WithdrawnPhase 1

A Study of Levofloxacin Ocular Implant in Patients Undergoing Routine Bilateral Cataract Surgery

Stopped: Sponsor has suspended study to conserve capital for clinical development of lead asset

United States, Australia0Started 2023-06-23

Plain-language summary

Open label controlled interventional study in eyes in up to 12 subjects (24 eyes) scheduled for uncomplicated bilateral cataract surgery on separate days.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety of the Levofloxacin Ocular Implant

Timeframe: Day 90

Levofloxacin concentration in aqueous humor at Day 5 in treated eyes

Timeframe: Day 5

Trial details

NCT IDNCT05441930

SponsorPolyActiva Pty Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-15

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