CompletedPhase 1/2

LEV102 Topical Gel in Acquired Blepharoptosis

United States33 participantsStarted 2023-02-23

Plain-language summary

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

Who can participate

Age range25 Years – 99 Years

SexALL

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Inclusion criteria

✓. 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):
✓. 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

What they're measuring

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

Timeframe: Day 2-5

Trial details

NCT IDNCT05715346

SponsorLevation Pharma, Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-24

Results submitted2024-09-04

View on ClinicalTrials.gov More Acquired Blepharoptosis trials