Dry Eye Disease (DED)
Conditions
Brief summary
The objectives of this trial are to evaluate the safety and tolerability of perfluorohexyloctane (NOV03) ophthalmic solution during long-term use in subjects with Dry Eye Disease (DED) associated with MGD (Meibomian Gland Dysfunction). Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during long-term use in subjects with DED associated with MGD.
Detailed description
The objectives of this trial are to evaluate the safety and tolerability of perfluorohexyloctane (NOV03) ophthalmic solution during long-term use in subjects with Dry Eye Disease (DED) associated with MGD (Meibomian Gland Dysfunction). Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during long-term use in subjects with DED associated with MGD.
Interventions
DRUGNOV03
100% Perfluorohexyloctane
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 |
|---|---|
| Number of Participants With Ocular and Non-ocular Adverse Events | 12 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single-arm Open Label single-arm open label | 208 |
| Total | 208 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 8 |
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Other | 3 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 26 |
Baseline characteristics
| Characteristic | Single-arm Open Label |
|---|---|
| Age, Continuous | 61.2 Years STANDARD_DEVIATION 13.02 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 29 Participants |
| Race (NIH/OMB) Black or African American | 43 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 133 Participants |
| Sex: Female, Male Female | 146 Participants |
| Sex: Female, Male Male | 62 Participants |
| Type of Eyes Left Eye | 87 Participants |
| Type of Eyes Right Eye | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 208 |
| other Total, other adverse events | 44 / 208 |
| serious Total, serious adverse events | 10 / 208 |
Outcome results
Primary
Number of Participants With Ocular and Non-ocular Adverse Events
Time frame: 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| NOV03 4 Times Daily (QID) | Number of Participants With Ocular and Non-ocular Adverse Events | At Least 1 TEAE Ocular and non-Ocular | 69 Participants |
| NOV03 4 Times Daily (QID) | Number of Participants With Ocular and Non-ocular Adverse Events | At Least 1 IP-related TEAE Ocular and non-Ocular | 14 Participants |
| NOV03 4 Times Daily (QID) | Number of Participants With Ocular and Non-ocular Adverse Events | At Least 1 SAE Ocular and non-Ocular | 1 Participants |
| NOV03 4 Times Daily (QID) | Number of Participants With Ocular and Non-ocular Adverse Events | TEAE that led to Drug Withdrawal | 9 Participants |