LEV102 Topical Gel in Acquired Blepharoptosis

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

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

Study Overview

• Status: Completed
• Conditions: Acquired Blepharoptosis
• Intervention / Treatment: Drug: LEV102 2.0%; Drug: LEV102 1.0%; Drug: Vehicle

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):

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
    • Newport Beach, California, United States, 92663
      • Steve Yoelin Medical Associates
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Brian Biesman, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle	Drug: Vehicle; Vehicle ophthalmic gel
Experimental: LEV102 Topical Gel, 2.0%	Drug: LEV102 2.0%; Oxymetazoline ophthalmic gel
Experimental: LEV102 Topical Gel, 1.0%	Drug: LEV102 1.0%; Oxymetazoline ophthalmic gel

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1

Collaborators and Investigators

• Sponsor: Levation Pharma, Ltd.
• Investigators: Study Chair: Houman D Hemmati, MD PhD, Levation Pharma, Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2023
• Primary Completion (Actual): June 24, 2023
• Study Completion (Actual): June 24, 2023

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: January 27, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Blepharoptosis
• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Blepharoptosis
• Other Study ID Numbers: LEV102-CS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No