Acquired BlepharoptosisPhase 1/2NCT05715346
LEV102 Topical Gel in Acquired Blepharoptosis
A Phase 1/2 study testing LEV102 1.0% and LEV102 2.0% in people with Acquired Blepharoptosis, run by Levation Pharma, Ltd. at 3 sites in United States.
Trial summary
Phase 1/2a, multicenter, randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study conducted in adult subjects with acquired blepharoptosis. Read more about this study
- Who is it for?
- Ages 25 to 99 years
- Conditions the study is for
- Acquired Blepharoptosis
- What is being tested?
- LEV102 1.0% and LEV102 2.0%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Feb 2023to 24 Jun 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who meet all the following inclusion criteria will be eligible to participate in the study. Subjects must:
- 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):
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Brian Biesman, M.D
Nashville, Tennessee, 37203
Eye Research Foundation
Newport Beach, California, 92663
Steve Yoelin Medical Associates
Newport Beach, California, 92663
About this study
Official title: A Phase 1/2a Study of LEV102 Topical Gel in Subjects With Acquired Blepharoptosis
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):
- Conditions
- Acquired Blepharoptosis
- Being tested
- LEV102 1.0%, LEV102 2.0%, Vehicle
- Keywords
- Blepharoptosis
- Medical subject headings
- Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEV102 1.0%Drug
Oxymetazoline ophthalmic gel
LEV102 2.0%Drug
Oxymetazoline ophthalmic gel
VehicleDrug
Vehicle ophthalmic gel
| Study group | Role | What they receive |
|---|---|---|
| LEV102 Topical Gel, 2.0% | Experimental | Not described Receives: Drug: LEV102 2.0% |
| LEV102 Topical Gel, 1.0% | Experimental | Not described Receives: Drug: LEV102 1.0% |
| Vehicle | Placebo comparator | Not described Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability])
Adverse events
Measured: 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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start23 Feb 2023
- Primary completion24 Jun 2023
- Study completion24 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acquired BlepharoptosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-masked parallel
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Levation Pharma, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Houman D Hemmati, MD PhD, Study chair, Levation Pharma, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05715346
- Sponsor's protocol ID
- LEV102-CS01
- Status last verified
- Oct 2024
- First submitted
- 27 Jan 2023
- Last updated
- 13 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Study of LEV102 Topical Gel in Subjects With Acquired Blepharoptosis
- ClinicalTrials.gov ID
- NCT05715346
- Acronym / sponsor ID
- LEV102-CS01
- Conditions
- Acquired Blepharoptosis
- Keywords
- Blepharoptosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Levation Pharma, Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 24 Jun 2023 (actual)
- Study completion
- 24 Jun 2023 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Posted 13 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1/2a, multicenter, randomized, vehicle-controlled, double-masked, multiple-dose, parallel-group study conducted in adult subjects with acquired blepharoptosis.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-masked parallel
| Arm | Type | Receives |
|---|---|---|
| LEV102 Topical Gel, 2.0% | Experimental | Drug: LEV102 2.0% |
| LEV102 Topical Gel, 1.0% | Experimental | Drug: LEV102 1.0% |
| Vehicle | Placebo comparator | Drug: Vehicle |
Who may qualify
- Ages
- 25 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects who meet all the following inclusion criteria will be eligible to participate in the study. Subjects must:
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEV102 1.0%Oxymetazoline ophthalmic gel | Drug | LEV102 Topical Gel, 1.0% |
| LEV102 2.0%Oxymetazoline ophthalmic gel | Drug | LEV102 Topical Gel, 2.0% |
| VehicleVehicle ophthalmic gel | Drug | Vehicle |
Primary outcome
Percentage of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability])
Time frame: Day 2-5
Adverse events
1 secondary outcome
Upper Eyelid Height
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Houman D Hemmati, MD PhD study chair
Levation Pharma, Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LEV102 1.0% and LEV102 2.0% in people with Acquired Blepharoptosis, run by Levation Pharma, Ltd. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability]) (time frame: Day 2-5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.