CClinicalTrials.gg
CompletedNCT05715346Updated Nov 13, 2024Results posted

LEV102 Topical Gel in Acquired Blepharoptosis

A Phase 1/2 interventional study of LEV102 1.0% and LEV102 2.0% in Acquired Blepharoptosis, sponsored by Levation Pharma, Ltd.. Completed at 3 sites in United States. Open to participants aged 25 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-11-13.

Sponsored by Levation Pharma, Ltd. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
33
Allocation
Randomized
Ages
25 Years to 99 Years
Sex
All
01

Study summary

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

Read the 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):

02

Conditions studied

  • Acquired Blepharoptosis

Browse trials for

Keywords

  • Blepharoptosis
03

In context

Blepharoptosis

58 studies on the registry are indexed under Blepharoptosis; 16 are open to participants now.

This study's enrollment of 33 is below the median of 46 across 47 interventional studies indexed under Blepharoptosis.

Browse Blepharoptosis studies →

Lead sponsor

This is the only study on the registry with Levation Pharma, Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
33 participants (actual)

Study arms

  • Experimental
    LEV102 Topical Gel, 2.0%

    Drug: LEV102 2.0%

  • Experimental
    LEV102 Topical Gel, 1.0%

    Drug: LEV102 1.0%

  • Placebo comparator
    Vehicle

    Drug: Vehicle

Interventions

  • DrugLEV102 1.0%

    Oxymetazoline ophthalmic gel

  • DrugLEV102 2.0%

    Oxymetazoline ophthalmic gel

  • DrugVehicle

    Vehicle ophthalmic gel

06

What researchers measure

Primary outcomes

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

    Adverse events

    Time frame: Day 2-5

Secondary outcomes

  1. Upper Eyelid Height

    Percentage of subjects with increase in Margin reflex distance 1 (MRD1) of 1 mm at Hours 2 and 6 on Day 1

    Time frame: Day 1

07

Results

Posted Nov 13, 2024

Participant flow

Participant flow — Overall Study
MilestoneLEV102 Topical Gel, 2.0%LEV102 Topical Gel, 1.0%Vehicle
Started111111
Completed111111
Not completed000

Outcome measures

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

Adverse events

Time frame:
Day 2-5
Reported as:
Count of participants · Participants
Percentage of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability])
ParticipantsLEV102 Topical Gel, 2.0%LEV102 Topical Gel, 1.0%Vehicle
Percentage of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability])000
SecondaryUpper Eyelid Height

Percentage of subjects with increase in Margin reflex distance 1 (MRD1) of 1 mm at Hours 2 and 6 on Day 1

Time frame:
Day 1
Reported as:
Count of participants · Participants
Upper Eyelid Height
ParticipantsLEV102 Topical Gel, 2.0%LEV102 Topical Gel, 1.0%Vehicle
Upper Eyelid Height742

Adverse events

Collected over 2-5 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LEV102 Topical Gel, 2.0%0/11 (0%)0/11 (0%)0/11 (0%)
LEV102 Topical Gel, 1.0%0/11 (0%)0/11 (0%)0/11 (0%)
Vehicle0/11 (0%)0/11 (0%)0/11 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)LEV102 Topical Gel, 2.0%LEV102 Topical Gel, 1.0%VehicleTotal
<=18 years0000
Between 18 and 65 years74415
>=65 years47718
Age, Continuous
Age, Continuous(Years)LEV102 Topical Gel, 2.0%LEV102 Topical Gel, 1.0%VehicleTotal
Mean62.7 ± 10.366.3 ± 15.965.1 ± 11.264.7 ± 11.2
Sex: Female, Male
Sex: Female, Male(Participants)LEV102 Topical Gel, 2.0%LEV102 Topical Gel, 1.0%VehicleTotal
Female98825
Male2338
Race (NIH/OMB)
Race (NIH/OMB)(Participants)LEV102 Topical Gel, 2.0%LEV102 Topical Gel, 1.0%VehicleTotal
American Indian or Alaska Native0000
Asian0011
Native Hawaiian or Other Pacific Islander0000
Black or African American0000
White11111032
More than one race0000
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)LEV102 Topical Gel, 2.0%LEV102 Topical Gel, 1.0%VehicleTotal
United States11111133
08

Study locations

3 sites
  • Eye Research Foundation
    Newport Beach, California 92663, United States
  • Steve Yoelin Medical Associates
    Newport Beach, California 92663, United States
  • Brian Biesman, M.D
    Nashville, Tennessee 37203, United States
09

References and documents

Study documents

  • Study protocol · May 23, 2023
  • Statistical analysis plan · Jun 6, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05715346
Lead sponsor
Levation Pharma, Ltd.
Responsible party
Sponsor
First posted
Feb 8, 2023
Start date
Feb 23, 2023
Primary completion
Jun 24, 2023
Completion
Jun 24, 2023
Results posted
Nov 13, 2024
Last update
Nov 13, 2024

Study contacts

Houman D Hemmati, MD PhD
study chair · Levation Pharma, Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion