Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)

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

This trial will evaluate 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: Dry Eye Disease (DED)
• Intervention / Treatment: Drug: NOV03; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 599
• Phase: Phase 3

Contacts and Locations

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 123
    • Torrance, California, United States, 90505
      • 103
  • 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
    • Round Rock, Texas, United States, 78681
      • Bausch Site 105
    • San Antonio, Texas, United States, 78229
      • Bausch Site 118

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

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
PLACEBO_COMPARATOR: Placebo 4 times daily (QID); Saline solution (0.6% sodium chloride solution) 4 times daily (QID)	Drug: Placebo; Saline solution (0.6% sodium chloride solution)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline (CFB) in total Corneal Fluorescein Staining (tCFS) at Day 57	Corneal Fluorescein Staining (tCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining, 3 corresponds to maximum staining. The total score is the sum of the 5 subregions ranging from 0-15.	Baseline to Day 57
CFB of Dryness Score at Day 57	Dryness Score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort).	Baseline to Day 57

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2020
• Primary Completion (ACTUAL): March 12, 2021
• Study Completion (ACTUAL): March 12, 2021

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 (ACTUAL): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eyelid Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Meibomian Gland Dysfunction
• Other Study ID Numbers: NVU-003 (Gobi)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No