Multicenter, randomized, double-blind, parallel-group clinical study comparing RD03/2016 (levoFloxacin and ketorolac trometAmol) eye drops vs Leviosa® (levofloxacin and dexamethaSone 21-phosphaTe) eye drops for 7 days for the prevention and treatment of inflammation and prevention of infection associated with cataract surgery in adults. (FAST 7)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-525594-39-00

Enrollment

Registered

2026-07-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Brief summary

The proportion of patients with «absence of signs of anterior chamber inflammation (cells and flare)» after 7 days of treatment (Day 8).

Detailed description

Proportion of patients with conjunctival hyperemia at Day 8., Proportion of patients with ocular pain/discomfort at Day 8., Proportion of patient using rescue therapy during treatment., Proportion of patients with onset endophthalmitis at Day 8.

Interventions

DRUGLeviosa® 1 mg/ml + 5 mg/ml

DRUGcollirio

DRUGsoluzione

DRUGlevofloxacin 5mg/ml and ketorolac trametamol 5mg/ml

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The proportion of patients with «absence of signs of anterior chamber inflammation (cells and flare)» after 7 days of treatment (Day 8).	—

Secondary

Measure	Time frame
Proportion of patients with conjunctival hyperemia at Day 8., Proportion of patients with ocular pain/discomfort at Day 8., Proportion of patient using rescue therapy during treatment., Proportion of patients with onset endophthalmitis at Day 8.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 9, 2026