CataractPhase 1NCT05441930
A Study of Levofloxacin Ocular Implant in Patients Undergoing Routine Bilateral Cataract Surgery
A Phase 1 study testing Levofloxacin Ocular Implant in people with Cataract, run by PolyActiva Pty Ltd at 3 sites in 2 countries.
Trial summary
Open label controlled interventional study in eyes in up to 12 subjects (24 eyes) scheduled for uncomplicated bilateral cataract surgery on separate days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Levofloxacin Ocular Implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 23 Jun 2023to 14 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects 18 years of age or older.
- Willing and able to understand and sign an informed consent form prior to any study-related procedures.
- Willing and able to follow study instructions, and able to be present for the required study visits/assessments for the duration of the study.
- Diagnosis of cataract in both eyes scheduled for sequential bilateral elective cataract extraction by phacoemulsification and posterior chamber IOL implantation not combined with any other surgery except femtosecond laser.
- Minimum endothelial cell density (ECD) in both eyes of greater than or equal to 2000 cells per mm2.
- Fully vaccinated against COVID-19, as evidenced by vaccination record.
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- Key Opthalmic Exclusion Criteria
- Ophthalmic:
- Have a history of or current uveitis, macular edema (cystoid or diabetic), diabetic retinopathy, retinal vein occlusion and neovascular glaucoma, corneal conditions such as keratitis, corneal edema or advanced macular degeneration, which in the opinion of the investigator would interfere with study assessments and confound the data.
- In the opinion of the investigator or reading center, have confluent central corneal guttatae, multiple central guttatae greater than a single cell, or corneal disease or abnormality that would prevent specular microscopy corneal scans.
- Aphakia or low vision or monocular.
- Have had any intraocular surgery, glaucoma surgery (including but not limited to filtering surgery like trabeculectomy, Ahmed valve, etc) or cornea/refractive surgery within the past 6 months or anticipate a need for eye surgery (including laser) during the study period.
- Use of prostaglandin (PG) analogues within 60 days prior to Screening or during the course of the study.
- Subjects with clinically diagnosed Fuchs' Endothelial Corneal Dystrophy (FECD)/ history of keratoplasty.
- Subjects for whom an intra-ocular or glaucoma device procedure is planned during the cataract procedure, during study participation or has been previously undertaken.
- Have a current retinal detachment or history of blunt trauma in either eye.
- Subject who in the opinion of the surgeon has a high risk of the posterior capsule being compromised/zonular dehiscence during cataract surgery.
- Intraoperative complications during the cataract surgery including posterior capsule rupture, zonular dehiscence, non-placement of Posterior Chamber Intra Ocular Lens (PCIOL), vitreous prolapse, lens fragments in the vitreous, placement of Anterior Chamber Intra Ocular Lens (ACIOL), uncontrolled bleeding /hyphema.
- Known sensitivity to any component of the product (e.g. fluoroquinolone or polyurethane sensitivity), or to topical therapy used during course of study (e.g., povidone iodine, or anesthetics).
- Used fluoroquinolone antibiotics (topically, orally or systemically) during the 4 weeks before screening visit.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Carolina Cataract and Laser Centre
Ladson, South Carolina, 29456
Ophthalmology Associates
St Louis, Missouri, 63131
About this study
Official title: An Interventional, Open Label, Controlled, Randomized, Pairwise, Phase Ib Safety, Tolerability and Pharmacokinetic (PK) Study of Levofloxacin Ocular Implant in Patients Undergoing Routine Bilateral Cataract Surgery
Open label controlled interventional study in eyes in up to 12 subjects (24 eyes) scheduled for uncomplicated bilateral cataract surgery on separate days.
Read the detailed description
This is a multicenter, open label, controlled, pairwise, interventional study in eyes in up to 12 subjects (24 eyes) scheduled for uncomplicated bilateral cataract surgery on separate days. Eligible individuals provide informed consent; and are screened for inclusion in the study.
Once eligible, subject eyes will be randomized to determine which eye will receive the first surgery. After the first surgery, study participants will receive the control treatment consisting of commercially available topical medications. For the second cataract surgery, study participants will receive a single Levofloxacin Ocular Implant in the posterior sulcus in the surgical eye at the end of cataract surgery. No sham dosing will be conducted in the eyes in the control arm.
- Conditions
- Cataract
- Being tested
- Levofloxacin Ocular Implant, Control
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levofloxacin Ocular ImplantDrug
Levofloxacin Ocular Implant an implant that delivers a bolus dose of levofloxacin and a constant daily dose for a further 5-7 days.
ControlDrug
Commercially available topical medications as per LEVO-CS102 Surgical Therapy Procedure.
| Study group | Role | What they receive |
|---|---|---|
| Levofloxacin Ocular Implant | Experimental | Biphasic levofloxacin antibiotic implant Receives: Drug: Levofloxacin Ocular Implant |
| Control | Active comparator | Commercially available topical medications as per LEVO-CS102 Surgical Therapy Procedure. Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the Levofloxacin Ocular Implant
Descriptive summary statistics will be used to assess the number and frequency of ocular and non ocular adverse events
Measured: Day 90
Levofloxacin concentration in aqueous humor at Day 5 in treated eyes
To determine levofloxacin concentration in aqueous humor at Day 5 in eyes with the Levofloxacin Ocular Implant to facilitate dose adjustment for Phase II studies.
Measured: Day 5
Secondary outcomes (1)
Number of actuations required to administer the implant
Clinicians administering the implant will record the number of actuations required to use the custom-built administration device
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start23 Jun 2023 (estimated)
- Primary completion15 Dec 2023 (estimated)
- Study completion14 Mar 2024 (estimated)
Why it stopped: Sponsor has suspended study to conserve capital for clinical development of lead asset
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Once eligible, subject eyes will be randomized to determine which eye will receive the first surgery. After the first surgery, study participants will receive the control treatment consisting of commercially available topical medications. For the second cataract surgery, study participants will receive a single Levofloxacin Ocular Implant in the posterior sulcus in the surgical eye at the end of cataract surgery. No sham dosing will be conducted in the eyes in the control arm.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- PolyActiva Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Coote, MD, Principal investigator, Melbourne Eye Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05441930
- Sponsor's protocol ID
- LEVO-CS102
- Status last verified
- Apr 2024
- First submitted
- 19 Jun 2022
- Last updated
- 12 Apr 2024
- Results posted
- No
- 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 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional, Open Label, Controlled, Randomized, Pairwise, Phase Ib Safety, Tolerability and Pharmacokinetic (PK) Study of Levofloxacin Ocular Implant in Patients Undergoing Routine Bilateral Cataract Surgery
- ClinicalTrials.gov ID
- NCT05441930
- Acronym / sponsor ID
- LEVO-CS102
- Conditions
- Cataract
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor has suspended study to conserve capital for clinical development of lead asset
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PolyActiva Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2023 (estimated)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 14 Mar 2024 (estimated)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open label controlled interventional study in eyes in up to 12 subjects (24 eyes) scheduled for uncomplicated bilateral cataract surgery on separate days.
Detailed description
This is a multicenter, open label, controlled, pairwise, interventional study in eyes in up to 12 subjects (24 eyes) scheduled for uncomplicated bilateral cataract surgery on separate days. Eligible individuals provide informed consent; and are screened for inclusion in the study.
Once eligible, subject eyes will be randomized to determine which eye will receive the first surgery. After the first surgery, study participants will receive the control treatment consisting of commercially available topical medications. For the second cataract surgery, study participants will receive a single Levofloxacin Ocular Implant in the posterior sulcus in the surgical eye at the end of cataract surgery. No sham dosing will be conducted in the eyes in the control arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Once eligible, subject eyes will be randomized to determine which eye will receive the first surgery. After the first surgery, study participants will receive the control treatment consisting of commercially available topical medications. For the second cataract surgery, study participants will receive a single Levofloxacin Ocular Implant in the posterior sulcus in the surgical eye at the end of cataract surgery. No sham dosing will be conducted in the eyes in the control arm.
| Arm | Type | Receives |
|---|---|---|
| Levofloxacin Ocular Implant | Experimental | Drug: Levofloxacin Ocular ImplantBiphasic levofloxacin antibiotic implant |
| Control | Active comparator | Drug: ControlCommercially available topical medications as per LEVO-CS102 Surgical Therapy Procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Male or female subjects 18 years of age or older.
- Willing and able to understand and sign an informed consent form prior to any study-related procedures.
- Willing and able to follow study instructions, and able to be present for the required study visits/assessments for the duration of the study.
- Diagnosis of cataract in both eyes scheduled for sequential bilateral elective cataract extraction by phacoemulsification and posterior chamber IOL implantation not combined with any other surgery except femtosecond laser.
- Minimum endothelial cell density (ECD) in both eyes of greater than or equal to 2000 cells per mm2.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Levofloxacin Ocular ImplantLevofloxacin Ocular Implant an implant that delivers a bolus dose of levofloxacin and a constant daily dose for a further 5-7 days. | Drug | Levofloxacin Ocular Implant |
| ControlCommercially available topical medications as per LEVO-CS102 Surgical Therapy Procedure. | Drug | Control |
Primary outcome
Safety of the Levofloxacin Ocular Implant
Time frame: Day 90
Descriptive summary statistics will be used to assess the number and frequency of ocular and non ocular adverse events
Levofloxacin concentration in aqueous humor at Day 5 in treated eyes
Time frame: Day 5
To determine levofloxacin concentration in aqueous humor at Day 5 in eyes with the Levofloxacin Ocular Implant to facilitate dose adjustment for Phase II studies.
1 secondary outcome
Number of actuations required to administer the implant
Time frame: Day 0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- 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.
Michael Coote, MD principal investigator
Melbourne Eye Specialists
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Levofloxacin Ocular Implant in people with Cataract, run by PolyActiva Pty Ltd at 3 sites in 2 countries.
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 20 inclusion and 0 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: withdrawn, as of the sponsor's last update on 12 Apr 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, Australia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Safety of the Levofloxacin Ocular Implant (time frame: Day 90). The study lists 2 primary outcomes in all. 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 12 Apr 2024.