Trial Outcomes & Findings for Systemic Bioavailability Study Of Col-118 Administered Topically as a 0.18 % Facial Gel And Brimonidine Ophthalmic Solution 0.2% (NCT NCT00697541)
NCT ID: NCT00697541
Last Updated: 2021-02-18
Results Overview
Maximum observed plasma concentration
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dose
Results posted on
2021-02-18
Participant Flow
Participant milestones
| Measure |
Seq1-facial Gel+Saline Drops,Then Vehicle+Brimonidine Drops
One (1) gram of 0.18% COL-118 facial gel (1.8 mg brimonidine tartrate) administered topically plus 1 drop of Advanced Eye Relief™ (placebo ophthalmic solution) in each eye, once in the morning. One (1) gram of 0.18% COL-118 facial gel was to be reapplied once after 4 hours.
First intervention (1 day), washout (1 day), Second intervention (1 day)
|
Seq2-vehicle+Brimonidine Drops,Then Facial Gel+Saline Drops
One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically
First intervention (1 day), washout (1 day), Second intervention (1 day)
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Systemic Bioavailability Study Of Col-118 Administered Topically as a 0.18 % Facial Gel And Brimonidine Ophthalmic Solution 0.2%
Baseline characteristics by cohort
| Measure |
Seq1-facial Gel+Saline Drops,Then Vehicle+Brimonidine Drops
n=10 Participants
One (1) gram of 0.18% COL-118 facial gel (1.8 mg brimonidine tartrate) administered topically plus 1 drop of Advanced Eye Relief™ (placebo ophthalmic solution) in each eye, once in the morning. One (1) gram of 0.18% COL-118 facial gel was to be reapplied once after 4 hours.
First intervention (1 day), washout (1 day), Second intervention (1 day)
|
Seq2-vehicle+Brimonidine Drops,Then Facial Gel+Saline Drops
n=10 Participants
One 1-g application of COL-118 facial gel vehicle (0.0 mg brimonidine tartrate) administered topically plus one drop of 0.2% brimonidine ophthalmic solution (0.1 mg brimonidine tartrate/drop) in each eye. Four hours after the first application 1-g of COL-118 facial gel vehicle (0.0 mg brimonidine) is administered topically
First intervention (1 day), washout (1 day), Second intervention (1 day)
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
43.0 years
STANDARD_DEVIATION 8.5 • n=99 Participants
|
47.1 years
STANDARD_DEVIATION 6.7 • n=107 Participants
|
45.1 years
STANDARD_DEVIATION 7.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
20 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning doseMaximum observed plasma concentration
Outcome measures
| Measure |
Treatment A - COL-118 Facial Gel + Saline Drops
n=19 Participants
COL-118 facial gel + saline drops
|
Treatment B - Vehicle Gel + Brimonidine Drops
n=18 Participants
Vehicle gel + brimonidine drops
|
|---|---|---|
|
Cmax - Maximum Systemic Concentration of Brimonidine
|
NA pg/mL
Full Range NA
After application of Brimonidine 0.18% Gel, plasma levels of brimonidine for all subjects were below the limit of quantification (\< 25 pg/mL) with the exception of one single outlier value therefore no PK analysis could be performed.
|
NA pg/mL
Full Range NA • Interval to 100.0
The mean Cmax was not calculated because values were not quantifiable for 7 of 18 subjects.
|
PRIMARY outcome
Timeframe: 0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning doseArea under the plasma concentration-time curve from 0 hour to the last measurable plasma concentration, calculated by the linear trapezoidal method After two topical applications of 0.18% COL-118 facial gel, plasma levels of brimonidine for all subjects were below the LoQ (25 pg/mL), with the exception of one single outlier value. Thus, no PK analysis could be performed for 0.18% COL-118 facial gel. After ocular administration of 0.2% brimonidine tartrate ophthalmic solution, quantifiable plasma concentrations of brimonidine were observed in 11 of the 18 subjects who received the brimonidine tartrate ophthalmic solution. Brimonidine rapidly appeared in plasma The mean Cmax was not calculated because values were not quantifiable for 7 of 18 subjects The mean AUC0-t also was not calculated.
Outcome measures
| Measure |
Treatment A - COL-118 Facial Gel + Saline Drops
n=19 Participants
COL-118 facial gel + saline drops
|
Treatment B - Vehicle Gel + Brimonidine Drops
n=18 Participants
Vehicle gel + brimonidine drops
|
|---|---|---|
|
AUC - Area Under the Curve of Brimonidine
|
NA pg*hr/mL
Full Range NA
After application of Brimonidine 0.18% Gel, plasma levels of brimonidine for all subjects were below the limit of quantification (\< 25 pg/mL) with the exception of one single outlier value therefore no PK analysis could be performed.
|
NA pg*hr/mL
Full Range NA • Interval to 471.0
The mean AUC was not calculated because values were not quantifiable for 9 of 18 subjects
|
PRIMARY outcome
Timeframe: 0 Hour (prior to dose) and at 1, 2, 3, 4, 5, 6, 7, and 8 hours post-morning dosetime to maximum plasma concentration
Outcome measures
| Measure |
Treatment A - COL-118 Facial Gel + Saline Drops
n=19 Participants
COL-118 facial gel + saline drops
|
Treatment B - Vehicle Gel + Brimonidine Drops
n=18 Participants
Vehicle gel + brimonidine drops
|
|---|---|---|
|
Tmax - Time to Maximum Plasma Concentration
|
NA Hours
After application of Brimonidine 0.18% Gel, plasma levels of brimonidine for all subjects were below the limit of quantification (\< 25 pg/mL) with the exception of one single outlier value therefore no PK analysis could be performed.
|
NA Hours
Interval 0.933 to 4.07
After ocular administration of the 0.2% brimonidine tartrate ophthalmic solution, quantifiable plasma concentrations were observed in 11 of the 18 subjects, therefore Tmax Mean is NA.
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment B
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A
n=19 participants at risk
COL-118 gel + saline drops
|
Treatment B
n=18 participants at risk
Vehicle gel + brimonidine drops
|
|---|---|---|
|
Nervous system disorders
Headache
|
15.8%
3/19
|
27.8%
5/18
|
|
Nervous system disorders
Syncope
|
0.00%
0/19
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
pharyngolagyngeal pain
|
0.00%
0/19
|
5.6%
1/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60