search
Back to results

LEV102 Topical Gel in Acquired Blepharoptosis

Primary Purpose

Acquired Blepharoptosis

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LEV102 1.0%
LEV102 2.0%
Vehicle
Sponsored by
Levation Pharma, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Blepharoptosis focused on measuring Blepharoptosis

Eligibility Criteria

25 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eye Research FoundationRecruiting
  • Steve Yoelin Medical AssociatesRecruiting
  • Brian Biesman, M.DRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

LEV102 Topical Gel, 2.0%

LEV102 Topical Gel, 1.0%

Vehicle

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Adverse events

Secondary Outcome Measures

Upper eyelid height
Margin reflex distance 1

Full Information

First Posted
January 27, 2023
Last Updated
March 5, 2023
Sponsor
Levation Pharma, Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05715346
Brief Title
LEV102 Topical Gel in Acquired Blepharoptosis
Official Title
A Phase 1/2a Study of LEV102 Topical Gel in Subjects With Acquired Blepharoptosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Levation Pharma, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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):

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Blepharoptosis
Keywords
Blepharoptosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Double-masked parallel
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double masked
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LEV102 Topical Gel, 2.0%
Arm Type
Experimental
Arm Title
LEV102 Topical Gel, 1.0%
Arm Type
Experimental
Arm Title
Vehicle
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
LEV102 1.0%
Intervention Description
Oxymetazoline ophthalmic gel
Intervention Type
Drug
Intervention Name(s)
LEV102 2.0%
Intervention Description
Oxymetazoline ophthalmic gel
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Vehicle ophthalmic gel
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Description
Adverse events
Time Frame
Day 2-5
Secondary Outcome Measure Information:
Title
Upper eyelid height
Description
Margin reflex distance 1
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Houman D Hemmati, MD PhD
Phone
(424) 274-2642
Email
info@levationpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Houman D Hemmati, MD PhD
Organizational Affiliation
Levation Pharma, Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Wirta
Phone
949-650-1863
Email
linda.wirta@drwirta.com
Facility Name
Steve Yoelin Medical Associates
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Tp,, MD PhD
Phone
949-548-2711
Email
info@levationpharma.com
Facility Name
Brian Biesman, M.D
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Smith
Phone
615-329-1110
Email
info@levationpharma.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

LEV102 Topical Gel in Acquired Blepharoptosis

We'll reach out to this number within 24 hrs