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Study of levofloxacin, ketorolac trometamol, and dexamethasone eye drops for preventing inflammation and infection after cataract surgery in adults

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at adults undergoing surgery to remove a clouded lens, known as Cataract. After the operation, swelling (called inflammation) and germs (called infection) can cause problems. The trial compares two types of eye drops: one that contains levofloxacin together with dexamethasone, and another that contains the same antibiotic together with ketorolac trometamol and is identified by the code RD03/2016. The purpose of the study is to determine whether the new combination is not worse than the existing one in preventing post‑surgical swelling.

The trial is set up so that participants are randomly placed into one of the two groups, and neither the doctors nor the participants know which drops they receive (double‑blind). Both groups use the drops four times a day for a week after surgery. The study follows each person for about a week, ending with an examination on the eighth day.

During the final visit, doctors look for signs that the front part of the eye (the anterior chamber) has no swelling or fluid build‑up, that the white of the eye is not unusually red, and that there is no pain or need for extra medication. If any of these problems appear, they are recorded. The study therefore tracks how well the drops keep the eye calm and free of infection after cataract surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    First dose after enrollment

    After signing consent, receive the study eye drops assigned by the randomization. the assigned product is either leviosa® (contains dexamethasone and levofloxacin) or rd03/2016 (contains levofloxacin and ketorolac trometamol).

    The eye drops are provided in a sterile bottle for ophthalmic use, meaning they are applied to the eye.

    The prescribed amount is 4 gtt (drops) per administration, to be given for a total of 7 days.

  2. Step 2

    Daily administration of eye drops

    Each day, apply 4 drops of the assigned eye drops into the operated eye(s) as instructed by the study team.

    The treatment continues for seven consecutive days. the total treatment period is therefore 7 days.

  3. Step 3

    Monitoring and recording symptoms

    Throughout the 7‑day treatment, note any eye discomfort, pain, redness, or other changes and report them to the study staff during scheduled visits or phone calls.

    If severe pain or infection occurs, the study protocol allows the use of rescue therapy, which will be recorded.

  4. Step 4

    Final assessment on day 8

    On day 8 (the day after the last dose), attend a study visit for an eye examination.

    The examiner will check for absence of inflammation signs, redness (conjunctival hyperemia), pain, and any signs of infection such as endophthalmitis.

    The results are used to evaluate the effectiveness of the assigned eye drops.

  5. Step 5

    Completion of study participation

    After the day‑8 assessment, the study participation ends. no further study medication is required.

    Any remaining study eye drops are returned according to study instructions.

Who can join the trial?

7 criteria

  • Signed written informed consent must be given before any study steps, meaning you read and sign a form that explains the trial and you agree to take part.
  • You must be a man or woman who is at least 40 years old.
  • You need to be scheduled for cataract surgery for age‑related (senile) or early‑onset (presenile) cataracts, and the surgery must not have been done yet.
  • You must agree to stop wearing contact lenses for the entire time you are in the study.
  • You must be able and willing to follow all the study instructions and visits.
  • If you are a woman who could become pregnant (childbearing potential), you must use a very reliable birth‑control method (highly effective contraception) and agree to keep using it during the study.
  • Your cataract surgery must be completed without any problems or complications.

Who cannot join the trial?

12 criteria

  • Eye conditions that might affect the study results, such as ocular herpes (a viral eye infection), blepharitis (inflammation of the eyelid margin), conjunctivitis (pink eye), uveitis (inflammation inside the eye), keratitis (cornea inflammation), diabetic retinopathy (damage to the retina caused by diabetes), retinal vein occlusions, retinal vasculitis, retinal angiomatous proliferation, pseudo‑exfoliation syndrome (a condition where flaky material builds up on eye structures), and intraoperative floppy iris syndrome (iris that moves excessively during surgery).
  • Allergy (hypersensitivity) to the study medicines or any of their inactive ingredients.
  • Having taken part in another clinical study where the previous drug has not cleared at least five half‑lives (the time needed for half of the drug to leave the body).
  • Being pregnant or breastfeeding.
  • Having cataract surgery on both eyes at the same time (bilateral surgery).
  • Using eye medicines such as prostaglandin analogues (drops that lower eye pressure) or receiving intravitreal injections of anti‑VEGF drugs (injections that block abnormal blood vessel growth in the eye).
  • Having systemic (whole‑body) diseases that could affect the study, such as rheumatoid arthritis, Sjögren's syndrome, Behçet's disease, systemic lupus erythematosus, or scleroderma with major eye involvement.
  • Any condition that would make it difficult to correctly instill (put) eye drops.
  • Having had any eye surgery (including laser surgery) on the study eye within the past three months.
  • Having only one functional eye (monocular).
  • Having vision worse than 20/80 (or 0.25 in decimal) in the other eye, measured with standard eye charts.
  • Having a contraindication (a reason not to use) to the study eye medicines (ketorolac, dexamethasone, or levofloxacin), such as herpes simplex keratitis (viral infection of the cornea), vaccinia, varicella, other viral eye diseases, fungal or mycobacterial eye infections, untreated parasitic eye infections, uncontrolled high eye pressure (intraocular hypertension) or glaucoma, untreated pus‑filled (purulent) eye infections, or acute untreated bacterial eye infections.
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Investigated drugs

  • Leviosa® eye drops

    are a combination eye‑drop solution that contains a steroid medication and an antibiotic. The steroid (dexamethasone) helps to reduce swelling, redness, and pain after eye surgery, while the antibiotic (levofloxacin) works to stop bacteria from causing an infection. In this study the drops were given to patients after cataract surgery to see how well they prevent and treat inflammation and keep the eye free from infection.

  • Levofloxacin and ketorolac eye drops

    are a combination eye‑drop solution that also contains an antibiotic and a non‑steroidal anti‑inflammatory drug. The antibiotic (levofloxacin) protects the eye from bacterial infection, and the anti‑inflammatory (ketorolac) reduces swelling, redness, and discomfort after surgery. In the trial this product was tested as an alternative to Leviosa® for preventing and treating inflammation and infection following cataract surgery.

What is already known about the treatment

  • Leviosa® 1 mg/ml + 5 mg/ml, collirio, soluzione

    This eye‑drop solution is applied to the eye, typically four drops daily for seven days after cataract surgery. It combines dexamethasone, a corticosteroid that works by binding glucocorticoid receptors and lowering inflammatory chemicals, with levofloxacin, a fluoroquinolone antibiotic that blocks bacterial DNA‑gyrase and topoisomerase IV. Both ingredients are approved and widely used in ophthalmology, making the product an established treatment for preventing post‑operative inflammation and infection. Pharmacologically it is classified as a corticosteroid anti‑inflammatory and a fluoroquinolone antibacterial.

  • levofloxacin 5 mg/ml and ketorolac trometamol 5 mg/ml

    This ophthalmic solution is also given as four drops daily for seven days following cataract surgery. It contains levofloxacin, which kills bacteria by inhibiting DNA‑gyrase and topoisomerase IV, and ketorolac trometamol, a non‑steroidal anti‑inflammatory drug that blocks cyclo‑oxygenase enzymes to reduce prostaglandin‑mediated inflammation and pain. Both drugs are approved for eye use, and the combination is being tested as a newer option to prevent infection and control inflammation after surgery. The product belongs to the fluoroquinolone antibiotic class and the NSAID class.

Investigated diseases

Cataract - A cataract is a clouding of the eye’s natural lens that gradually reduces its transparency. As the lens becomes hazier, vision may become blurry and colors appear faded. Light may scatter inside the eye, causing glare or halos around lights. The condition typically develops slowly over months or years and can affect one or both eyes. Everyday tasks such as reading or driving may become more difficult as the cataract progresses.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525594-39-00Protocol codeLevoketo_01-2026Estimated enrolment536 patientsSponsorNtc S.r.l.

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