEI scale) at Day 57
Time Frame: Baseline, Day 57
The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum of 3 points in the central section.
Baseline, Day 57

Collaborators and Investigators

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

Sponsor

Bausch & Lomb Incorporated

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)

November 18, 2020

Primary Completion (Actual)

August 30, 2021

Study Completion (Actual)

August 30, 2021

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

September 23, 2020

First Posted (Actual)

September 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 11, 2022

Last Update Submitted That Met QC Criteria

May 4, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 904

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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