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

NCT04139798 | Completed Phase 3 Results FDA Drug

• 1 other identifier: NVU-003 (Gobi)
• Study Type: interventional
• Target: 599
• Locations: 1 country
• Sites: 29

Brief Summary

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).

Conditions

Dry Eye Disease (DED)

Outcome Measures

Primary Outcomes (2)

• 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.

  Assessed from Baseline to Day 57

• Change From Baseline 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).

  Assessed from Baseline to Day 57

Study Arms (2)

NOV03 4 times daily (QID)

EXPERIMENTAL

100% Perfluorohexyloctance solution 4 times daily (QID)

Drug: NOV03

Placebo 4 times daily (QID)

PLACEBO COMPARATOR

Saline solution (0.6% sodium chloride solution) 4 times daily (QID)

Drug: Placebo

Interventions

NOV03 DRUG

100% Perfluorohexyloctane

NOV03 4 times daily (QID)

Placebo DRUG

Saline solution (0.6% sodium chloride solution)

Placebo 4 times daily (QID)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (29)

Bausch Site 124

Birmingham, Alabama, 35233, United States

Location

Bausch Site 125

Scottsdale, Arizona, 85254, United States

Location

Bausch Site 110

Glendale, California, 91204, United States

Location

Bausch Site 121

Long Beach, California, 90805, United States

Location

Bausch Site 102

Mission Hills, California, 91345, United States

Location

Bausch Site 101

Newport Beach, California, 92663, United States

Location

Bausch Site 116

Rancho Cordova, California, 95670, United States

Location

103

Torrance, California, 90505, United States

Location

Bausch Site 123

Torrance, California, 90505, United States

Location

Bausch Site 127

Danbury, Connecticut, 06810, United States

Location

Bausch Site 129

Fort Myers, Florida, 33901, United States

Location

Bausch Site 115

Jacksonville, Florida, 32256, United States

Location

Bausch Site 106

Largo, Florida, 33773, United States

Location

Bausch Site 117

Tampa, Florida, 33603, United States

Location

Bausch Site 108

Lake Villa, Illinois, 60046, United States

Location

Bausch Site 112

Indianapolis, Indiana, 46260, United States

Location

Bausch Site 119

Edgewood, Kentucky, 41017, United States

Location

Bausch Site 126

Winchester, Massachusetts, 01890, United States

Location

Bausch Site 113

Kansas City, Missouri, 64111, United States

Location

Bausch Site 111

St Louis, Missouri, 63131, United States

Location

Bausch Site 128

Slingerlands, New York, 12159, United States

Location

Bausch Site 114

Raleigh, North Carolina, 27603, United States

Location

Bausch Site 122

Cranberry Township, Pennsylvania, 16066, United States

Location

Bausch Site 107

Memphis, Tennessee, 38119, United States

Location

Bausch Site 109

Nashville, Tennessee, 37205, United States

Location

Bausch Site 120

El Paso, Texas, 79902, United States

Location

Bausch Site 104

Lakeway, Texas, 78738, United States

Location

Bausch Site 105

Round Rock, Texas, 78681, United States

Location

Bausch Site 118

San Antonio, Texas, 78229, United States

Location

Related Publications (2)

• Fahmy AM, Harthan JS, Evans DG, Greiner JV, Tauber J, Sheppard JD, Krosser S, Vittitow JL. Perfluorohexyloctane ophthalmic solution for dry eye disease: pooled analysis of two phase 3 clinical trials. Front Ophthalmol (Lausanne). 2024 Nov 5;4:1452422. doi: 10.3389/fopht.2024.1452422. eCollection 2024.

  PMID: 39564145 DERIVED

• Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.

  PMID: 36729473 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Daniel Donatello
• Organization: Bausch & Lomb

Daniel.Donatello@bausch.com

5853385306

Study Officials

• Johnson Varughese

  Bausch Health

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: July 20, 2020
• Primary Completion: March 12, 2021
• Study Completion: March 12, 2021
• Last Updated: October 23, 2024
• Results First Posted: October 23, 2024

Record last verified: 2024-08

Locations

US (29)