Clinical trial NCT04139798: Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease (DED)
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2019-10-25
Enrollment: 599
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline (CFB) in Total Corneal Fluorescein Staining (tCFS) at Day 57
timeFrame: Assessed from Baseline to Day 57
measure: Change From Baseline of Dryness Score at Day 57
timeFrame: Assessed from Baseline to Day 57
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Bausch Site 124
state: Alabama
city: Scottsdale
country: United States
facility: Bausch Site 125
state: Arizona
city: Glendale
country: United States
facility: Bausch Site 110
state: California
city: Long Beach
country: United States
facility: Bausch Site 121
state: California
city: Mission Hills
country: United States
facility: Bausch Site 102
state: California
city: Newport Beach
country: United States
facility: Bausch Site 101
state: California
city: Rancho Cordova
country: United States
facility: Bausch Site 116
state: California
city: Torrance
country: United States
facility: 103
state: California
city: Torrance
country: United States
facility: Bausch Site 123
state: California
city: Danbury
country: United States
facility: Bausch Site 127
state: Connecticut
city: Fort Myers
country: United States
facility: Bausch Site 129
state: Florida
city: Jacksonville
country: United States
facility: Bausch Site 115
state: Florida
city: Largo
country: United States
facility: Bausch Site 106
state: Florida
city: Tampa
country: United States
facility: Bausch Site 117
state: Florida
city: Lake Villa
country: United States
facility: Bausch Site 108
state: Illinois
city: Indianapolis
country: United States
facility: Bausch Site 112
state: Indiana
city: Edgewood
country: United States
facility: Bausch Site 119
state: Kentucky
city: Winchester
country: United States
facility: Bausch Site 126
state: Massachusetts
city: Kansas City
country: United States
facility: Bausch Site 113
state: Missouri
city: Saint Louis
country: United States
facility: Bausch Site 111
state: Missouri
city: Slingerlands
country: United States
facility: Bausch Site 128
state: New York
city: Raleigh
country: United States
facility: Bausch Site 114
state: North Carolina
city: Cranberry Township
country: United States
facility: Bausch Site 122
state: Pennsylvania
city: Memphis
country: United States
facility: Bausch Site 107
state: Tennessee
city: Nashville
country: United States
facility: Bausch Site 109
state: Tennessee
city: El Paso
country: United States
facility: Bausch Site 120
state: Texas
city: Lakeway
country: United States
facility: Bausch Site 104
state: Texas
city: Round Rock
country: United States
facility: Bausch Site 105
state: Texas
city: San Antonio
country: United States
facility: Bausch Site 118
state: Texas
Study officials:
affiliation: Bausch Health
name: Johnson Varughese
role: STUDY_DIRECTOR
References: