Trial Outcomes & Findings for Open Label Extension of LipoLat-CS202 (NCT NCT02599688)
NCT ID: NCT02599688
Last Updated: 2020-12-14
Results Overview
Mean change from baseline (Visit 1 in Study LipoLat-CS202, NCT02466399) IOP at Month 3 (6 months after treatment in LipoLat-CS202).
Recruitment status
COMPLETED
Target enrollment
18 participants
Primary outcome timeframe
3 months
Results posted on
2020-12-14
Participant Flow
Participant milestones
| Measure |
Post Treatment Follow-up
Post treatment follow-up
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Post Treatment Follow-up
Post treatment follow-up
|
|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Termination by Sponsor
|
2
|
Baseline Characteristics
Open Label Extension of LipoLat-CS202
Baseline characteristics by cohort
| Measure |
Post Treatment Follow-up
n=18 Participants
Post treatment follow-up
|
|---|---|
|
Age, Continuous
|
61.7 years
STANDARD_DEVIATION 7.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Per protocol
Mean change from baseline (Visit 1 in Study LipoLat-CS202, NCT02466399) IOP at Month 3 (6 months after treatment in LipoLat-CS202).
Outcome measures
| Measure |
Post Treatment Follow-up
n=16 Participants
Post treatment follow-up
|
|---|---|
|
Intraocular Pressure (IOP)
|
-4.2 mm Hg
Standard Deviation 4.0
|
Adverse Events
Post Treatment Follow-up
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Post Treatment Follow-up
n=18 participants at risk
Post treatment follow-up
|
|---|---|
|
Infections and infestations
Infections and infestations
|
27.8%
5/18 • Number of events 7 • 3 months
|
|
Eye disorders
Musculoskeletal and connective tissue disorders
|
11.1%
2/18 • Number of events 3 • 3 months
|
|
Eye disorders
Conjunctival haemorrhage
|
27.8%
5/18 • Number of events 5 • 3 months
|
|
Eye disorders
Conjunctival hyperaemia
|
16.7%
3/18 • Number of events 3 • 3 months
|
|
Eye disorders
Foreign body sensation in eyes
|
11.1%
2/18 • Number of events 2 • 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If multi-center study publication not published within two (2) years after the completion of the Study at all sites, Investigator may publish the results of the Study obtained by Investigator with 60 days notice to Sponsor
- Publication restrictions are in place
Restriction type: OTHER