Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery

NCT03739528 | Completed Phase 3 Results

• 1 other identifier: LEVODESA_04-2017
• Study Type: interventional
• Target: 808
• Locations: 1 country
• Sites: 57

Brief Summary

The purpose of this study is to demonstrate the non-inferiority of the study treatment (combined levofloxacin + dexamethasone eye drops) followed by dexamethasone eye drops alone vs. standard treatment in the prevention and treatment of postoperative ocular inflammation and prevention of infection.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Number of Participants Without Signs of Anterior Chamber Inflammation

  The number of participants without signs of anterior chamber inflammation (sum of cells and flare score = 0). The following non-inferiority hypotheses has been tested: H0 : πT - πS ≤ - Δ; H1 : πT - πS \> - Δ. Where πT and πS are the number of participants without signs of anterior chamber inflammation in the test and standard treatments, respectively, and the non-inferiority margin is Δ = 10%.

  Day 15

Secondary Outcomes (6)

• Number of Participants With Endophthalmitis

  Day 4, 8, 15

• Number of Participants Without Signs of Anterior Ocular Chamber Inflammation

  Day 0 (screening), 4, 8

• Conjunctival Hyperemia

  Day 4, 8, 15

• Total Ocular Symptoms Score (TOSS)

  Day 4, 8, 15

• Ocular Pain/Discomfort: 4-point Scale

  Day 4, 8, 15

Other Outcomes (6)

• Intraocular Pressure (IOP)

  At day 0 (screening) and at day 4, 8, 15

• Visual Acuity

  At day 0 (screening) and at day 15

• Adverse Events

  During all the treatment until day 15

Study Arms (2)

Levofloxacin + Dexamethasone followed by dexamethasone

EXPERIMENTAL

Levofloxacin 5 mg/ml+Dexamethasone 1 mg/ml (7 days,1 drop/4 times a day) followed by dexamethasone 1 mg/ml (7 days,1 drop/4 times a day).

Drug: Levofloxacin + dexamethasone followed by dexamethasone

Tobramycin + dexamethasone

ACTIVE COMPARATOR

Tobramycin + dexamethasone (14 days, 1 drop/4 times a day).

Drug: Tobramycin + Dexamethasone

Interventions

Levofloxacin + dexamethasone followed by dexamethasone DRUG

Levofloxacin + dexamethasone ophthalmic solution for 7 days, 1 drop - 4 times a day, followed by dexamethasone ophthalmic suspension (Maxidex®) for an additional 7 days, 1 drop - 4 times a day.

Also known as: Levofloxacin + dexamethasone followed by Maxidex

Levofloxacin + Dexamethasone followed by dexamethasone

Tobramycin + Dexamethasone DRUG

Tobramycin + dexamethasone ophthalmic suspension (Tobradex®) for 14 days, 1 drop - 4 times a day.

Also known as: Tobradex

Tobramycin + dexamethasone

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent
• Male or female, age ≥40 years
• Scheduled senile or presenile cataract surgery
• Willing to interrupt the use of contact lenses for the entire duration of the study
• Able and willing to follow study procedures
• Female patients must be postmenopausal, surgically sterile or must agree to use an effective method of contraception
• Surgery completed without complications

You may not qualify if:

• Ocular conditions that at the discretion of the Investigator may interfere with the efficacy and/or safety evaluations
• Patients undergoing bilateral cataract surgery
• Patients under treatment with prostaglandin analogues or intravitreal injections of anti-vascular endothelial growth factor (VEGF) drugs
• Systemic diseases that may interfere with the results of the study
• Any condition that could interfere with correct instillation of eye drops
• Ocular surgery in the study eye (including laser surgery) in the 3 months before screening
• Monocular patients
• Visual Acuity \< 20/80 of the contralateral eye measured as ETDRS or Snellen
• Contraindications to ocular treatment with Tobradex®, Maxidex® or levofloxacin/dexamethasone
• Hypersensitivity to the study product or its excipients
• Participation in other clinical studies within at least 5 half-lives of the Investigational Medicinal Product (IMP) used in the previous studies
• Pregnancy or breastfeeding

Sponsors & Collaborators

• NTC srl: lead

Study Sites (57)

A.O.U. Osp. Riuniti Umberto I - G.M. Lancisi - G. Salesi - Università degli Studi di Ancona

Ancona, AN, 60126, Italy

Location

Ospedale della Murgia "Fabio Perinei" di Altamura

Altamura, BA, 70022, Italy

Location

A.O.U. Policlinico Consorziale di Bari

Bari, BA, 70125, Italy

Location

ASL Bari - Ospedale "Di Venere" - Carbonara di Bari

Bari, BA, 70131, Italy

Location

Cliniche Gavazzeni S.p.A. - Humanitas Gavazzeni di Bergamo

Bergamo, BG, 24125, Italy

Location

A.O.U. di Bologna - Policlinico S. Orsola-Malpighi di Bologna

Bologna, BO, 40138, Italy

Location

Policlinico S. Orsola-Malpighi di Bologna

Bologna, BO, 40138, Italy

Location

ASST degli Spedali Civili di Brescia - P.O. Spedali Civili di Brescia

Brescia, BS, 25123, Italy

Location

ASST Franciacorta - P.O. di Chiari

Chiari, BS, 25032, Italy

Location

P.O. Ospedale Clinicizzato SS. Annunziata di Chieti

Chieti, CH, 66100, Italy

Location

Ospedale Valduce di Como

Como, CO, 22100, Italy

Location

A.O.U. Policlinico Vittorio Emanuele - P.O. Gaspare Rodolico - Università degli Studi di Catania

Catania, CT, 95123, Italy

Location

Policlinico G.B. Morgagni di Catania - Casa di Cura s.r.l.

Catania, CT, 95125, Italy

Location

A.O. Mater Domini di Catanzaro - Università degli Studi Magna Graecia di Catanzaro

Catanzaro, CZ, 88100, Italy

Location

IRCCS Casa Sollievo della Sofferenza di San Giovanni Rotondo

San Giovanni Rotondo, FG, 71013, Italy

Location

A.O.U. Careggi di Firenze

Florence, FI, 50139, Italy

Location

IRCCS Ospedale Policlinico San Martino di Genova

Genova, GE, 16132, Italy

Location

Ospedale Policlinico San Martino - Università degli Studi di Genova

Genova, GE, 16132, Italy

Location

Fatebenefratelli - Ospedale "Sacra Famiglia" di Erba

Erba, LC, 22036, Italy

Location

Az. USL Toscana Nord Ovest - Ospedale della Versilia

Lido di Camaiore, LU, 55049, Italy

Location

AUSL Toscana Nord Ovest - P.O. San Luca di Lucca

San Filippo, LU, 56123, Italy

Location

A.O.U. Policlinico "G. Martino" di Messina

Messina, ME, 98124, Italy

Location

ASP di Messina - P.O. "Giuseppe Fogliani" di Milazzo

Milazzo, ME, 98057, Italy

Location

ASST Ovest Milanese - Ospedale Civile di Legnano

Legnano, MI, 20025, Italy

Location

IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

Milan, MI, 20122, Italy

Location

Gruppo Multimedica - Ospedale San Giuseppe di Milano

Milan, MI, 20123, Italy

Location

Ospedale San Raffaele IRCCS S.r.l.

Milan, MI, 20132, Italy

Location

ASST Fatebenefratelli Sacco - Università degli Studi di Milano - Ospedale L. Sacco

Milan, MI, 20157, Italy

Location

IRCCS Istituto Clinico Humanitas di Rozzano

Rozzano, MI, 20089, Italy

Location

ASST di Melegnano e della Martesana - Ospedale di Vizzolo Predabissi

Vizzolo Predabissi, MI, 20077, Italy

Location

A.O.U. Policlinico di Modena - Università degli Studi di Modena e Reggio Emilia

Modena, MO, 41125, Italy

Location

Ospedale di Sassuolo

Sassuolo, MO, 41049, Italy

Location

Centro Polispecialistico Monterosso di Carrara

Carrara, MS, 54033, Italy

Location

A.O.U. Policlinico "P. Giaccone" di Palermo

Palermo, PA, 90127, Italy

Location

A.O. "Ospedali Riuniti Villa Sofia-Cervello" di Palermo - P.O. "Villa Sofia" di Palermo

Palermo, PA, 90146, Italy

Location

AUSL di Piacenza - Ospedale "Guglielmo da Saliceto" di Piacenza

Piacenza, PC, Piacenza, Italy

Location

Az. ULSS 6 Euganea - Ospedali Riuniti Padova Sud - Ospedale Madre Teresa di Calcutta-Schiavonia

Monselice, PD), 35043, Italy

Location

Az. ULSS 6 Euganea - Ospedale S. Antonio - Centro Oculistico San Paolo di Padova

Padua, PD, 35100, Italy

Location

A.O. di Perugia - Ospedale S. Maria della Misericordia di Perugia

Perugia, PG, 06156, Italy

Location

Fondazione IRCCS Policlinico S. Matteo - Università degli Studi di Pavia

Pavia, PV, 27100, Italy

Location

Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli di Reggio Calabria

Reggio Calabria, RC, 89124, Italy

Location

Policlinico Universitario Campus Bio-medico di Roma

Roma, RM, 00128, Italy

Location

Fondazione PTV Policlinico Tor Vergata

Roma, RM, 00133, Italy

Location

A.O.U. Sant'Andrea di Roma

Roma, RM, 00189, Italy

Location

IRCCS Fondazione G.B. Bietti di Roma

Roma, RM, 00198, Italy

Location

ASL Roma 4 - Ospedale San Paolo di Civitavecchia

Civitavecchia, RN, 00053, Italy

Location

Az. ULSS 5 Polesana - Ospedale "Santa Maria della Misericordia"

Rovigo, RO, 45100, Italy

Location

A.O.U Città della Salute e della Scienza di Torino - Ospedale Molinette

Torino, TO, 10126, Italy

Location

Az. Sanitaria Universitaria Integrata di Trieste - Ospedali Riuniti di Trieste - Ospedale Maggiore

Trieste, TS, 34129, Italy

Location

Az. ULSS 2 Marca Trevigiana - Ospedale di Treviso

Treviso, TV, 31100, Italy

Location

Az. Sanitaria Universitaria Integrata di Udine - P.O. Universitario "Santa Maria della Misericordia" diUdine

Udine, UD, 33100, Italy

Location

Az. ULSS 7 Pedemontana - Ospedale San Bassiano di Bassano del Grappa

Bassano del Grappa, VI, 36061, Italy

Location

Ospedale Sacro Cuore - Don Calabria di Negrar

Negrar, VR, 37024, Italy

Location

A.O.U. Integrata di Verona - Ospedale Borgo Roma

Verona, VR, 37134, Italy

Location

Az. Osp. di Rilievo Nazionale "A. Cardarelli" di Napoli

Napoli, 80131, Italy

Location

A.O.U. "Maggiore della Carità" di Novara

Novara, 28100, Italy

Location

A.O.U. Senese - Università degli Studi di Siena

Siena, 53100, Italy

Location

MeSH Terms

Conditions

Cataract

Interventions

Levofloxacin; Tobramycin, Dexamethasone Drug Combination

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dexamethasone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Tobramycin; Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Alessandro Colombo
• Organization: NTC srl

alessandro.colombo@ntcpharma.com

+390243850490

Study Officials

• Francesco Bandello, Prof.

  Ospedale San Raffaele IRCCS S.r.l.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, parallel-group study

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: November 14, 2018
• Study Start: September 3, 2018
• Primary Completion: December 19, 2018
• Study Completion: December 19, 2018
• Last Updated: August 18, 2020
• Results First Posted: August 18, 2020

Record last verified: 2020-08

Locations

IT (57)