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

• Status: Completed
• Trial end date: 2018-12-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NTC srl
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Levofloxacin; Ofloxacin; Tobramycin

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