LEV102 Topical Gel in Acquired Blepharoptosis

NCT05715346 | Completed Phase 1 Results FDA Drug

• 1 other identifier: LEV102-CS01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Acquired Blepharoptosis

Keywords

Blepharoptosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability])

  Adverse events

  Day 2-5

Secondary Outcomes (1)

• Upper Eyelid Height

  Day 1

Study Arms (3)

LEV102 Topical Gel, 2.0%

EXPERIMENTAL

Drug: LEV102 2.0%

LEV102 Topical Gel, 1.0%

EXPERIMENTAL

Drug: LEV102 1.0%

Vehicle

PLACEBO COMPARATOR

Drug: Vehicle

Interventions

LEV102 1.0% DRUG

Oxymetazoline ophthalmic gel

LEV102 Topical Gel, 1.0%

LEV102 2.0% DRUG

Oxymetazoline ophthalmic gel

LEV102 Topical Gel, 2.0%

Vehicle DRUG

Vehicle ophthalmic gel

Vehicle

Eligibility Criteria

• Age: 25 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Levation Pharma, Ltd.: lead

Study Sites (3)

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Steve Yoelin Medical Associates

Newport Beach, California, 92663, United States

Location

Brian Biesman, M.D

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Blepharoptosis

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Results Point of Contact

• Title: Houman Hemmati, M.D., Ph.D.
• Organization: Levation Pharma

info@levationpharma.com

424 274 2642

Study Officials

• Houman D Hemmati, MD PhD

  Levation Pharma, Ltd.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-masked parallel

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 8, 2023
• Study Start: February 23, 2023
• Primary Completion: June 24, 2023
• Study Completion: June 24, 2023
• Last Updated: November 13, 2024
• Results First Posted: November 13, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)