Acquired Blepharoptosis
Conditions
Keywords
Blepharoptosis
Brief summary
Phase 1/2a, multicenter, randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study conducted in adult subjects with acquired blepharoptosis.
Detailed description
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):
Interventions
DRUGLEV102 1.0%
Oxymetazoline ophthalmic gel
DRUGLEV102 2.0%
Oxymetazoline ophthalmic gel
DRUGVehicle
Vehicle ophthalmic gel
Sponsors
Levation Pharma, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double masked
Intervention model description
Double-masked parallel
Eligibility
Sex/Gender
ALL
Age
25 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
Subjects who meet all the following inclusion criteria will be eligible to participate in the study. Subjects must: 1. Be male or female subjects 25 years of age or older at the time of Screening (Visit 1) 2. Have complaints of aesthetically unacceptable upper eyelid position for both eyes making them desirous for elevation, or have complaints of superior visual field defects in both eyes that impact activities of daily living 3. 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 4. Women of Childbearing Potential must agree to use an approved method of birth control from the date they sign the informed consent form (ICF) until after the last study visit (Follow-Up Visit) 5. Be able to give informed consent and willing to comply with all study visits and examinations
Exclusion criteria
1. Have any other ocular pathology other than ptosis requiring treatment with topical prescription ophthalmic drops in either eye (e.g., glaucoma, dry eye) 2. Have narrow angles, glaucoma, intraocular pressure \>23 mmHg or diagnosis of ocular hypertension, cup-to-disc ratio of \>0.7, or history of any glaucoma eye surgery in either eye 3. Have any active ocular or peri-ocular infection; any history of recurrent or chronic infection or inflammation in either eye 4. Have a history of allergic reaction to the investigational drug or any of its components 5. Within 7 days of Screening (Visit 1), or anticipated use during the study, use of any systemic, intranasal, topical dermatologic, or ophthalmic α-adrenergic agonist (including brimonidine) or antagonist including nasal or ocular or oral decongestants including pseudoephedrine, oxymetazoline topical ophthalmic solution, oxymetazoline topical dermatologic cream 6. Subjects who are pregnant or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability]) | Day 2-5 | Adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Upper Eyelid Height | Day 1 | Percentage of subjects with increase in Margin reflex distance 1 (MRD1) of 1 mm at Hours 2 and 6 on Day 1 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LEV102 Topical Gel, 2.0% LEV102 2.0%: Oxymetazoline ophthalmic gel | 11 |
| LEV102 Topical Gel, 1.0% LEV102 1.0%: Oxymetazoline ophthalmic gel | 11 |
| Vehicle Vehicle: Vehicle ophthalmic gel | 11 |
| Total | 33 |
Baseline characteristics
| Characteristic | Total | LEV102 Topical Gel, 2.0% | LEV102 Topical Gel, 1.0% | Vehicle |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 4 Participants | 7 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 7 Participants | 4 Participants | 4 Participants |
| Age, Continuous | 64.7 Years STANDARD_DEVIATION 11.2 | 62.7 Years STANDARD_DEVIATION 10.3 | 66.3 Years STANDARD_DEVIATION 15.9 | 65.1 Years STANDARD_DEVIATION 11.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 11 Participants | 11 Participants | 10 Participants |
| Region of Enrollment United States | 33 participants | 11 participants | 11 participants | 11 participants |
| Sex: Female, Male Female | 25 Participants | 9 Participants | 8 Participants | 8 Participants |
| Sex: Female, Male Male | 8 Participants | 2 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 | 0 / 11 |
Outcome results
Primary
Percentage of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability])
Adverse events
Time frame: Day 2-5
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LEV102 Topical Gel, 2.0% | Percentage of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability]) | 0 Participants |
| LEV102 Topical Gel, 1.0% | Percentage of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability]) | 0 Participants |
| Vehicle | Percentage of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability]) | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LEV102 Topical Gel, 2.0% | Upper Eyelid Height | 7 Participants |
| LEV102 Topical Gel, 1.0% | Upper Eyelid Height | 4 Participants |
| Vehicle | Upper Eyelid Height | 2 Participants |