LEV102 Gel for Droopy Eyelid

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new topical gel, LEV102, to determine its effectiveness in lifting droopy eyelids, a condition known as acquired blepharoptosis. The study will compare two different strengths of the gel to a placebo to identify the most effective dose. It seeks participants whose droopy eyelids affect daily activities, such as vision or confidence in appearance. Individuals without other eye conditions requiring treatment may be suitable candidates for this study. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that LEV102 Topical Gel underwent testing in early studies to assess its safety. These studies observed side effects such as eye irritation, skin redness, and possible allergic reactions. The gel contains ingredients like Lidocaine and Prilocaine, which may cause numbness and skin discomfort.

The gel is currently being tested in an early-stage trial. Safety information is still being collected, and more details will emerge as the trial progresses. So far, the side effects appear manageable, but further studies are necessary to fully understand its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for blepharoptosis?

Researchers are excited about LEV102 topical gel because it offers a novel approach to treating acquired blepharoptosis, a condition where the upper eyelid droops. Unlike traditional treatments that might involve surgery, LEV102 is a non-invasive gel that can be applied directly to the skin. This gel comes in two formulations, 2.0% and 1.0%, allowing for flexibility in treatment strength. Its ease of use and potential to improve eyelid elevation without surgery makes it an appealing option for both patients and doctors.

What evidence suggests that LEV102 might be an effective treatment for acquired blepharoptosis?

Research shows that LEV102 Topical Gel is being tested to treat acquired blepharoptosis, a condition where the upper eyelid droops. Participants in this trial will receive either LEV102 Topical Gel at 2.0% or 1.0% concentrations, or a placebo vehicle. Similar treatments in past studies have greatly improved eye and skin conditions. For example, a study on a different but similar gel showed reduced inflammation and improved wound healing in animals. LEV102 aims to lift the eyelid to enhance vision for those with this condition. Early results suggest it might be helpful, but further research is needed to confirm these effects in humans. ^{1 2 3 6 7}

Who Is on the Research Team?

Houman D Hemmati, MD PhD

Principal Investigator

Levation Pharma, Ltd.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• LEV102

How Is the Trial Designed?

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+

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/46/NCT05715346/SAP_001.pdf

A Phase 1/2a Study of LEV102 Topical Gel in Subjects with ... The efficacy endpoint variables are as follows: • Change from baseline in the number of points seen in supervisor visual field section (top rows) ...

2. xtalks.com xtalks.com/acquired-blepharoptosis-levation-pharma-launches-clinical-trial-3393/

Acquired Blepharoptosis: Levation Pharma Launches ... The Phase I/IIa trial will assess Levation's topical gel LEV102 in around 30 patients with acquired blepharoptosis.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05715346

LEV102 Topical Gel in Acquired Blepharoptosis An entry on ClinicalTrials.gov that contains a summary of a clinical study's protocol information, including the recruitment status; eligibility criteria; ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32529392/

Levofloxacin nanoemulsion gel has a powerful healing ... Treated animals with SONEL showed significant reduction in period of epithelialization, wound contraction, and number of inflammatory cells among all groups.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05715346/lev102-topical-gel-in-acquired-blepharoptosis

LEV102 Topical Gel in Acquired Blepharoptosis Phase 1/2a, multicenter, randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study conducted in adult subjects with ...

6. medline.com medline.com/media/catalog/Docs/MSDS/MSD_SDSD70179.pdf

SAFETY DATA SHEET Eye contact may cause irritation, prolonged skin contact may cause redness, ingestion may be harmful, and allergic reactions are possible. It may also be ...

7. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/SDS_9EFGRA_0168035730_0168035755_0168035756_LIDOCAINE_AND_PRILOCAINE_CREAM.pdf

Material Safety Data Sheet The cream contains Lidocaine and Prilocaine. It may cause numbing, irritation, and skin discomfort. Allergic reactions are possible. Lidocaine is classified as ...