Dry Eye Disease (DED)
Conditions
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).
Interventions
DRUGNOV03
100% Perfluorohexyloctane
DRUGPlacebo
Saline solution (0.6% sodium chloride solution)
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NOV03 4 Times Daily (QID) 100% Perfluorohexyloctance solution 4 times daily (QID)
NOV03: 100% Perfluorohexyloctane | 303 |
| Placebo 4 Times Daily (QID) Saline solution (0.6% sodium chloride solution) 4 times daily (QID)
Placebo: Saline solution (0.6% sodium chloride solution) | 294 |
| Total | 597 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 3 |
| Overall Study | Discontinued | 4 | 2 |
| Overall Study | Lost to Follow-up | 2 | 5 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 5 |
Baseline characteristics
| Characteristic | NOV03 4 Times Daily (QID) | Placebo 4 Times Daily (QID) | Total |
|---|---|---|---|
| Age, Continuous | 60.3 years STANDARD_DEVIATION 14.23 | 61.6 years STANDARD_DEVIATION 13.57 | 60.9 years STANDARD_DEVIATION 13.91 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants | 51 Participants | 94 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 260 Participants | 243 Participants | 503 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 219 Participants | 214 Participants | 433 Participants |
| Sex: Female, Male Male | 84 Participants | 80 Participants | 164 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 303 | 0 / 294 |
| other Total, other adverse events | 16 / 303 | 11 / 294 |
| serious Total, serious adverse events | 0 / 303 | 0 / 294 |
Outcome results
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.
Time frame: Assessed from Baseline to Day 57
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NOV03 4 Times Daily (QID) | Change From Baseline (CFB) in Total Corneal Fluorescein Staining (tCFS) at Day 57 | -2.0 units on a scale | Standard Deviation 2.6 |
| Placebo 4 Times Daily (QID) | Change From Baseline (CFB) in Total Corneal Fluorescein Staining (tCFS) at Day 57 | -1.0 units on a scale | Standard Deviation 2.7 |
Primary
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).
Time frame: Assessed from Baseline to Day 57
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NOV03 4 Times Daily (QID) | Change From Baseline of Dryness Score at Day 57 | -27.4 units on a scale | Standard Deviation 27.9 |
| Placebo 4 Times Daily (QID) | Change From Baseline of Dryness Score at Day 57 | -19.7 units on a scale | Standard Deviation 26.7 |