LEV102 Topical Gel in Acquired Blepharoptosis

Study Overview
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Brief Summary
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Phase 1/2a, multicenter, randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study conducted in adult subjects with acquired blepharoptosis.

Detailed Description
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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):

Official Title
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A Phase 1/2a Study of LEV102 Topical Gel in Subjects With Acquired Blepharoptosis

Conditions
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Acquired Blepharoptosis

Intervention / Treatment
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* Drug: LEV102 1.0%
* Drug: LEV102 2.0%
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who meet all the following inclusion criteria will be eligible to participate in the study. Subjects must: Be male or female subjects 25 years of age or older at the time of Screening (Visit 1) 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 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 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) Be able to give informed consent and willing to comply with all study visits and examinations Exclusion Criteria: Have any other ocular pathology other than ptosis requiring treatment with topical prescription ophthalmic drops in either eye (e.g., glaucoma, dry eye) 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 Have any active ocular or peri-ocular infection; any history of recurrent or chronic infection or inflammation in either eye Have a history of allergic reaction to the investigational drug or any of its components 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 Subjects who are pregnant or breast-feeding

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-masked parallel
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LEV102 Topical Gel, 2.0%<br> | Drug: LEV102 2.0%<br>* Oxymetazoline ophthalmic gel<br>|
| Experimental: LEV102 Topical Gel, 1.0%<br> | Drug: LEV102 1.0%<br>* Oxymetazoline ophthalmic gel<br>|
| Placebo Comparator: Vehicle<br> | Drug: Vehicle<br>* Vehicle ophthalmic gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) | Adverse events | Day 2-5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper eyelid height | Margin reflex distance 1 | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blepharoptosis