Trial Outcomes & Findings for A Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease (NCT NCT06309953)
NCT ID: NCT06309953
Last Updated: 2025-10-21
Results Overview
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
COMPLETED
PHASE4
99 participants
Change from baseline in VAS at Visit 3 (Day 7 ± 1 day)
2025-10-21
Participant Flow
Participant milestones
| Measure |
Miebo Treatment
Intervention: 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
|
|---|---|
|
Overall Study
STARTED
|
99
|
|
Overall Study
COMPLETED
|
98
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate Early Treatment Outcomes With Miebo™ in Subjects With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
Miebo Treatment
n=99 Participants
Miebo: Miebo treatment
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
90 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
99 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Miebo Treatment
n=99 Participants
Miebo: 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
|
Adverse Events
Miebo Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place