LEV102 Topical Gel in Acquired Blepharoptosis

Last updated: October 22, 2024
Sponsor: Levation Pharma, Ltd.
Overall Status: Completed

Phase

1/2

Condition

N/A

Treatment

LEV102 1.0%

LEV102 2.0%

Vehicle

Clinical Study ID

NCT05715346
LEV102-CS01
  • Ages 25-99
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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. Have complaints of aesthetically unacceptable upper eyelid position for both eyesmaking them desirous for elevation, or have complaints of superior visual fielddefects in both eyes that impact activities of daily living

  2. Present with the following at Screening (Visit 1): a. At least one eye that meets both of the following criteria: i. Margin ReflexDistance 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, inthe 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 changefrom baseline in MRD1 in both eyes in response to a single drop of oxymetazoline 0.1% ophthalmic solution)to each eye at Screening

  3. Women of Childbearing Potential must agree to use an approved method of birthcontrol from the date they sign the informed consent form (ICF) until after the laststudy visit (Follow-Up Visit)

  4. Be able to give informed consent and willing to comply with all study visits andexaminations

Exclusion

Exclusion Criteria:

  1. Have any other ocular pathology other than ptosis requiring treatment with topicalprescription ophthalmic drops in either eye (e.g., glaucoma, dry eye)

  2. Have narrow angles, glaucoma, intraocular pressure >23 mmHg or diagnosis of ocularhypertension, cup-to-disc ratio of >0.7, or history of any glaucoma eye surgery ineither eye

  3. Have any active ocular or peri-ocular infection; any history of recurrent or chronicinfection or inflammation in either eye

  4. Have a history of allergic reaction to the investigational drug or any of itscomponents

  5. Within 7 days of Screening (Visit 1), or anticipated use during the study, use ofany systemic, intranasal, topical dermatologic, or ophthalmic α-adrenergic agonist (including brimonidine) or antagonist including nasal or ocular or oraldecongestants including pseudoephedrine, oxymetazoline topical ophthalmic solution,oxymetazoline topical dermatologic cream

  6. Subjects who are pregnant or breast-feeding

Study Design

Total Participants: 33
Treatment Group(s): 3
Primary Treatment: LEV102 1.0%
Phase: 1/2
Study Start date:
February 23, 2023
Estimated Completion Date:
June 24, 2023

Study 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):

Connect with a study center

  • Eye Research Foundation

    Newport Beach, California 92663
    United States

    Site Not Available

  • Steve Yoelin Medical Associates

    Newport Beach, California 92663
    United States

    Site Not Available

  • Brian Biesman, M.D

    Nashville, Tennessee 37203
    United States

    Site Not Available

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