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

Phase 2

Completed

• Conditions: Cataract
• Interventions: Drug: Levofloxacin + Dexamethasone; Drug: Levofloxacin; Drug: Dexamethasone

• Registration Number: NCT03740659
• Lead Sponsor: NTC srl

Brief 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.

Detailed Description

In most cases, postoperative care after cataract surgery consists of antiinflammatory and antibacterial drug therapy. The use of an ophthalmic solution containing the combination of a steroid and an antibiotic is routinely used in clinical practice; however, treatment duration could favour the emergence of antibiotic 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 measure the concentrations of levofloxacin and dexamethasone in the aqueous humour after topical application of the combined ophthalmic solution and its single components.

Study Timeline

• Study Start: 2018-09-04
• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-13
• Study First Posted: 2018-11-14
• Primary Completion: 2018-12-06
• Study Completion: 2018-12-06
• Results First Submitted: 2020-05-13
• Status Verified: 2020-06
• Results First Submitted QC: 2020-06-19
• Last Update Submitted: 2020-06-19
• Results First Posted: 2020-07-07
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levofloxacin + Dexamethasone	Levofloxacin + Dexamethasone	Levofloxacin 5 mg/ml + Dexamethasone 1 mg/ml (30 μl administered twice before Limbal paracentesis). Limbal paracentesis will be performed prior to cataract surgery.
Levofloxacin	Levofloxacin	Levofloxacin 5 mg/ml (30 μl administered twice before Limbal paracentesis). Limbal paracentesis will be performed prior to cataract surgery.
Dexamethasone	Dexamethasone	Dexamethasone 1.14 mg/ml (26 μl administered twice before Limbal paracentesis). Limbal paracentesis will be performed prior to cataract surgery.

Primary Outcome Measures

Name	Time	Method
Aqueous Humour Concentration of Dexamethasone 21-phosphate	90±15 min after the first administration of the study treatments	Defined as the concentration of dexamethasone 21-phosphate into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin. The concentration of dexamethasone 21-phosphate has been measured by LC tandem mass spectrometry.
Aqueous Humour Concentration of Levofloxacin	90±15 min after the first administration of the study treatments	Defined as the concentration of levofloxacin into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin.The concentration of levofloxacin has been measured by LC tandem mass spectrometry.
Aqueous Humour Concentration of Dexamethasone	90±15 min after the first administration of the study treatments	Defined as the concentration of dexamethasone into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin.The concentration of dexamethasone has been measured by LC tandem mass spectrometry.

Trial Locations

Locations (2)

ASST Santi Paolo e Carlo di Milano - P.O. San Paolo di Milano; 🇮🇹 Milano, MI, Italy

A.O.U. Pisana - P.O. di Cisanello; 🇮🇹 Pisa, PI, Italy