Trial Outcomes & Findings for A Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/Keratometry and Postoperative Refractive Accuracy (NCT NCT06346340)
NCT ID: NCT06346340
Last Updated: 2026-07-06
Results Overview
Mean difference between absolute deviations from predicted refractive error in the study eye at Visit 3 (Second Eye/Unilateral Postop Day 30 ± 7 days).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
97 participants
Primary outcome timeframe
Assessed at Postop Day 30 ± 7 days
Results posted on
2026-07-06
Participant Flow
Participant milestones
| Measure |
Miebo Treatment
Miebo: Miebo applied in both eyes 4 times per day for approximately 30 days before cataract surgery. Following the completion of the standard follow up, approximately 30 days after cataract surgery, subjects will begin a second regimen of Miebo , 4 times per day in both eyes, for approximately 30 days.
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|---|---|
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Overall Study
STARTED
|
97
|
|
Overall Study
COMPLETED
|
85
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Effect of Miebo™ on Preoperative Biometry/Keratometry and Postoperative Refractive Accuracy
Baseline characteristics by cohort
| Measure |
Miebo Treatment
n=97 Participants
Miebo: Miebo applied in both eyes 4 times per day for approximately 30 days before cataract surgery. Following the completion of the standard follow up, approximately 30 days after cataract surgery, subjects will begin a second regimen of Miebo , 4 times per day in both eyes, for approximately 30 days.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
72 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
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Region of Enrollment
United States
|
97 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Assessed at Postop Day 30 ± 7 daysMean difference between absolute deviations from predicted refractive error in the study eye at Visit 3 (Second Eye/Unilateral Postop Day 30 ± 7 days).
Outcome measures
| Measure |
Miebo Treatment
n=86 Participants
Miebo: Miebo applied in both eyes 4 times per day for approximately 30 days before cataract surgery. Following the completion of the standard follow up, approximately 30 days after cataract surgery, subjects will begin a second regimen of Miebo , 4 times per day in both eyes, for approximately 30 days.
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|---|---|
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Mean Difference Between Absolute Deviations From Predicted Refractive Error in the Study Eye.
|
-0.027 Diopters
Standard Deviation 0.167
|
Adverse Events
Miebo Treatment
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Miebo Treatment
n=97 participants at risk
Miebo: Miebo applied in both eyes 4 times per day for approximately 30 days before cataract surgery. Following the completion of the standard follow up, approximately 30 days after cataract surgery, subjects will begin a second regimen of Miebo , 4 times per day in both eyes, for approximately 30 days.
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|---|---|
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Eye disorders
Iridocele
|
1.0%
1/97 • Assessed for 118 days
|
|
Infections and infestations
Pneumonia
|
1.0%
1/97 • Assessed for 118 days
|
Other adverse events
| Measure |
Miebo Treatment
n=97 participants at risk
Miebo: Miebo applied in both eyes 4 times per day for approximately 30 days before cataract surgery. Following the completion of the standard follow up, approximately 30 days after cataract surgery, subjects will begin a second regimen of Miebo , 4 times per day in both eyes, for approximately 30 days.
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|---|---|
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Eye disorders
Intraocular pressure increased
|
5.2%
5/97 • Assessed for 118 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place