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

Dry Eye Disease (DED) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04139798
• Other study ID #: NVU-003 (Gobi)
• Status: Completed
• Phase: Phase 3
• Start date: July 20, 2020
• Est. completion date: March 12, 2021

Study information

• Verified date: March 2022
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 599
• Est. completion date: March 12, 2021
• Est. primary completion date: March 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease (DED)
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction

Intervention

Drug:
• NOV03
100% Perfluorohexyloctane
• Placebo
Saline solution (0.6% sodium chloride solution)

Locations

Country	Name	City	State
United States	Bausch Site 124	Birmingham	Alabama
United States	Bausch Site 122	Cranberry Township	Pennsylvania
United States	Bausch Site 127	Danbury	Connecticut
United States	Bausch Site 119	Edgewood	Kentucky
United States	Bausch Site 120	El Paso	Texas
United States	Bausch Site 129	Fort Myers	Florida
United States	Bausch Site 110	Glendale	California
United States	Bausch Site 112	Indianapolis	Indiana
United States	Bausch Site 115	Jacksonville	Florida
United States	Bausch Site 113	Kansas City	Missouri
United States	Bausch Site 108	Lake Villa	Illinois
United States	Bausch Site 104	Lakeway	Texas
United States	Bausch Site 106	Largo	Florida
United States	Bausch Site 121	Long Beach	California
United States	Bausch Site 107	Memphis	Tennessee
United States	Bausch Site 102	Mission Hills	California
United States	Bausch Site 109	Nashville	Tennessee
United States	Bausch Site 101	Newport Beach	California
United States	Bausch Site 114	Raleigh	North Carolina
United States	Bausch Site 116	Rancho Cordova	California
United States	Bausch Site 105	Round Rock	Texas
United States	Bausch Site 111	Saint Louis	Missouri
United States	Bausch Site 118	San Antonio	Texas
United States	Bausch Site 125	Scottsdale	Arizona
United States	Bausch Site 128	Slingerlands	New York
United States	Bausch Site 117	Tampa	Florida
United States	103	Torrance	California
United States	Bausch Site 123	Torrance	California
United States	Bausch Site 126	Winchester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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