Trial Outcomes & Findings for LEV102 Topical Gel in Acquired Blepharoptosis (NCT NCT05715346)
NCT ID: NCT05715346
Last Updated: 2024-11-13
Results Overview
Adverse events
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Day 2-5
Results posted on
2024-11-13
Participant Flow
Participant milestones
| Measure |
LEV102 Topical Gel, 2.0%
LEV102 2.0%: Oxymetazoline ophthalmic gel
|
LEV102 Topical Gel, 1.0%
LEV102 1.0%: Oxymetazoline ophthalmic gel
|
Vehicle
Vehicle: Vehicle ophthalmic gel
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LEV102 Topical Gel in Acquired Blepharoptosis
Baseline characteristics by cohort
| Measure |
LEV102 Topical Gel, 2.0%
n=11 Participants
LEV102 2.0%: Oxymetazoline ophthalmic gel
|
LEV102 Topical Gel, 1.0%
n=11 Participants
LEV102 1.0%: Oxymetazoline ophthalmic gel
|
Vehicle
n=11 Participants
Vehicle: Vehicle ophthalmic gel
|
Total
n=33 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
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Age, Continuous
|
62.7 Years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
66.3 Years
STANDARD_DEVIATION 15.9 • n=107 Participants
|
65.1 Years
STANDARD_DEVIATION 11.2 • n=206 Participants
|
64.7 Years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
11 participants
n=107 Participants
|
11 participants
n=206 Participants
|
33 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Day 2-5Adverse events
Outcome measures
| Measure |
LEV102 Topical Gel, 2.0%
n=11 Participants
LEV102 2.0%: Oxymetazoline ophthalmic gel
|
LEV102 Topical Gel, 1.0%
n=11 Participants
LEV102 1.0%: Oxymetazoline ophthalmic gel
|
Vehicle
n=11 Participants
Vehicle: Vehicle ophthalmic gel
|
|---|---|---|---|
|
Percentage of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability])
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1Percentage of subjects with increase in Margin reflex distance 1 (MRD1) of 1 mm at Hours 2 and 6 on Day 1
Outcome measures
| Measure |
LEV102 Topical Gel, 2.0%
n=11 Participants
LEV102 2.0%: Oxymetazoline ophthalmic gel
|
LEV102 Topical Gel, 1.0%
n=11 Participants
LEV102 1.0%: Oxymetazoline ophthalmic gel
|
Vehicle
n=11 Participants
Vehicle: Vehicle ophthalmic gel
|
|---|---|---|---|
|
Upper Eyelid Height
|
7 Participants
|
4 Participants
|
2 Participants
|
Adverse Events
LEV102 Topical Gel, 2.0%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LEV102 Topical Gel, 1.0%
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI to collegially coordinate presentations and papers with Sponsor's scientists.
- Publication restrictions are in place
Restriction type: OTHER