We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

LEV102 Topical Gel in Acquired Blepharoptosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05715346
Recruitment Status : Recruiting
First Posted : February 8, 2023
Last Update Posted : March 7, 2023
Sponsor:
Information provided by (Responsible Party):
Levation Pharma, Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Phase 1/2a, multicenter, randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study conducted in adult subjects with acquired blepharoptosis.

Condition or disease Intervention/treatment Phase
Acquired Blepharoptosis Drug: LEV102 1.0% Drug: LEV102 2.0% Drug: Vehicle Phase 1 Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-masked parallel
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double masked
Primary Purpose: Treatment
Official Title: A Phase 1/2a Study of LEV102 Topical Gel in Subjects With Acquired Blepharoptosis
Actual Study Start Date : February 28, 2023
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
Placebo Comparator: Vehicle Drug: Vehicle
Vehicle ophthalmic gel


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) [ Time Frame: Day 2-5 ]
    Adverse events


Secondary Outcome Measures :
  1. Upper eyelid height [ Time Frame: Day 1 ]
    Margin reflex distance 1


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05715346


Contacts
Layout table for location contacts
Contact: Houman D Hemmati, MD PhD (424) 274-2642 info@levationpharma.com

Locations
Layout table for location information
United States, California
Eye Research Foundation Recruiting
Newport Beach, California, United States, 92663
Contact: Linda Wirta    949-650-1863    linda.wirta@drwirta.com   
Steve Yoelin Medical Associates Recruiting
Newport Beach, California, United States, 92663
Contact: Courtney Tp,, MD PhD    949-548-2711    info@levationpharma.com   
United States, Tennessee
Brian Biesman, M.D Recruiting
Nashville, Tennessee, United States, 37203
Contact: Amanda Smith    615-329-1110    info@levationpharma.com   
Sponsors and Collaborators
Levation Pharma, Ltd.
Investigators
Layout table for investigator information
Study Chair: Houman D Hemmati, MD PhD Levation Pharma, Ltd.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Levation Pharma, Ltd.
ClinicalTrials.gov Identifier: NCT05715346    
Other Study ID Numbers: LEV102-CS01
First Posted: February 8, 2023    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Levation Pharma, Ltd.:
Blepharoptosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Blepharoptosis
Eyelid Diseases
Eye Diseases