Dry Eye
Conditions
Brief summary
An Open-Label, Multicenter, Phase 4 Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease
Detailed description
The primary objective of this study is to evaluate early outcomes with Miebo treatment in subjects with Dry Eye Disease (DED)
Interventions
DRUGMiebo
Miebo® (perfluorohexyloctane ophthalmic solution) Dosage: one drop of MIEBO four times daily into each eye Dosage form: Ophthalmic solution: 100% perfluorohexyloctane. Frequency: 4 times daily for 14 days
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
1. At least 18 years of age at the time of consent 2. Able to provide written voluntary informed consent 3. The same eye must satisfy the below inclusion criteria (a-e): 1. Subject-reported history of DED in at least 1 eye for at least 6 months prior to Visit 1 2. Tear-film break-up time ≤5 seconds at Visit 1 3. Total corneal fluorescein staining score ≥4 and ≤11 (ie, sum of inferior, superior, central, nasal, and temporal) according to the National Eye Institute scale at Visit 1 4. Total meibomian gland dysfunction score ≥3 (range, 0-15) 5. Unanesthetized Schirmer's test I score ≥5 mm 4. Ocular Surface Disease Index (OSDI) ≥25 at Visit 1 5. Able and willing to follow instructions, including participation in all trial assessments and visits.
Exclusion criteria
Note: Ocular
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline (CFB) in Dry Eye Symptom Severity at Visit 3 | Change from baseline in VAS at Visit 3 (Day 7 ± 1 day) | Mean change from baseline (CFB) in dry eye symptom severity at Visit 3 (Day 7 ± 1 day) Scale name: Visual Analog Scale Range: min: 0%, max: 100%; 0% corresponds to none and 100% corresponds to worst severity possible Intrepretation: VAS is a subjective measurement tool that consists of a horizontal assessment line, of 100 mm (10 cm) length where patients place a vertical mark to indicate the level of perceived severity of symptoms. Higher values indicate worse disease severity, lower values indicate better outcome with treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Miebo Treatment Miebo: Miebo treatment | 99 |
| Total | 99 |
Baseline characteristics
| Characteristic | Miebo Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 43 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 90 Participants |
| Region of Enrollment United States | 99 participants |
| Sex: Female, Male Female | 85 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 99 |
| other Total, other adverse events | 0 / 99 |
| serious Total, serious adverse events | 0 / 99 |
Outcome results
Primary
Mean Change From Baseline (CFB) in Dry Eye Symptom Severity at Visit 3
Mean change from baseline (CFB) in dry eye symptom severity at Visit 3 (Day 7 ± 1 day) Scale name: Visual Analog Scale Range: min: 0%, max: 100%; 0% corresponds to none and 100% corresponds to worst severity possible Intrepretation: VAS is a subjective measurement tool that consists of a horizontal assessment line, of 100 mm (10 cm) length where patients place a vertical mark to indicate the level of perceived severity of symptoms. Higher values indicate worse disease severity, lower values indicate better outcome with treatment
Time frame: Change from baseline in VAS at Visit 3 (Day 7 ± 1 day)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Miebo Treatment | Mean Change From Baseline (CFB) in Dry Eye Symptom Severity at Visit 3 | -44.5 score on a scale | Standard Deviation 25.15 |