Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery
NCT ID: NCT03739528
Last Updated: 2020-08-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
808 participants
INTERVENTIONAL
2018-09-03
2018-12-19
Brief Summary
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Detailed Description
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The combination of tobramycin and dexamethasone is among the most widely used combinations, however, treatment duration and the need for tapering posology over several weeks may favour the development of bacterial resistance. The study treatment associating a broad-spectrum antibiotic with a highly effective corticosteroid that can be used for a short period of time (one week) is therefore of considerable interest.
The aim of this study is to evaluate the non-inferiority of the study treatment, used for a limited period of time and followed by dexamethasone alone, compared to standard treatment in preventing and treating ocular inflammation and in preventing post-operative infection while limiting the emergence of antibiotic resistance.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Levofloxacin + Dexamethasone followed by dexamethasone
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).
Levofloxacin + dexamethasone followed by dexamethasone
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.
Tobramycin + dexamethasone
Tobramycin + dexamethasone (14 days, 1 drop/4 times a day).
Tobramycin + Dexamethasone
Tobramycin + dexamethasone ophthalmic suspension (Tobradex®) for 14 days, 1 drop - 4 times a day.
Interventions
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Levofloxacin + dexamethasone followed by dexamethasone
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.
Tobramycin + Dexamethasone
Tobramycin + dexamethasone ophthalmic suspension (Tobradex®) for 14 days, 1 drop - 4 times a day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female, age ≥40 years
3. Scheduled senile or presenile cataract surgery
4. Willing to interrupt the use of contact lenses for the entire duration of the study
5. Able and willing to follow study procedures
6. Female patients must be postmenopausal, surgically sterile or must agree to use an effective method of contraception
7. Surgery completed without complications
Exclusion Criteria
2. Patients undergoing bilateral cataract surgery
3. Patients under treatment with prostaglandin analogues or intravitreal injections of anti-vascular endothelial growth factor (VEGF) drugs
4. Systemic diseases that may interfere with the results of the study
5. Any condition that could interfere with correct instillation of eye drops
6. Ocular surgery in the study eye (including laser surgery) in the 3 months before screening
7. Monocular patients
8. Visual Acuity \< 20/80 of the contralateral eye measured as ETDRS or Snellen
9. Contraindications to ocular treatment with Tobradex®, Maxidex® or levofloxacin/dexamethasone
10. Hypersensitivity to the study product or its excipients
11. Participation in other clinical studies within at least 5 half-lives of the Investigational Medicinal Product (IMP) used in the previous studies
12. Pregnancy or breastfeeding
40 Years
ALL
No
Sponsors
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NTC srl
INDUSTRY
Responsible Party
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Principal Investigators
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Francesco Bandello, Prof.
Role: PRINCIPAL_INVESTIGATOR
Ospedale San Raffaele IRCCS S.r.l.
Locations
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A.O.U. Osp. Riuniti Umberto I - G.M. Lancisi - G. Salesi - Università degli Studi di Ancona
Ancona, AN, Italy
Ospedale della Murgia "Fabio Perinei" di Altamura
Altamura, BA, Italy
A.O.U. Policlinico Consorziale di Bari
Bari, BA, Italy
ASL Bari - Ospedale "Di Venere" - Carbonara di Bari
Bari, BA, Italy
Cliniche Gavazzeni S.p.A. - Humanitas Gavazzeni di Bergamo
Bergamo, BG, Italy
A.O.U. di Bologna - Policlinico S. Orsola-Malpighi di Bologna
Bologna, BO, Italy
Policlinico S. Orsola-Malpighi di Bologna
Bologna, BO, Italy
ASST degli Spedali Civili di Brescia - P.O. Spedali Civili di Brescia
Brescia, BS, Italy
ASST Franciacorta - P.O. di Chiari
Chiari, BS, Italy
P.O. Ospedale Clinicizzato SS. Annunziata di Chieti
Chieti, CH, Italy
Ospedale Valduce di Como
Como, CO, Italy
A.O.U. Policlinico Vittorio Emanuele - P.O. Gaspare Rodolico - Università degli Studi di Catania
Catania, CT, Italy
Policlinico G.B. Morgagni di Catania - Casa di Cura s.r.l.
Catania, CT, Italy
A.O. Mater Domini di Catanzaro - Università degli Studi Magna Graecia di Catanzaro
Catanzaro, CZ, Italy
IRCCS Casa Sollievo della Sofferenza di San Giovanni Rotondo
San Giovanni Rotondo, FG, Italy
A.O.U. Careggi di Firenze
Florence, FI, Italy
IRCCS Ospedale Policlinico San Martino di Genova
Genova, GE, Italy
Ospedale Policlinico San Martino - Università degli Studi di Genova
Genova, GE, Italy
Fatebenefratelli - Ospedale "Sacra Famiglia" di Erba
Erba, LC, Italy
Az. USL Toscana Nord Ovest - Ospedale della Versilia
Lido di Camaiore, LU, Italy
AUSL Toscana Nord Ovest - P.O. San Luca di Lucca
San Filippo, LU, Italy
A.O.U. Policlinico "G. Martino" di Messina
Messina, ME, Italy
ASP di Messina - P.O. "Giuseppe Fogliani" di Milazzo
Milazzo, ME, Italy
ASST Ovest Milanese - Ospedale Civile di Legnano
Legnano, MI, Italy
IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, MI, Italy
Gruppo Multimedica - Ospedale San Giuseppe di Milano
Milan, MI, Italy
Ospedale San Raffaele IRCCS S.r.l.
Milan, MI, Italy
ASST Fatebenefratelli Sacco - Università degli Studi di Milano - Ospedale L. Sacco
Milan, MI, Italy
IRCCS Istituto Clinico Humanitas di Rozzano
Rozzano, MI, Italy
ASST di Melegnano e della Martesana - Ospedale di Vizzolo Predabissi
Vizzolo Predabissi, MI, Italy
A.O.U. Policlinico di Modena - Università degli Studi di Modena e Reggio Emilia
Modena, MO, Italy
Ospedale di Sassuolo
Sassuolo, MO, Italy
Centro Polispecialistico Monterosso di Carrara
Carrara, MS, Italy
A.O.U. Policlinico "P. Giaccone" di Palermo
Palermo, PA, Italy
A.O. "Ospedali Riuniti Villa Sofia-Cervello" di Palermo - P.O. "Villa Sofia" di Palermo
Palermo, PA, Italy
AUSL di Piacenza - Ospedale "Guglielmo da Saliceto" di Piacenza
Piacenza, PC, Italy
Az. ULSS 6 Euganea - Ospedali Riuniti Padova Sud - Ospedale Madre Teresa di Calcutta-Schiavonia
Monselice, PD), Italy
Az. ULSS 6 Euganea - Ospedale S. Antonio - Centro Oculistico San Paolo di Padova
Padua, PD, Italy
A.O. di Perugia - Ospedale S. Maria della Misericordia di Perugia
Perugia, PG, Italy
Fondazione IRCCS Policlinico S. Matteo - Università degli Studi di Pavia
Pavia, PV, Italy
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli di Reggio Calabria
Reggio Calabria, RC, Italy
Policlinico Universitario Campus Bio-medico di Roma
Roma, RM, Italy
Fondazione PTV Policlinico Tor Vergata
Roma, RM, Italy
A.O.U. Sant'Andrea di Roma
Roma, RM, Italy
IRCCS Fondazione G.B. Bietti di Roma
Roma, RM, Italy
ASL Roma 4 - Ospedale San Paolo di Civitavecchia
Civitavecchia, RN, Italy
Az. ULSS 5 Polesana - Ospedale "Santa Maria della Misericordia"
Rovigo, RO, Italy
A.O.U Città della Salute e della Scienza di Torino - Ospedale Molinette
Torino, TO, Italy
Az. Sanitaria Universitaria Integrata di Trieste - Ospedali Riuniti di Trieste - Ospedale Maggiore
Trieste, TS, Italy
Az. ULSS 2 Marca Trevigiana - Ospedale di Treviso
Treviso, TV, Italy
Az. Sanitaria Universitaria Integrata di Udine - P.O. Universitario "Santa Maria della Misericordia" diUdine
Udine, UD, Italy
Az. ULSS 7 Pedemontana - Ospedale San Bassiano di Bassano del Grappa
Bassano del Grappa, VI, Italy
Ospedale Sacro Cuore - Don Calabria di Negrar
Negrar, VR, Italy
A.O.U. Integrata di Verona - Ospedale Borgo Roma
Verona, VR, Italy
Az. Osp. di Rilievo Nazionale "A. Cardarelli" di Napoli
Napoli, , Italy
A.O.U. "Maggiore della Carità" di Novara
Novara, , Italy
A.O.U. Senese - Università degli Studi di Siena
Siena, , Italy
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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LEVODESA_04-2017
Identifier Type: -
Identifier Source: org_study_id
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