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Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery (LEADER7)

Primary Purpose

Cataract

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Levofloxacin + dexamethasone followed by dexamethasone
Tobramycin + Dexamethasone
Sponsored by
NTC srl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cataract

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • A.O.U. Osp. Riuniti Umberto I - G.M. Lancisi - G. Salesi - Università degli Studi di Ancona
  • Ospedale della Murgia "Fabio Perinei" di Altamura
  • A.O.U. Policlinico Consorziale di Bari
  • ASL Bari - Ospedale "Di Venere" - Carbonara di Bari
  • Cliniche Gavazzeni S.p.A. - Humanitas Gavazzeni di Bergamo
  • A.O.U. di Bologna - Policlinico S. Orsola-Malpighi di Bologna
  • Policlinico S. Orsola-Malpighi di Bologna
  • ASST degli Spedali Civili di Brescia - P.O. Spedali Civili di Brescia
  • ASST Franciacorta - P.O. di Chiari
  • P.O. Ospedale Clinicizzato SS. Annunziata di Chieti
  • Ospedale Valduce di Como
  • A.O.U. Policlinico Vittorio Emanuele - P.O. Gaspare Rodolico - Università degli Studi di Catania
  • Policlinico G.B. Morgagni di Catania - Casa di Cura s.r.l.
  • A.O. Mater Domini di Catanzaro - Università degli Studi Magna Graecia di Catanzaro
  • IRCCS Casa Sollievo della Sofferenza di San Giovanni Rotondo
  • A.O.U. Careggi di Firenze
  • IRCCS Ospedale Policlinico San Martino di Genova
  • Ospedale Policlinico San Martino - Università degli Studi di Genova
  • Fatebenefratelli - Ospedale "Sacra Famiglia" di Erba
  • Az. USL Toscana Nord Ovest - Ospedale della Versilia
  • AUSL Toscana Nord Ovest - P.O. San Luca di Lucca
  • A.O.U. Policlinico "G. Martino" di Messina
  • ASP di Messina - P.O. "Giuseppe Fogliani" di Milazzo
  • ASST Ovest Milanese - Ospedale Civile di Legnano
  • IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
  • Gruppo Multimedica - Ospedale San Giuseppe di Milano
  • Ospedale San Raffaele IRCCS S.r.l.
  • ASST Fatebenefratelli Sacco - Università degli Studi di Milano - Ospedale L. Sacco
  • IRCCS Istituto Clinico Humanitas di Rozzano
  • ASST di Melegnano e della Martesana - Ospedale di Vizzolo Predabissi
  • A.O.U. Policlinico di Modena - Università degli Studi di Modena e Reggio Emilia
  • Ospedale di Sassuolo
  • Centro Polispecialistico Monterosso di Carrara
  • A.O.U. Policlinico "P. Giaccone" di Palermo
  • A.O. "Ospedali Riuniti Villa Sofia-Cervello" di Palermo - P.O. "Villa Sofia" di Palermo
  • AUSL di Piacenza - Ospedale "Guglielmo da Saliceto" di Piacenza
  • Az. ULSS 6 Euganea - Ospedali Riuniti Padova Sud - Ospedale Madre Teresa di Calcutta-Schiavonia
  • Az. ULSS 6 Euganea - Ospedale S. Antonio - Centro Oculistico San Paolo di Padova
  • A.O. di Perugia - Ospedale S. Maria della Misericordia di Perugia
  • Fondazione IRCCS Policlinico S. Matteo - Università degli Studi di Pavia
  • Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli di Reggio Calabria
  • Policlinico Universitario Campus Bio-medico di Roma
  • Fondazione PTV Policlinico Tor Vergata
  • A.O.U. Sant'Andrea di Roma
  • IRCCS Fondazione G.B. Bietti di Roma
  • ASL Roma 4 - Ospedale San Paolo di Civitavecchia
  • Az. ULSS 5 Polesana - Ospedale "Santa Maria della Misericordia"
  • A.O.U Città della Salute e della Scienza di Torino - Ospedale Molinette
  • Az. Sanitaria Universitaria Integrata di Trieste - Ospedali Riuniti di Trieste - Ospedale Maggiore
  • Az. ULSS 2 Marca Trevigiana - Ospedale di Treviso
  • Az. Sanitaria Universitaria Integrata di Udine - P.O. Universitario "Santa Maria della Misericordia" diUdine
  • Az. ULSS 7 Pedemontana - Ospedale San Bassiano di Bassano del Grappa
  • Ospedale Sacro Cuore - Don Calabria di Negrar
  • A.O.U. Integrata di Verona - Ospedale Borgo Roma
  • Az. Osp. di Rilievo Nazionale "A. Cardarelli" di Napoli
  • A.O.U. "Maggiore della Carità" di Novara
  • A.O.U. Senese - Università degli Studi di Siena

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Levofloxacin + Dexamethasone followed by dexamethasone

Tobramycin + dexamethasone

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

Number of Participants With Endophthalmitis
The number of participants with endophthalmitis after administration of study treatment in the study was assessed and reported. Diagnosis of endophthalmitis is based on clinical evaluation of signs and symptoms (such as swollen eyelids, ocular pain, conjunctival hyperemia, decreased visual acuity, opaque vitreous) through slit lamp examination, and microbiological tests on conjunctival or corneal swabs.
Number of Participants Without Signs of Anterior Ocular Chamber Inflammation
Number of participants without signs of anterior chamber inflammation (sum of cells and flare score = 0).
Conjunctival Hyperemia
Conjunctival hyperemia was evaluated with slit lamp and results provided as a score as follows: 0 = absence of inflammation, 1 = mild inflammation (some vessels injected), 2 = moderate inflammation (diffuse injection of vessels, but individual vessels are still discernable) 3 = severe inflammation (intense injection of vessels, individual vessels not easily discernable).
Total Ocular Symptoms Score (TOSS)
The TOSS is a patient-reported evaluation in the TOSS Questionnaire of 3 ocular symptoms: itching/burning, hyperemia of conjunctiva and tearing. A score was given in the presence of symptoms: 0 = none, 1 = mild, 2 = moderate, 3 = severe.
Ocular Pain/Discomfort: 4-point Scale
Overall ocular pain and discomfort was evaluated by the subject on a 4-point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe).
Use of Rescue Therapy
All rescue therapy used following cataract surgery is to be reported at all visits.

Full Information

First Posted
November 9, 2018
Last Updated
August 4, 2020
Sponsor
NTC srl
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1. Study Identification

Unique Protocol Identification Number
NCT03739528
Brief Title
Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery
Acronym
LEADER7
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
December 19, 2018 (Actual)
Study Completion Date
December 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NTC srl

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A randomized, parallel-group study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
808 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levofloxacin + Dexamethasone followed by dexamethasone
Arm Type
Experimental
Arm Description
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).
Arm Title
Tobramycin + dexamethasone
Arm Type
Active Comparator
Arm Description
Tobramycin + dexamethasone (14 days, 1 drop/4 times a day).
Intervention Type
Drug
Intervention Name(s)
Levofloxacin + dexamethasone followed by dexamethasone
Other Intervention Name(s)
Levofloxacin + dexamethasone followed by Maxidex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Tobramycin + Dexamethasone
Other Intervention Name(s)
Tobradex
Intervention Description
Tobramycin + dexamethasone ophthalmic suspension (Tobradex®) for 14 days, 1 drop - 4 times a day.
Primary Outcome Measure Information:
Title
Number of Participants Without Signs of Anterior Chamber Inflammation
Description
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%.
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Number of Participants With Endophthalmitis
Description
The number of participants with endophthalmitis after administration of study treatment in the study was assessed and reported. Diagnosis of endophthalmitis is based on clinical evaluation of signs and symptoms (such as swollen eyelids, ocular pain, conjunctival hyperemia, decreased visual acuity, opaque vitreous) through slit lamp examination, and microbiological tests on conjunctival or corneal swabs.
Time Frame
Day 4, 8, 15
Title
Number of Participants Without Signs of Anterior Ocular Chamber Inflammation
Description
Number of participants without signs of anterior chamber inflammation (sum of cells and flare score = 0).
Time Frame
Day 0 (screening), 4, 8
Title
Conjunctival Hyperemia
Description
Conjunctival hyperemia was evaluated with slit lamp and results provided as a score as follows: 0 = absence of inflammation, 1 = mild inflammation (some vessels injected), 2 = moderate inflammation (diffuse injection of vessels, but individual vessels are still discernable) 3 = severe inflammation (intense injection of vessels, individual vessels not easily discernable).
Time Frame
Day 4, 8, 15
Title
Total Ocular Symptoms Score (TOSS)
Description
The TOSS is a patient-reported evaluation in the TOSS Questionnaire of 3 ocular symptoms: itching/burning, hyperemia of conjunctiva and tearing. A score was given in the presence of symptoms: 0 = none, 1 = mild, 2 = moderate, 3 = severe.
Time Frame
Day 4, 8, 15
Title
Ocular Pain/Discomfort: 4-point Scale
Description
Overall ocular pain and discomfort was evaluated by the subject on a 4-point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe).
Time Frame
Day 4, 8, 15
Title
Use of Rescue Therapy
Description
All rescue therapy used following cataract surgery is to be reported at all visits.
Time Frame
During all the treatment until day 15
Other Pre-specified Outcome Measures:
Title
Intraocular Pressure (IOP)
Description
IOP is measured using a tonometer. IOP is measured as mmHg; normal intraocular pressures average between 12-22 mm Hg.
Time Frame
At day 0 (screening) and at day 4, 8, 15
Title
Visual Acuity
Description
Visual acuity was assessed as per local clinical practice, i.e. with the Snellen (feet) or the ETDRS (meter) chart. Visual acuity was then analysed using decimal unit. Decimal score is the decimal expression of the Snellen (feet) or the ETDRS (meter) charts in which the numerator indicates the distance from the chart and the denominator indicates the size of the smallest line that can be read. Decimal values were provided directly from the investigator or computed as a result of the Snellen or ETDRS fraction. Generally decimal values from 0.01 to 0.10 indicate severe vision loss; decimal values from 0.125 to 0.25 indicate moderate vision loss; decimal values from 0.32 to 0.63 indicate mild vision loss; decimal values from 0.8 to 1.6 indicate normal vision. Lower decimal values correspond to a reduced visual acuity and worst outcomes, while higher decimal values indicate an improved visual acuity and better outcomes.
Time Frame
At day 0 (screening) and at day 15
Title
Adverse Events
Description
Adverse events were described according to System Organ Classes (SOC) and Preferred Terms (PT) using the Medical Dictionary for Regulatory Activities (MedDRA) and were presented by treatment group.
Time Frame
During all the treatment until day 15
Title
Global Evaluation of Local Tolerability
Description
Global evaluation was evaluated on a 4-point scale: 0 = no intolerability, 1 = mild intolerability, 2 = moderate intolerability, 3 = maximum intolerability.
Time Frame
Day 4, 8, 15
Title
Burning, Stinging, Blurred Vision
Description
Burning, stinging, blurred vision were evaluated on a 4-point scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe.
Time Frame
Day 4, 8, 15
Title
Assessment of Patient Diary (Compliance)
Description
Treatment compliance is derived from the number of instillations each day during the study treatment exposure
Time Frame
Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria prior to surgery: 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 Inclusion criteria following surgery: Surgery completed without complications Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Bandello, Prof.
Organizational Affiliation
Ospedale San Raffaele IRCCS S.r.l.
Official's Role
Principal Investigator
Facility Information:
Facility Name
A.O.U. Osp. Riuniti Umberto I - G.M. Lancisi - G. Salesi - Università degli Studi di Ancona
City
Ancona
State/Province
AN
ZIP/Postal Code
60126
Country
Italy
Facility Name
Ospedale della Murgia "Fabio Perinei" di Altamura
City
Altamura
State/Province
BA
ZIP/Postal Code
70022
Country
Italy
Facility Name
A.O.U. Policlinico Consorziale di Bari
City
Bari
State/Province
BA
ZIP/Postal Code
70125
Country
Italy
Facility Name
ASL Bari - Ospedale "Di Venere" - Carbonara di Bari
City
Bari
State/Province
BA
ZIP/Postal Code
70131
Country
Italy
Facility Name
Cliniche Gavazzeni S.p.A. - Humanitas Gavazzeni di Bergamo
City
Bergamo
State/Province
BG
ZIP/Postal Code
24125
Country
Italy
Facility Name
A.O.U. di Bologna - Policlinico S. Orsola-Malpighi di Bologna
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
Policlinico S. Orsola-Malpighi di Bologna
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Facility Name
ASST degli Spedali Civili di Brescia - P.O. Spedali Civili di Brescia
City
Brescia
State/Province
BS
ZIP/Postal Code
25123
Country
Italy
Facility Name
ASST Franciacorta - P.O. di Chiari
City
Chiari
State/Province
BS
ZIP/Postal Code
25032
Country
Italy
Facility Name
P.O. Ospedale Clinicizzato SS. Annunziata di Chieti
City
Chieti
State/Province
CH
ZIP/Postal Code
66100
Country
Italy
Facility Name
Ospedale Valduce di Como
City
Como
State/Province
CO
ZIP/Postal Code
22100
Country
Italy
Facility Name
A.O.U. Policlinico Vittorio Emanuele - P.O. Gaspare Rodolico - Università degli Studi di Catania
City
Catania
State/Province
CT
ZIP/Postal Code
95123
Country
Italy
Facility Name
Policlinico G.B. Morgagni di Catania - Casa di Cura s.r.l.
City
Catania
State/Province
CT
ZIP/Postal Code
95125
Country
Italy
Facility Name
A.O. Mater Domini di Catanzaro - Università degli Studi Magna Graecia di Catanzaro
City
Catanzaro
State/Province
CZ
ZIP/Postal Code
88100
Country
Italy
Facility Name
IRCCS Casa Sollievo della Sofferenza di San Giovanni Rotondo
City
San Giovanni Rotondo
State/Province
FG
ZIP/Postal Code
71013
Country
Italy
Facility Name
A.O.U. Careggi di Firenze
City
Firenze
State/Province
FI
ZIP/Postal Code
50139
Country
Italy
Facility Name
IRCCS Ospedale Policlinico San Martino di Genova
City
Genova
State/Province
GE
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale Policlinico San Martino - Università degli Studi di Genova
City
Genova
State/Province
GE
ZIP/Postal Code
16132
Country
Italy
Facility Name
Fatebenefratelli - Ospedale "Sacra Famiglia" di Erba
City
Erba
State/Province
LC
ZIP/Postal Code
22036
Country
Italy
Facility Name
Az. USL Toscana Nord Ovest - Ospedale della Versilia
City
Lido Di Camaiore
State/Province
LU
ZIP/Postal Code
55049
Country
Italy
Facility Name
AUSL Toscana Nord Ovest - P.O. San Luca di Lucca
City
San Filippo
State/Province
LU
ZIP/Postal Code
56123
Country
Italy
Facility Name
A.O.U. Policlinico "G. Martino" di Messina
City
Messina
State/Province
ME
ZIP/Postal Code
98124
Country
Italy
Facility Name
ASP di Messina - P.O. "Giuseppe Fogliani" di Milazzo
City
Milazzo
State/Province
ME
ZIP/Postal Code
98057
Country
Italy
Facility Name
ASST Ovest Milanese - Ospedale Civile di Legnano
City
Legnano
State/Province
MI
ZIP/Postal Code
20025
Country
Italy
Facility Name
IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
City
Milano
State/Province
MI
ZIP/Postal Code
20122
Country
Italy
Facility Name
Gruppo Multimedica - Ospedale San Giuseppe di Milano
City
Milano
State/Province
MI
ZIP/Postal Code
20123
Country
Italy
Facility Name
Ospedale San Raffaele IRCCS S.r.l.
City
Milano
State/Province
MI
ZIP/Postal Code
20132
Country
Italy
Facility Name
ASST Fatebenefratelli Sacco - Università degli Studi di Milano - Ospedale L. Sacco
City
Milano
State/Province
MI
ZIP/Postal Code
20157
Country
Italy
Facility Name
IRCCS Istituto Clinico Humanitas di Rozzano
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
Facility Name
ASST di Melegnano e della Martesana - Ospedale di Vizzolo Predabissi
City
Vizzolo Predabissi
State/Province
MI
ZIP/Postal Code
20077
Country
Italy
Facility Name
A.O.U. Policlinico di Modena - Università degli Studi di Modena e Reggio Emilia
City
Modena
State/Province
MO
ZIP/Postal Code
41125
Country
Italy
Facility Name
Ospedale di Sassuolo
City
Sassuolo
State/Province
MO
ZIP/Postal Code
41049
Country
Italy
Facility Name
Centro Polispecialistico Monterosso di Carrara
City
Carrara
State/Province
MS
ZIP/Postal Code
54033
Country
Italy
Facility Name
A.O.U. Policlinico "P. Giaccone" di Palermo
City
Palermo
State/Province
PA
ZIP/Postal Code
90127
Country
Italy
Facility Name
A.O. "Ospedali Riuniti Villa Sofia-Cervello" di Palermo - P.O. "Villa Sofia" di Palermo
City
Palermo
State/Province
PA
ZIP/Postal Code
90146
Country
Italy
Facility Name
AUSL di Piacenza - Ospedale "Guglielmo da Saliceto" di Piacenza
City
Piacenza
State/Province
PC
ZIP/Postal Code
Piacenza
Country
Italy
Facility Name
Az. ULSS 6 Euganea - Ospedali Riuniti Padova Sud - Ospedale Madre Teresa di Calcutta-Schiavonia
City
Monselice
State/Province
PD)
ZIP/Postal Code
35043
Country
Italy
Facility Name
Az. ULSS 6 Euganea - Ospedale S. Antonio - Centro Oculistico San Paolo di Padova
City
Padova
State/Province
PD
ZIP/Postal Code
35100
Country
Italy
Facility Name
A.O. di Perugia - Ospedale S. Maria della Misericordia di Perugia
City
Perugia
State/Province
PG
ZIP/Postal Code
06156
Country
Italy
Facility Name
Fondazione IRCCS Policlinico S. Matteo - Università degli Studi di Pavia
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Facility Name
Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli di Reggio Calabria
City
Reggio Calabria
State/Province
RC
ZIP/Postal Code
89124
Country
Italy
Facility Name
Policlinico Universitario Campus Bio-medico di Roma
City
Roma
State/Province
RM
ZIP/Postal Code
00128
Country
Italy
Facility Name
Fondazione PTV Policlinico Tor Vergata
City
Roma
State/Province
RM
ZIP/Postal Code
00133
Country
Italy
Facility Name
A.O.U. Sant'Andrea di Roma
City
Roma
State/Province
RM
ZIP/Postal Code
00189
Country
Italy
Facility Name
IRCCS Fondazione G.B. Bietti di Roma
City
Roma
State/Province
RM
ZIP/Postal Code
00198
Country
Italy
Facility Name
ASL Roma 4 - Ospedale San Paolo di Civitavecchia
City
Civitavecchia
State/Province
RN
ZIP/Postal Code
00053
Country
Italy
Facility Name
Az. ULSS 5 Polesana - Ospedale "Santa Maria della Misericordia"
City
Rovigo
State/Province
RO
ZIP/Postal Code
45100
Country
Italy
Facility Name
A.O.U Città della Salute e della Scienza di Torino - Ospedale Molinette
City
Torino
State/Province
TO
ZIP/Postal Code
10126
Country
Italy
Facility Name
Az. Sanitaria Universitaria Integrata di Trieste - Ospedali Riuniti di Trieste - Ospedale Maggiore
City
Trieste
State/Province
TS
ZIP/Postal Code
34129
Country
Italy
Facility Name
Az. ULSS 2 Marca Trevigiana - Ospedale di Treviso
City
Treviso
State/Province
TV
ZIP/Postal Code
31100
Country
Italy
Facility Name
Az. Sanitaria Universitaria Integrata di Udine - P.O. Universitario "Santa Maria della Misericordia" diUdine
City
Udine
State/Province
UD
ZIP/Postal Code
33100
Country
Italy
Facility Name
Az. ULSS 7 Pedemontana - Ospedale San Bassiano di Bassano del Grappa
City
Bassano Del Grappa
State/Province
VI
ZIP/Postal Code
36061
Country
Italy
Facility Name
Ospedale Sacro Cuore - Don Calabria di Negrar
City
Negrar
State/Province
VR
ZIP/Postal Code
37024
Country
Italy
Facility Name
A.O.U. Integrata di Verona - Ospedale Borgo Roma
City
Verona
State/Province
VR
ZIP/Postal Code
37134
Country
Italy
Facility Name
Az. Osp. di Rilievo Nazionale "A. Cardarelli" di Napoli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
A.O.U. "Maggiore della Carità" di Novara
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
A.O.U. Senese - Università degli Studi di Siena
City
Siena
ZIP/Postal Code
53100
Country
Italy

12. IPD Sharing Statement

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

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