Randomized trial of RD03/2016 (levofloxacin/ketorolac) versus dexamethasone/levofloxacin eye drops for inflammation/infection after cataract surgery

The primary objective is to demonstrate the non‑inferior postoperative ocular inflammation efficacy of the investigational levofloxacin/ketorolac eye drops compared with Leviosa® over a 7‑day treatment period following cataract surgery, thereby establishing an alternative therapeutic option for controlling inflammation after the procedure.

Secondary objectives include:

• Description of conjunctival hyperemia on Day 8.
• Description of ocular pain or discomfort on Day 8.
• Assessment of rescue therapy utilization during the treatment course.
• Determination of the incidence of endophthalmitis.

The trial enrolled adult patients aged 40 years and older of both sexes, identified as candidates for senile or presenile cataract surgery. Participants were required to have scheduled surgery that was subsequently completed without intra‑operative complications and to be able to discontinue contact‑lens wear for the study duration. Selection was based on signed informed consent and fulfillment of principal inclusion criteria, including ability to adhere to study procedures and, for women of child‑bearing potential, use of highly effective contraception. Both male and female subjects, including individuals classified as vulnerable, were eligible, provided they met the health status defined by uncomplicated cataract extraction. Lifestyle considerations were limited to the temporary interruption of contact‑lens use; no specific dietary or physical‑activity restrictions were imposed. The sponsor did not provide information on the total number of participants.

The study is a multicenter, randomized, double-blind, parallel-group Phase III trial comparing levofloxacin + ketorolac eye drops (test) with Leviosa® (levofloxacin + dexamethasone) eye drops (comparator) administered four drops daily for 7 days following uncomplicated cataract surgery in adults aged ≥40 years. After obtaining signed informed consent, participants attend a screening visit to confirm eligibility, followed by a baseline visit on the day of surgery during which the first dose is administered. Subsequent study visits occur on Day 4 (mid‑treatment safety check) and Day 8 (end‑of‑treatment assessment), where the primary endpoint—the proportion of patients with anterior chamber inflammation absent—is evaluated, together with secondary outcomes such as conjunctival hyperemia, ocular pain, rescue therapy use, and endophthalmitis incidence. The total participant involvement spans approximately 8 days from screening to the end‑of‑study visit. Early termination may occur if postoperative complications arise, if the participant withdraws consent, or if protocol‑required assessments cannot be completed.

The investigational product, designated RD03/2016, consists of a ophthalmic solution containing levofloxacin hemihydrate 5 mg/ml combined with ketorolac trometamol 5 mg/ml. The medication is supplied as sterile eye drops for topical ocular use. Each administered dose comprises four drops (4 Gtt) delivered to the study eye(s) via the conjunctival sac. The dosing regimen is applied once daily for a total treatment period of seven days following cataract surgery.

The active comparator, Leviosa® eye drops, is a combination ophthalmic solution containing dexamethasone 1 mg/ml and levofloxacin 5 mg/ml. The product is provided in a sterile eye‑drop formulation for topical administration. Participants receive four drops (4 Gtt) per dose, administered once daily for seven consecutive days after the surgical procedure.

Both study medications are administered by the same route (ophthalmic) and dosage volume, with compliance monitored through patient dosing diaries and the return of used dropper bottles at each study visit. The study protocol specifies that dosing must occur at the same time each day to ensure consistent drug exposure throughout the treatment period.

Efficacy will be assessed by determining the proportion of patients with absence of signs of anterior chamber inflammation (cells and flare) after 7 days of treatment (Day 8). Secondary efficacy assessments include the proportion of patients with conjunctival hyperemia, ocular pain/discomfort, the need for rescue therapy, and the occurrence of endophthalmitis at Day 8.

All efficacy parameters are measured as categorical outcomes at the specified time point and will be analyzed by comparing the proportion of patients meeting each criterion between the investigational and comparator groups.