Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery

• Status: Completed
• Trial end date: 2018-12-06
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the penetration of levofloxacin and dexamethasone 21-phosphate into the aqueous humour after ocular administration in combination or as single active ingredients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. Written informed consent

2. Male or female patients, aged ≥40 years

3. Patient undergoing phacoemulsification

4. Corneal thickness between 450 μm and 600 μm as measured by means of pachymetry

5. Corneal integrity confirmed by means of fluorescein test

6. Adequate pupil dilation assessed at screening

7. Female patients of childbearing potential must have a negative pregnancy test

8. Ability to fully understand all study procedures

Exclusion Criteria:

1. Corneal epithelium integrity not confirmed by fluorescein test

2. History of corneal disease or dystrophy

3. History of ocular trauma with corneal damage

4. History of acute ocular inflammation (including uveitis) in the 6 months prior to screening

5. Previous ocular surgery (including laser treatment)

6. Glaucoma

7. Treatment with an ophthalmic investigational drug in the 3 months prior to screening

8. Treatment with any topical ocular drug within 12 hours before start of cataract surgery other than study drugs and instillation of topical anaesthetic within 10 minutes before start of surgery

9. Treatment with any topical steroid or antibiotic drug in the 7 days prior to cataract surgery

10. Treatment with any systemic steroid or antibiotic drug in the 7 days prior to cataract surgery

11. Known hypersensitivity to levofloxacin, other fluoroquinolones or dexamethasone

12. Pregnant or lactating women

13. Patients who have received any investigational drug during the preceding 30 days or 5 times the plasma half-life, or who have previously participated in this trial