Trial Outcomes & Findings for Safety, Efficacy and Pharmacokinetics of CBT-008 in Patients With Meibomian Gland Dysfunction (NCT NCT05261386)
NCT ID: NCT05261386
Last Updated: 2024-04-24
Results Overview
Intraocular Pressure for study eye
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
95 participants
Primary outcome timeframe
4 weeks
Results posted on
2024-04-24
Participant Flow
Participant milestones
| Measure |
CBT-008 Vehicle
Vehicle CBT-008: ophthalmic solution
|
Experimental: Lower Concentration CBT-008
lower concentration CBT-008 ophthalmic solution
|
Experimental: Higher Concentration CBT-008 CBT-008
Higher concentration CBT-008 ophthalmic solution. CBT-008
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
32
|
|
Overall Study
COMPLETED
|
32
|
30
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Efficacy and Pharmacokinetics of CBT-008 in Patients With Meibomian Gland Dysfunction
Baseline characteristics by cohort
| Measure |
CBT-008 Vehicle
n=32 Participants
Vehicle
CBT-008: ophthalmic solution
|
CBT-008 Lower Concentration Ophthalmic Solution
n=31 Participants
lower concentration dose
CBT-008: ophthalmic solution
|
CBT-008 Higher Concentration Ophthalmic Solution
n=32 Participants
higher concentration dose
CBT-008: ophthalmic solution
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 15.67 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 10.75 • n=7 Participants
|
62.6 years
STANDARD_DEVIATION 13.80 • n=5 Participants
|
60.2 years
STANDARD_DEVIATION 13.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
31 participants
n=7 Participants
|
32 participants
n=5 Participants
|
95 participants
n=4 Participants
|
|
Intraocular Pressure of study eye related to safety
|
15.844 mmHg
STANDARD_DEVIATION 2.9415 • n=5 Participants
|
16.371 mmHg
STANDARD_DEVIATION 2.1015 • n=7 Participants
|
16.078 mmHg
STANDARD_DEVIATION 2.3352 • n=5 Participants
|
16.098 mmHg
STANDARD_DEVIATION 0,2156 • n=4 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Safety Population Study eye
Intraocular Pressure for study eye
Outcome measures
| Measure |
CBT-008 Ophthalmic Solution
n=32 Participants
Vehicle
CBT-008: ophthalmic solution
|
CBT-008 Lower Concentration
n=31 Participants
CBT-008 ophthalmic solution lower concentration dose
|
CBT-008 Higher Concentration
n=32 Participants
higher concentration dose CBT-008 ophthalmic solution
|
|---|---|---|---|
|
IOP Related to Safety
|
15.906 mmHg
Standard Deviation 3.0860
|
16.452 mmHg
Standard Deviation 2.6999
|
16.469 mmHg
Standard Deviation 2.2823
|
Adverse Events
Vehicle
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CBT-008 Ophthalmic Solution Single Dose
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
CBT-008 Ophthalmic Solution Multi-dose
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vehicle
n=32 participants at risk
One drop in the study administered three times daily (TID)
Vehicle: One drop in the study administered three times daily (TID) for 4 weeks
|
CBT-008 Ophthalmic Solution Single Dose
n=31 participants at risk
One drop in the study administered three times daily (TID)
CBT-008: One drop in the study administered three times daily (TID) for 4 weeks
|
CBT-008 Ophthalmic Solution Multi-dose
n=32 participants at risk
One drop in the study administered three times daily (TID)
CBT-008: One drop in the study administered three times daily (TID) for 4 weeks
|
|---|---|---|---|
|
General disorders
Non-ocular TEAEs
|
0.00%
0/32 • 6 months
|
3.2%
1/31 • 6 months
|
6.2%
2/32 • 6 months
|
|
Eye disorders
Ocular TEAEs
|
9.4%
3/32 • Number of events 3 • 6 months
|
12.9%
4/31 • 6 months
|
18.8%
6/32 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place