Trials Sponsors Conditions Drugs Pricing

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

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

Leviosa® 1 mg/ml + 5 mg/ml, collirio, soluzioneType not reported

levofloxacin 5mg/ml and ketorolac trametamol 5mg/mlType not reported

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Signed written informed consent must be obtained before any assessment is performed.
Male or female, age ≥40 years.
Scheduled senile or presenile cataract surgery (not yet performed).

Sponsors & Collaborators

Ntc S.r.l.
Industrylead

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Sites (28)

Uniwersytet Medyczny W Lublinie

Lublin, 20-059, Poland

Robert Rejdak815328601 oko@usk1.pl

Linkopings Universitet

Linkoping, 582 25, Sweden

Björn Johansson+460101031254 bjorn.johansson@regionostergotland.se

Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino

Turin, 10126, Italy

Michele Reibaldi+39339653347

Central Study Contacts

Alessandro Colombo

0243850490 alessandro.colombo@ntcpharma.com

Study Design

Study Type: interventional
Phase: phase 3

Study Record Dates

First Submitted

March 31, 2026

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2026-525594-39-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-31 06:50:54 UTC

Documents

D1_LevoKeto_01-2026_Protocol_Redacted

International study on RD03/2016 eye drops compared to Leviosa® eye drops for the prevention and treatment of inflammation and the prevention of infections associated with cataract surgery in adults – FAST 7

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (28)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (28)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations