Dry Eye Disease (DED)
Conditions
Brief summary
This study will evaluate the efficacy, safety and tolerability of perfluorohexyloctane (NOV03) at two different dosing regimens compared to saline solution in subjects with Dry Eye Disease (DED).
Interventions
DRUGNOV03
Perfluorohexyloctane
DRUGPlacebo
Saline solution (0.9% sodium chloride solution)
Sponsors
Novaliq GmbH
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 * 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 |
|---|---|---|
| Corneal Fluorescein Staining (CFS) Total (National Eye Institute (NEI) Grading) | baseline and 2 months | The primary efficacy variable was comparison of absolute and change from baseline between treatments for total Corneal Fluorescein Staining (tCFS) according to the National Eye Institute grading (NEI Scale) at week 8 The NEI Scale is a standardized grading system. 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NOV03 2 Times Daily (BID) Perfluorohexyloctance solution 2 times daily (BID)
NOV03: Perfluorohexyloctane | 111 |
| NOV03 4 Times Daily (QID) Perfluorohexyloctance solution 4 times daily
NOV03: Perfluorohexyloctane | 114 |
| Placebo BID/QID Saline solution (0.9% sodium chloride solution) 2/4 times daily (BID/QID)
Placebo: Saline solution (0.9% sodium chloride solution) | 111 |
| Total | 336 |
Baseline characteristics
| Characteristic | NOV03 2 Times Daily (BID) | Total | Placebo BID/QID | NOV03 4 Times Daily (QID) |
|---|---|---|---|---|
| Age, Continuous | 54.0 years | 53.6 years | 53.8 years | 53.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 26 Participants | 77 Participants | 21 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 85 Participants | 259 Participants | 90 Participants | 84 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 20 Participants | 59 Participants | 21 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 34 Participants | 8 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 78 Participants | 239 Participants | 81 Participants | 80 Participants |
| Region of Enrollment United States | 111 participants | 336 participants | 111 participants | 114 participants |
| Sex: Female, Male Female | 84 Participants | 243 Participants | 80 Participants | 79 Participants |
| Sex: Female, Male Male | 27 Participants | 93 Participants | 31 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 111 | 0 / 114 | 0 / 111 |
| other Total, other adverse events | 1 / 111 | 4 / 114 | 3 / 111 |
| serious Total, serious adverse events | 1 / 111 | 3 / 114 | 0 / 111 |
Outcome results
Primary
Corneal Fluorescein Staining (CFS) Total (National Eye Institute (NEI) Grading)
The primary efficacy variable was comparison of absolute and change from baseline between treatments for total Corneal Fluorescein Staining (tCFS) according to the National Eye Institute grading (NEI Scale) at week 8 The NEI Scale is a standardized grading system. 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage.
Time frame: baseline and 2 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| NOV03 2 Times Daily (BID) | Corneal Fluorescein Staining (CFS) Total (National Eye Institute (NEI) Grading) | -1.78 score on a scale |
| NOV03 4 Times Daily (QID) | Corneal Fluorescein Staining (CFS) Total (National Eye Institute (NEI) Grading) | -2.11 score on a scale |
| Placebo BID/QID | Corneal Fluorescein Staining (CFS) Total (National Eye Institute (NEI) Grading) | -0.93 score on a scale |