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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
808
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 ophthalmic suspension (Tobradex®) for 14 days, 1 drop - 4 times a day.
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%.
Time frame: Day 15
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.
Time frame: Day 4, 8, 15
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).
Time frame: Day 0 (screening), 4, 8
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).
Time frame: Day 4, 8, 15
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.
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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
...and 47 more locations
Time frame: Day 4, 8, 15
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).
Time frame: Day 4, 8, 15
Use of Rescue Therapy
All rescue therapy used following cataract surgery is to be reported at all visits.
Time frame: During all the treatment until day 15