A Phase 1/2 interventional study of LEV102 1.0% and LEV102 2.0% in Acquired Blepharoptosis, sponsored by Levation Pharma, Ltd.. Completed at 3 sites in United States. Open to participants aged 25 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-11-13.
Sponsored by Levation Pharma, Ltd. · Phase 1/2, Interventional, and Treatment
Phase 1/2a, multicenter, randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study conducted in adult subjects with acquired blepharoptosis.
This is a Phase 1/2a, multicenter, randomized, vehicle-controlled, double-masked, single-dose, parallel-group study conducted in adult subjects with acquired blepharoptosis. Subjects will receive a one-time application of randomized, double-masked IP. Approximately 30 subjects will be enrolled in this study. Eligible subjects will be randomized to 1 of the following 3 treatment groups in a 1:1:1 ratio and will receive a single dose of double-masked IP externally on the upper eyelid of both eyes (OU):
58 studies on the registry are indexed under Blepharoptosis; 16 are open to participants now.
This study's enrollment of 33 is below the median of 46 across 47 interventional studies indexed under Blepharoptosis.
Browse Blepharoptosis studies →This is the only study on the registry with Levation Pharma, Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Subjects who meet all the following inclusion criteria will be eligible to participate in the study. Subjects must:
Present with the following at Screening (Visit 1):
a. At least one eye that meets both of the following criteria: i. Margin Reflex Distance 1 MRD1 ≤2 mm (no visible central pupillary light reflex defaults to 0) ii. Current corrected VA, using subject's own prescription eyeglasses, if applicable, in the qualifying eye(s) of +0.3 LogMAR (Logarithm of the Minimum Angle of Resolution) or better as assessed by ETDRS b. Demonstrate upper eyelid elevation ≥0.5 mm change from baseline in MRD1 in both eyes in response to a single drop of oxymetazoline 0.1% ophthalmic solution)to each eye at Screening
Exclusion Criteria:
Drug: LEV102 2.0%
Drug: LEV102 1.0%
Drug: Vehicle
Oxymetazoline ophthalmic gel
Oxymetazoline ophthalmic gel
Vehicle ophthalmic gel
Percentage of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability])
Adverse events
Time frame: Day 2-5
Upper Eyelid Height
Percentage of subjects with increase in Margin reflex distance 1 (MRD1) of 1 mm at Hours 2 and 6 on Day 1
Time frame: Day 1
| Milestone | LEV102 Topical Gel, 2.0% | LEV102 Topical Gel, 1.0% | Vehicle |
|---|---|---|---|
| Started | 11 | 11 | 11 |
| Completed | 11 | 11 | 11 |
| Not completed | 0 | 0 | 0 |
Adverse events
| Participants | LEV102 Topical Gel, 2.0% | LEV102 Topical Gel, 1.0% | Vehicle |
|---|---|---|---|
| Percentage of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability]) | 0 | 0 | 0 |
Percentage of subjects with increase in Margin reflex distance 1 (MRD1) of 1 mm at Hours 2 and 6 on Day 1
| Participants | LEV102 Topical Gel, 2.0% | LEV102 Topical Gel, 1.0% | Vehicle |
|---|---|---|---|
| Upper Eyelid Height | 7 | 4 | 2 |
Collected over 2-5 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LEV102 Topical Gel, 2.0% | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| LEV102 Topical Gel, 1.0% | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Vehicle | 0/11 (0%) | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | LEV102 Topical Gel, 2.0% | LEV102 Topical Gel, 1.0% | Vehicle | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 4 | 4 | 15 |
| >=65 years | 4 | 7 | 7 | 18 |
| Age, Continuous(Years) | LEV102 Topical Gel, 2.0% | LEV102 Topical Gel, 1.0% | Vehicle | Total |
|---|---|---|---|---|
| Mean | 62.7 ± 10.3 | 66.3 ± 15.9 | 65.1 ± 11.2 | 64.7 ± 11.2 |
| Sex: Female, Male(Participants) | LEV102 Topical Gel, 2.0% | LEV102 Topical Gel, 1.0% | Vehicle | Total |
|---|---|---|---|---|
| Female | 9 | 8 | 8 | 25 |
| Male | 2 | 3 | 3 | 8 |
| Race (NIH/OMB)(Participants) | LEV102 Topical Gel, 2.0% | LEV102 Topical Gel, 1.0% | Vehicle | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 11 | 11 | 10 | 32 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | LEV102 Topical Gel, 2.0% | LEV102 Topical Gel, 1.0% | Vehicle | Total |
|---|---|---|---|---|
| United States | 11 | 11 | 11 | 33 |
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