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)
Overview
- Phase
- Phase 3
- Intervention
- NOV03
- Conditions
- Dry Eye Disease (DED)
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 599
- Locations
- 29
- Primary Endpoint
- Change From Baseline (CFB) in Total Corneal Fluorescein Staining (tCFS) at Day 57
- Status
- Completed
- Last Updated
- last year
Overview
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).
Investigators
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
Arms & Interventions
NOV03 4 times daily (QID)
100% Perfluorohexyloctance solution 4 times daily (QID)
Intervention: NOV03
Placebo 4 times daily (QID)
Saline solution (0.6% sodium chloride solution) 4 times daily (QID)
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline (CFB) in Total Corneal Fluorescein Staining (tCFS) at Day 57
Time Frame: 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
Time Frame: 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).