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

Phase 3

Completed

• Conditions: Cataract
• Interventions: Drug: Levofloxacin + dexamethasone followed by dexamethasone; Drug: Tobramycin + Dexamethasone

• Registration Number: NCT03739528
• Lead Sponsor: NTC srl

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.

Study Timeline

• Study Start: 2018-09-03
• Study First Submitted: 2018-11-09
• Study First Submitted QC: 2018-11-13
• Study First Posted: 2018-11-14
• Primary Completion: 2018-12-19
• Study Completion: 2018-12-19
• Results First Submitted: 2020-05-29
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-04
• Last Update Submitted: 2020-08-04
• Results First Posted: 2020-08-18
• Last Update Posted: 2020-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 808

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levofloxacin + Dexamethasone followed by dexamethasone	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).
Tobramycin + dexamethasone	Tobramycin + Dexamethasone	Tobramycin + dexamethasone (14 days, 1 drop/4 times a day).

Primary Outcome Measures

Name	Time	Method
Number of Participants Without Signs of Anterior Chamber Inflammation	Day 15	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

Name	Time	Method
Number of Participants Without Signs of Anterior Ocular Chamber Inflammation	Day 0 (screening), 4, 8	Number of participants without signs of anterior chamber inflammation (sum of cells and flare score = 0).
Number of Participants With Endophthalmitis	Day 4, 8, 15	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.
Total Ocular Symptoms Score (TOSS)	Day 4, 8, 15	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	Day 4, 8, 15	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	During all the treatment until day 15	All rescue therapy used following cataract surgery is to be reported at all visits.
Conjunctival Hyperemia	Day 4, 8, 15	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).

Trial Locations

Locations (57)

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

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