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

Phase 3

Completed

• Conditions: Dry Eye Disease (DED)
• Interventions: Drug: NOV03; Drug: Placebo

• Registration Number: NCT04139798
• Lead Sponsor: Bausch & Lomb Incorporated

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-25
• Study Start: 2020-07-20
• Primary Completion: 2021-03-12
• Study Completion: 2021-03-12
• Disposition First Submitted: 2022-03-11
• Status Verified: 2024-08
• Results First Submitted: 2024-08-23
• Results First Submitted QC: 2024-10-01
• Last Update Submitted: 2024-10-01
• Results First Posted: 2024-10-23
• Disposition First Posted: 2024-10-23
• Last Update Posted: 2024-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 599

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NOV03 4 times daily (QID)	NOV03	100% Perfluorohexyloctance solution 4 times daily (QID)
Placebo 4 times daily (QID)	Placebo	Saline solution (0.6% sodium chloride solution) 4 times daily (QID)

Primary Outcome Measures

Name	Time	Method
Change From Baseline (CFB) in Total Corneal Fluorescein Staining (tCFS) at Day 57	Assessed from Baseline to 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.
Change From Baseline of Dryness Score at Day 57	Assessed from Baseline to 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).

Trial Locations

Locations (29)

Bausch Site 112; 🇺🇸 Indianapolis, Indiana, United States

103; 🇺🇸 Torrance, California, United States

Bausch Site 115; 🇺🇸 Jacksonville, Florida, United States

Bausch Site 108; 🇺🇸 Lake Villa, Illinois, United States

Bausch Site 122; 🇺🇸 Cranberry Township, Pennsylvania, United States

Bausch Site 102; 🇺🇸 Mission Hills, California, United States

Bausch Site 110; 🇺🇸 Glendale, California, United States

Bausch Site 104; 🇺🇸 Lakeway, Texas, United States

Bausch Site 107; 🇺🇸 Memphis, Tennessee, United States

Bausch Site 128; 🇺🇸 Slingerlands, New York, United States

Bausch Site 114; 🇺🇸 Raleigh, North Carolina, United States

Bausch Site 124; 🇺🇸 Birmingham, Alabama, United States

Bausch Site 125; 🇺🇸 Scottsdale, Arizona, United States

Bausch Site 101; 🇺🇸 Newport Beach, California, United States

Bausch Site 121; 🇺🇸 Long Beach, California, United States

Bausch Site 123; 🇺🇸 Torrance, California, United States

Bausch Site 127; 🇺🇸 Danbury, Connecticut, United States

Bausch Site 129; 🇺🇸 Fort Myers, Florida, United States

Bausch Site 106; 🇺🇸 Largo, Florida, United States

Bausch Site 117; 🇺🇸 Tampa, Florida, United States

Bausch Site 126; 🇺🇸 Winchester, Massachusetts, United States

Bausch Site 113; 🇺🇸 Kansas City, Missouri, United States

Bausch Site 119; 🇺🇸 Edgewood, Kentucky, United States

Bausch Site 111; 🇺🇸 Saint Louis, Missouri, United States

Bausch Site 120; 🇺🇸 El Paso, Texas, United States

Bausch Site 105; 🇺🇸 Round Rock, Texas, United States

Bausch Site 116; 🇺🇸 Rancho Cordova, California, United States

Bausch Site 109; 🇺🇸 Nashville, Tennessee, United States

Bausch Site 118; 🇺🇸 San Antonio, Texas, United States