Trial Outcomes & Findings for CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension (NCT NCT04360174)
NCT ID: NCT04360174
Last Updated: 2024-10-01
Results Overview
All adverse events will be captured throughout the study
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
19 participants
Primary outcome timeframe
Through study completion, 6 months
Results posted on
2024-10-01
Participant Flow
Participant milestones
| Measure |
OTX-TIC-Cohort 1
15 µg (formulation1) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
|
OTX-TIC-Cohort 2
26 µg (formulation1) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
|
OTX-TIC-Cohort 3
15 µg (formulation 2) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
|
OTX-TIC-Cohort 4
5 µg (formulation 3) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
4
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
OTX-TIC-Cohort 1
n=5 Participants
15 µg (formulation1) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
|
OTX-TIC-Cohort 2
n=4 Participants
26 µg (formulation1) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
|
OTX-TIC-Cohort 3
n=5 Participants
15 µg (formulation 2) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
|
OTX-TIC-Cohort 4
n=5 Participants
5 µg (formulation 3) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=21 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
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (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
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
19 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Through study completion, 6 monthsAll adverse events will be captured throughout the study
Outcome measures
| Measure |
OTX-TIC-Cohort 1
n=5 Participants
15 µg (formulation1) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
|
OTX-TIC-Cohort 2
n=4 Participants
26 µg (formulation1) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
|
OTX-TIC-Cohort 3
n=5 Participants
15 µg (formulation 2) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
|
OTX-TIC-Cohort 4
n=5 Participants
5 µg (formulation 3) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
|
|---|---|---|---|---|
|
Ocular Treatment Emergent Adverse Events
|
9 Number of Treatment-Emergent Events
|
7 Number of Treatment-Emergent Events
|
9 Number of Treatment-Emergent Events
|
1 Number of Treatment-Emergent Events
|
PRIMARY outcome
Timeframe: Diurnal IOP [12 Week Visit]IOP measurements at 8 am
Outcome measures
| Measure |
OTX-TIC-Cohort 1
n=5 Participants
15 µg (formulation1) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
|
OTX-TIC-Cohort 2
n=4 Participants
26 µg (formulation1) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
|
OTX-TIC-Cohort 3
n=5 Participants
15 µg (formulation 2) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
|
OTX-TIC-Cohort 4
n=5 Participants
5 µg (formulation 3) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
|
|---|---|---|---|---|
|
Efficacy Outcome
|
-5.6 mmHg mean IOP change at wk12 from bln
Standard Deviation 2.58
|
-7.0 mmHg mean IOP change at wk12 from bln
Standard Deviation 3.27
|
-3.0 mmHg mean IOP change at wk12 from bln
Standard Deviation 14.4
|
-7.4 mmHg mean IOP change at wk12 from bln
Standard Deviation 4.76
|
Adverse Events
OTX-TIC-Cohort 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
OTX-TIC-Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
OTX-TIC-Cohort 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
OTX-TIC-Cohort 4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
OTX-TIC-Cohort 1
n=5 participants at risk
15 µg (formulation1) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
|
OTX-TIC-Cohort 2
n=4 participants at risk
26 µg (formulation1) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
|
OTX-TIC-Cohort 3
n=5 participants at risk
15 µg (formulation 2) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
|
OTX-TIC-Cohort 4
n=5 participants at risk
5 µg (formulation 3) implant
OTX-TIC: OTX-TIC implant is injection in the anterior chamber of the eye
|
|---|---|---|---|---|
|
Eye disorders
Congenital, familial and genetic disorders
|
20.0%
1/5 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/5 • 6 months
|
0.00%
0/5 • 6 months
|
|
Eye disorders
Eye Disorders
|
60.0%
3/5 • Number of events 8 • 6 months
|
50.0%
2/4 • Number of events 7 • 6 months
|
40.0%
2/5 • Number of events 3 • 6 months
|
20.0%
1/5 • Number of events 1 • 6 months
|
|
Eye disorders
Uncoded Terms
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
40.0%
2/5 • Number of events 3 • 6 months
|
0.00%
0/5 • 6 months
|
|
Eye disorders
Investigations
|
0.00%
0/5 • 6 months
|
0.00%
0/4 • 6 months
|
60.0%
3/5 • Number of events 3 • 6 months
|
0.00%
0/5 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60