CataractPhase 1NCT04682288
Levofloxacin Ocular Implant for Ocular 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
This is a multi center, open label, interventional study in one eye of 5 subjects scheduled for uncomplicated cataract surgery with administration of a single Levofloxacin Ocular Implant in the posterior sulcus of the surgical eye at the end of cataract surgery. 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
- 5 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 4 Jan 2021to 14 Oct 2021
- 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
- Diagnosis of cataract in the intent to treat eye
- Endothelial cell density in the study eye of at least 2000 cells per mm2
Who cannot join
- history of ocular inflammation including, macular degeneration, uveitis, macular edema or corneal edema
- recent surgery in the study eye
- subjects receiving a glaucoma device in conjunction with cataract surgery
- subjects with a compromised posterior capsule during surgery
- corneal disease that prevents effective imaging of endothelium including Fuch's Dystrophy.
- sensitivity to fluoroquinolones
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 Consultants Ltd
St Louis, Missouri, 63131
About this study
Official title: An Interventional, Open Label, Non-randomized, Phase Ia Safety and Tolerability Study of Levofloxacin Ocular Implant in Subjects Undergoing Routine Cataract Surgery.
This is a multi center, open label, interventional study in one eye of 5 subjects scheduled for uncomplicated cataract surgery with administration of a single Levofloxacin Ocular Implant in the posterior sulcus of the surgical eye at the end of cataract surgery.
- Conditions
- Cataract
- Being tested
- Levofloxacin Ocular Implant
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Levofloxacin Ocular Implant | Experimental | Biphasic levofloxacin antibiotic implant Receives: Drug: Levofloxacin Ocular Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Inflammation
Change assessed according to Standardization of Uveitis Nomenclature (SUN) Grading Scale
Measured: 90 days
Endothelial Cell Density
Change in number of central corneal endothelial cells per mm2
Measured: 90 days
Intraocular Pressure (IOP)
Change in IOP measured by Goldmann applenation tonometry
Measured: 90 days
Secondary outcomes (1)
Administration procedure
Number of actuation's required to expel implant
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start4 Jan 2021
- Primary completion14 Oct 2021
- Study completion14 Oct 2021
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- PolyActiva Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Gira, MD, Principal investigator, Opthalmology Consultants Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682288
- Sponsor's protocol ID
- LEVO-CS101
- Status last verified
- Dec 2021
- First submitted
- 8 Nov 2020
- Last updated
- 8 Dec 2021
- 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 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional, Open Label, Non-randomized, Phase Ia Safety and Tolerability Study of Levofloxacin Ocular Implant in Subjects Undergoing Routine Cataract Surgery.
- ClinicalTrials.gov ID
- NCT04682288
- Acronym / sponsor ID
- LEVO-CS101
- Conditions
- Cataract
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- PolyActiva Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 23 Dec 2020 (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.
This is a multi center, open label, interventional study in one eye of 5 subjects scheduled for uncomplicated cataract surgery with administration of a single Levofloxacin Ocular Implant in the posterior sulcus of the surgical eye at the end of cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levofloxacin Ocular Implant | Experimental | Drug: Levofloxacin Ocular ImplantBiphasic levofloxacin antibiotic implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of cataract in the intent to treat eye
- Endothelial cell density in the study eye of at least 2000 cells per mm2
Key exclusion criteria (6 listed)
- history of ocular inflammation including, macular degeneration, uveitis, macular edema or corneal edema
- recent surgery in the study eye
- subjects receiving a glaucoma device in conjunction with cataract surgery
- subjects with a compromised posterior capsule during surgery
- corneal disease that prevents effective imaging of endothelium including Fuch's Dystrophy.
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 |
Primary outcome
Ocular Inflammation
Time frame: 90 days
Change assessed according to Standardization of Uveitis Nomenclature (SUN) Grading Scale
Endothelial Cell Density
Time frame: 90 days
Change in number of central corneal endothelial cells per mm2
Intraocular Pressure (IOP)
Time frame: 90 days
Change in IOP measured by Goldmann applenation tonometry
1 secondary outcome
Administration procedure
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- 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.
Joseph Gira, MD principal investigator
Opthalmology Consultants Ltd
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 2 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 8 Dec 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ocular Inflammation (time frame: 90 days). The study lists 3 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 8 Dec 2021.