LEV102 Topical Gel in Acquired Blepharoptosis

Recruiting at 2 trial locations

Overseen By Houman D Hemmati, MD PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Levation Pharma, Ltd.

Must not be taking: Alpha agonists, Decongestants

Disqualifiers: Glaucoma, Ocular infection, Pregnancy, others

Compensation: Varies

Number of Visits: 2

Duration: 1 day

33 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a one-time application of a special medicine on the upper eyelids of adults with drooping eyelids. The goal is to see if the medicine can lift the eyelids. About 30 participants will be involved.

Will I have to stop taking my current medications?

The trial requires that you stop using any systemic, intranasal, topical dermatologic, or ophthalmic α-adrenergic agonists or antagonists, including certain decongestants, within 7 days before the screening and during the study.

Research Team

Houman D Hemmati, MD PhD

Principal Investigator

Levation Pharma, Ltd.

Eligibility Criteria

Inclusion Criteria

Subjects must be male or female subjects 25 years of age or older at the time of Screening (Visit 1)

Subjects must present with the following at Screening (Visit 1):

- 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

Exclusion Criteria

Subjects must not have any active ocular or peri-ocular infection; any history of recurrent or chronic infection or inflammation in either eye

Subjects must not have a history of allergic reaction to the investigational drug or any of its components

Subjects must not have used 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 within 7 days of Screening (Visit 1), or anticipated use during the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a one-time application of randomized, double-masked investigational product on the upper eyelid of both eyes

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 days

1 visit (in-person)

Treatment Details

Interventions

• LEV102

Participant Groups

Group I: LEV102 Topical Gel, 2.0% Experimental Treatment 1 Intervention

Group II: LEV102 Topical Gel, 1.0% Experimental Treatment 1 Intervention

Group III: Vehicle Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Levation Pharma, Ltd.

Lead Sponsor

Trials

1

Recruited

30+