Clinical trial NCT03739528: Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery
Official title: An International, Multicenter, Randomized, Blinded-assessor, Parallel-group Clinical Study Comparing Eye Drops of Combined LEvofloxAcin + DExamethasone foR 7 Days Followed by Dexamethasone Alone for an Additional 7 Days vs. Tobramycin + Dexamethasone for 14 Days for the Prevention and Treatment of Inflammation and Prevention of Infection Associated With Cataract Surgery in Adults - LEADER 7
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Lead sponsor: NTC srl
Sponsor class: INDUSTRY
First posted: 2018-11-14
Enrollment: 808
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, parallel-group study
Primary purpose: PREVENTION

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.

Detailed description: In clinical practice, topical treatment following cataract surgery is frequently administered using a combination between an antibiotic and a corticosteroid to promote patient adherence to therapy and to obtain both prevention of infection and treatment of post-surgical inflammation.

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.

Eligibility criteria: Inclusion Criteria prior to surgery:

1. Signed written informed consent
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

   Inclusion criteria following surgery:
7. Surgery completed without complications

Exclusion Criteria:

1. Ocular conditions that at the discretion of the Investigator may interfere with the efficacy and/or safety evaluations
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

Primary outcomes:
measure: Number of Participants Without Signs of Anterior Chamber Inflammation
timeFrame: Day 15
Secondary outcomes:
measure: Number of Participants With Endophthalmitis
timeFrame: Day 4, 8, 15
measure: Number of Participants Without Signs of Anterior Ocular Chamber Inflammation
timeFrame: Day 0 (screening), 4, 8
measure: Conjunctival Hyperemia
timeFrame: Day 4, 8, 15
measure: Total Ocular Symptoms Score (TOSS)
timeFrame: Day 4, 8, 15
measure: Ocular Pain/Discomfort: 4-point Scale
timeFrame: Day 4, 8, 15
measure: Use of Rescue Therapy
timeFrame: During all the treatment until day 15
Other outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: At day 0 (screening) and at day 4, 8, 15
measure: Visual Acuity
timeFrame: At day 0 (screening) and at day 15
measure: Adverse Events
timeFrame: During all the treatment until day 15
measure: Global Evaluation of Local Tolerability
timeFrame: Day 4, 8, 15
measure: Burning, Stinging, Blurred Vision
timeFrame: Day 4, 8, 15
measure: Assessment of Patient Diary (Compliance)
timeFrame: Day 15
Locations:
city: Ancona
country: Italy
facility: A.O.U. Osp. Riuniti Umberto I - G.M. Lancisi - G. Salesi - Università degli Studi di Ancona
state: AN
city: Altamura
country: Italy
facility: Ospedale della Murgia "Fabio Perinei" di Altamura
state: BA
city: Bari
country: Italy
facility: A.O.U. Policlinico Consorziale di Bari
state: BA
city: Bari
country: Italy
facility: ASL Bari - Ospedale "Di Venere" - Carbonara di Bari
state: BA
city: Bergamo
country: Italy
facility: Cliniche Gavazzeni S.p.A. - Humanitas Gavazzeni di Bergamo
state: BG
city: Bologna
country: Italy
facility: A.O.U. di Bologna - Policlinico S. Orsola-Malpighi di Bologna
state: BO
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi di Bologna
state: BO
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia - P.O. Spedali Civili di Brescia
state: BS
city: Chiari
country: Italy
facility: ASST Franciacorta - P.O. di Chiari
state: BS
city: Chieti
country: Italy
facility: P.O. Ospedale Clinicizzato SS. Annunziata di Chieti
state: CH
city: Como
country: Italy
facility: Ospedale Valduce di Como
state: CO
city: Catania
country: Italy
facility: A.O.U. Policlinico Vittorio Emanuele - P.O. Gaspare Rodolico - Università degli Studi di Catania
state: CT
city: Catania
country: Italy
facility: Policlinico G.B. Morgagni di Catania - Casa di Cura s.r.l.
state: CT
city: Catanzaro
country: Italy
facility: A.O. Mater Domini di Catanzaro - Università degli Studi Magna Graecia di Catanzaro
state: CZ
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Casa Sollievo della Sofferenza di San Giovanni Rotondo
state: FG
city: Firenze
country: Italy
facility: A.O.U. Careggi di Firenze
state: FI
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino di Genova
state: GE
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino - Università degli Studi di Genova
state: GE
city: Erba
country: Italy
facility: Fatebenefratelli - Ospedale "Sacra Famiglia" di Erba
state: LC
city: Lido Di Camaiore
country: Italy
facility: Az. USL Toscana Nord Ovest - Ospedale della Versilia
state: LU
city: San Filippo
country: Italy
facility: AUSL Toscana Nord Ovest - P.O. San Luca di Lucca
state: LU
city: Messina
country: Italy
facility: A.O.U. Policlinico "G. Martino" di Messina
state: ME
city: Milazzo
country: Italy
facility: ASP di Messina - P.O. "Giuseppe Fogliani" di Milazzo
state: ME
city: Legnano
country: Italy
facility: ASST Ovest Milanese - Ospedale Civile di Legnano
state: MI
city: Milano
country: Italy
facility: IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
state: MI
city: Milano
country: Italy
facility: Gruppo Multimedica - Ospedale San Giuseppe di Milano
state: MI
city: Milano
country: Italy
facility: Ospedale San Raffaele IRCCS S.r.l.
state: MI
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco - Università degli Studi di Milano - Ospedale L. Sacco
state: MI
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas di Rozzano
state: MI
city: Vizzolo Predabissi
country: Italy
facility: ASST di Melegnano e della Martesana - Ospedale di Vizzolo Predabissi
state: MI
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena - Università degli Studi di Modena e Reggio Emilia
state: MO
city: Sassuolo
country: Italy
facility: Ospedale di Sassuolo
state: MO
city: Carrara
country: Italy
facility: Centro Polispecialistico Monterosso di Carrara
state: MS
city: Palermo
country: Italy
facility: A.O.U. Policlinico "P. Giaccone" di Palermo
state: PA
city: Palermo
country: Italy
facility: A.O. "Ospedali Riuniti Villa Sofia-Cervello" di Palermo - P.O. "Villa Sofia" di Palermo
state: PA
city: Piacenza
country: Italy
facility: AUSL di Piacenza - Ospedale "Guglielmo da Saliceto" di Piacenza
state: PC
city: Monselice
country: Italy
facility: Az. ULSS 6 Euganea - Ospedali Riuniti Padova Sud - Ospedale Madre Teresa di Calcutta-Schiavonia
state: PD)
city: Padova
country: Italy
facility: Az. ULSS 6 Euganea - Ospedale S. Antonio - Centro Oculistico San Paolo di Padova
state: PD
city: Perugia
country: Italy
facility: A.O. di Perugia - Ospedale S. Maria della Misericordia di Perugia
state: PG
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico S. Matteo - Università degli Studi di Pavia
state: PV
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli di Reggio Calabria
state: RC
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-medico di Roma
state: RM
city: Roma
country: Italy
facility: Fondazione PTV Policlinico Tor Vergata
state: RM
city: Roma
country: Italy
facility: A.O.U. Sant'Andrea di Roma
state: RM
city: Roma
country: Italy
facility: IRCCS Fondazione G.B. Bietti di Roma
state: RM
city: Civitavecchia
country: Italy
facility: ASL Roma 4 - Ospedale San Paolo di Civitavecchia
state: RN
city: Rovigo
country: Italy
facility: Az. ULSS 5 Polesana - Ospedale "Santa Maria della Misericordia"
state: RO
city: Torino
country: Italy
facility: A.O.U Città della Salute e della Scienza di Torino - Ospedale Molinette
state: TO
city: Trieste
country: Italy
facility: Az. Sanitaria Universitaria Integrata di Trieste - Ospedali Riuniti di Trieste - Ospedale Maggiore
state: TS
city: Treviso
country: Italy
facility: Az. ULSS 2 Marca Trevigiana - Ospedale di Treviso
state: TV
city: Udine
country: Italy
facility: Az. Sanitaria Universitaria Integrata di Udine - P.O. Universitario "Santa Maria della Misericordia" diUdine
state: UD
city: Bassano Del Grappa
country: Italy
facility: Az. ULSS 7 Pedemontana - Ospedale San Bassiano di Bassano del Grappa
state: VI
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore - Don Calabria di Negrar
state: VR
city: Verona
country: Italy
facility: A.O.U. Integrata di Verona - Ospedale Borgo Roma
state: VR
city: Napoli
country: Italy
facility: Az. Osp. di Rilievo Nazionale "A. Cardarelli" di Napoli
city: Novara
country: Italy
facility: A.O.U. "Maggiore della Carità" di Novara
city: Siena
country: Italy
facility: A.O.U. Senese - Università degli Studi di Siena
Study officials:
affiliation: Ospedale San Raffaele IRCCS S.r.l.
name: Francesco Bandello, Prof.
role: PRINCIPAL_INVESTIGATOR
References: