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

Novelty. Technology. Care. (NTC)

Status and phase: Completed; Phase 3

Conditions: Cataract

Treatments: Drug: Tobramycin + Dexamethasone; Drug: Levofloxacin + dexamethasone followed by dexamethasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT03739528

LEVODESA_04-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 808 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

808 participants in 2 patient groups

Levofloxacin + Dexamethasone followed by dexamethasone

Experimental group

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).

Treatment:

Drug: Levofloxacin + dexamethasone followed by dexamethasone

Tobramycin + dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: Tobramycin + Dexamethasone