Trial Outcomes & Findings for Safety, Efficacy and Pharmacokinetics of CBT-006 in Patients With Meibomian Gland Dysfunction (NCT NCT04884243)
NCT ID: NCT04884243
Last Updated: 2024-04-24
Results Overview
Intraocular Pressure of study eye related to safety
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
92 participants
Primary outcome timeframe
12 weeks
Results posted on
2024-04-24
Participant Flow
Participant milestones
| Measure |
CBT-006
Vehicle
CBT-006: ophthalmic solution
|
CBT-006 Lower Concentration
lower concentration dose
CBT-006: ophthalmic solution
|
CBT-006 Higher Concentration
higher concentration dose
CBT-006: ophthalmic solution
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
30
|
30
|
|
Overall Study
COMPLETED
|
32
|
29
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Efficacy and Pharmacokinetics of CBT-006 in Patients With Meibomian Gland Dysfunction
Baseline characteristics by cohort
| Measure |
CBT-006
n=32 Participants
Vehicle
CBT-006: ophthalmic solution
|
CBT-006 Lower Concentration
n=30 Participants
lower concentration dose
CBT-006: ophthalmic solution
|
CBT-006 Higher Concentration
n=30 Participants
higher concentration dose
CBT-006: ophthalmic solution
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
61 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
31 Participants
n=483 Participants
|
|
Age, Continuous
|
61.9 years
STANDARD_DEVIATION 6.98 • n=93 Participants
|
61.3 years
STANDARD_DEVIATION 11.75 • n=4 Participants
|
52.3 years
STANDARD_DEVIATION 13.23 • n=27 Participants
|
58.6 years
STANDARD_DEVIATION 11.65 • n=483 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
50 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
42 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
69 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
62 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=93 Participants
|
30 participants
n=4 Participants
|
30 participants
n=27 Participants
|
92 participants
n=483 Participants
|
|
Intraocular Pressure of study eye related to safety
|
16.328 mmHg
STANDARD_DEVIATION 2.1425 • n=93 Participants
|
16.517 mmHg
STANDARD_DEVIATION 2.5342 • n=4 Participants
|
16 mmHg
STANDARD_DEVIATION 2.6781 • n=27 Participants
|
16.282 mmHg
STANDARD_DEVIATION 0.21359 • n=483 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Safety Population Study eye
Intraocular Pressure of study eye related to safety
Outcome measures
| Measure |
CBT-006 Vehicle
n=32 Participants
Vehicle
CBT-006: ophthalmic solution
|
CBT-006 Lower Concentration
n=30 Participants
lower concentration dose
CBT-006: ophthalmic solution
|
CBT-006 Higher Concentration
n=30 Participants
higher concentration dose
CBT-006: ophthalmic solution
|
|---|---|---|---|
|
IOP of Study Eye Related to Safety
|
16.547 mmHg
Standard Deviation 2.0882
|
16.328 mmHg
Standard Deviation 2.6230
|
16.241 mmHg
Standard Deviation 2.6647
|
Adverse Events
CBT-006
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
CBT-006 Lower Concentration
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CBT-006 Higher Concentration
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CBT-006
n=32 participants at risk
Vehicle
CBT-006: ophthalmic solution
|
CBT-006 Lower Concentration
n=30 participants at risk
lower concentration dose
CBT-006: ophthalmic solution
|
CBT-006 Higher Concentration
n=30 participants at risk
higher concentration dose
CBT-006: ophthalmic solution
|
|---|---|---|---|
|
Eye disorders
ocular TEAEs
|
3.1%
1/32 • Number of events 1 • one year
|
6.7%
2/30 • Number of events 2 • one year
|
6.7%
2/30 • Number of events 2 • one year
|
|
General disorders
Non-ocular TEAEs
|
9.4%
3/32 • Number of events 3 • one year
|
3.3%
1/30 • Number of events 1 • one year
|
6.7%
2/30 • Number of events 2 • one year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place