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CataractPhase 3LEADER7NCT03739528

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

A Phase 3 study testing Levofloxacin + dexamethasone followed by dexamethasone and Tobramycin + Dexamethasone in people with Cataract, run by NTC srl at 57 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Cataract
What is being tested?
Levofloxacin + dexamethasone followed by dexamethasone and Tobramycin + Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
808 participants
Where
57 sitesItaly
Study dates
3 Sep 2018to 19 Dec 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

57 sites in 1 country.

57 sites in 1 country

Italy57 sites

  • Ospedale della Murgia "Fabio Perinei" di Altamura

    Altamura, BA, 70022

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

    Ancona, AN, 60126

  • A.O.U. Policlinico Consorziale di Bari

    Bari, BA, 70125

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

    Bari, BA, 70131

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

    Bassano del Grappa, VI, 36061

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

    Bergamo, BG, 24125

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

    Bologna, BO, 40138

  • Policlinico S. Orsola-Malpighi di Bologna

    Bologna, BO, 40138

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

    Brescia, BS, 25123

  • Centro Polispecialistico Monterosso di Carrara

    Carrara, MS, 54033

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

    Catania, CT, 95123

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

    Catania, CT, 95125

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

    Catanzaro, CZ, 88100

  • ASST Franciacorta - P.O. di Chiari

    Chiari, BS, 25032

  • P.O. Ospedale Clinicizzato SS. Annunziata di Chieti

    Chieti, CH, 66100

  • ASL Roma 4 - Ospedale San Paolo di Civitavecchia

    Civitavecchia, RN, 00053

  • Ospedale Valduce di Como

    Como, CO, 22100

  • Fatebenefratelli - Ospedale "Sacra Famiglia" di Erba

    Erba, LC, 22036

  • A.O.U. Careggi di Firenze

    Florence, FI, 50139

  • IRCCS Ospedale Policlinico San Martino di Genova

    Genova, GE, 16132

  • Ospedale Policlinico San Martino - Università degli Studi di Genova

    Genova, GE, 16132

  • ASST Ovest Milanese - Ospedale Civile di Legnano

    Legnano, MI, 20025

  • Az. USL Toscana Nord Ovest - Ospedale della Versilia

    Lido di Camaiore, LU, 55049

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

    Messina, ME, 98124

  • IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

    Milan, MI, 20122

  • Gruppo Multimedica - Ospedale San Giuseppe di Milano

    Milan, MI, 20123

  • Ospedale San Raffaele IRCCS S.r.l.

    Milan, MI, 20132

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

    Milan, MI, 20157

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

    Milazzo, ME, 98057

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

    Modena, MO, 41125

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

    Monselice, PD), 35043

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

    Naples, 80131

  • Ospedale Sacro Cuore - Don Calabria di Negrar

    Negrar, VR, 37024

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

    Novara, 28100

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

    Padova, PD, 35100

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

    Palermo, PA, 90127

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

    Palermo, PA, 90146

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

    Pavia, PV, 27100

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

    Perugia, PG, 06156

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

    Piacenza, PC, Piacenza

  • Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli di Reggio Calabria

    Reggio Calabria, RC, 89124

  • Policlinico Universitario Campus Bio-medico di Roma

    Roma, RM, 00128

  • Fondazione PTV Policlinico Tor Vergata

    Roma, RM, 00133

  • A.O.U. Sant'Andrea di Roma

    Roma, RM, 00189

  • IRCCS Fondazione G.B. Bietti di Roma

    Roma, RM, 00198

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

    Rovigo, RO, 45100

  • IRCCS Istituto Clinico Humanitas di Rozzano

    Rozzano, MI, 20089

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

    San Filippo, LU, 56123

  • IRCCS Casa Sollievo della Sofferenza di San Giovanni Rotondo

    San Giovanni Rotondo, FG, 71013

  • Ospedale di Sassuolo

    Sassuolo, MO, 41049

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

    Siena, 53100

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

    Torino, TO, 10126

  • Az. ULSS 2 Marca Trevigiana - Ospedale di Treviso

    Treviso, TV, 31100

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

    Trieste, TS, 34129

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

    Udine, UD, 33100

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

    Verona, VR, 37134

  • ASST di Melegnano e della Martesana - Ospedale di Vizzolo Predabissi

    Vizzolo Predabissi, MI, 20077

Other trials in Italy

About this study

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

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.

Read the 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.

Conditions
Cataract
Being tested
Levofloxacin + dexamethasone followed by dexamethasone, Tobramycin + Dexamethasone
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Levofloxacin + dexamethasone followed by dexamethasoneDrug

    Also called Levofloxacin + dexamethasone followed by Maxidex

    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 + DexamethasoneDrug

    Also called Tobradex

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

Study groups in NCT03739528
Study groupRoleWhat they receive
Levofloxacin + Dexamethasone followed by dexamethasoneExperimentalLevofloxacin 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).
Receives: Drug: Levofloxacin + dexamethasone followed by dexamethasone
Tobramycin + dexamethasoneActive comparatorTobramycin + dexamethasone (14 days, 1 drop/4 times a day).
Receives: Drug: Tobramycin + Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%.

    Measured: Day 15

Secondary outcomes (6)

  1. 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.

    Measured: Day 4, 8, 15

  2. 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).

    Measured: Day 0 (screening), 4, 8

  3. 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).

    Measured: Day 4, 8, 15

  4. 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.

    Measured: Day 4, 8, 15

  5. 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).

    Measured: Day 4, 8, 15

  6. Use of Rescue Therapy

    All rescue therapy used following cataract surgery is to be reported at all visits.

    Measured: During all the treatment until day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2018
  2. Study start3 Sep 2018
  3. Primary completion19 Dec 2018
  4. Study completion19 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
A randomized, parallel-group study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
808 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03739528
Sponsor's protocol ID
LEVODESA_04-2017
Acronym
LEADER7
Status last verified
Aug 2020
First submitted
9 Nov 2018
Last updated
18 Aug 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Levofloxacin + dexamethasone followed by dexamethasone and Tobramycin + Dexamethasone in people with Cataract, run by NTC srl at 57 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Without Signs of Anterior Chamber Inflammation (time frame: Day 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03739528.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.

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