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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Aqueous Humour Concentrations After Topical apPlication of combinEd Levofloxacin-dexamethasone Eye dRops and of Its Single Components: a randoMized, assEssor-blinded, Parallel-group Study in Patients Undergoing Cataract Surgery - iPERME

Conditions
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Cataract

Intervention / Treatment
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* Drug: Levofloxacin + Dexamethasone
* Drug: Levofloxacin
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent Male or female patients, aged ≥40 years Patient undergoing phacoemulsification Corneal thickness between 450 μm and 600 μm as measured by means of pachymetry Corneal integrity confirmed by means of fluorescein test Adequate pupil dilation assessed at screening Female patients of childbearing potential must have a negative pregnancy test Ability to fully understand all study procedures Exclusion Criteria: Corneal epithelium integrity not confirmed by fluorescein test History of corneal disease or dystrophy History of ocular trauma with corneal damage History of acute ocular inflammation (including uveitis) in the 6 months prior to screening Previous ocular surgery (including laser treatment) Glaucoma Treatment with an ophthalmic investigational drug in the 3 months prior to screening 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 Treatment with any topical steroid or antibiotic drug in the 7 days prior to cataract surgery Treatment with any systemic steroid or antibiotic drug in the 7 days prior to cataract surgery Known hypersensitivity to levofloxacin, other fluoroquinolones or dexamethasone Pregnant or lactating women 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized, assessor-blinded, parallel-group study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Levofloxacin + Dexamethasone<br>Levofloxacin 5 mg/ml + Dexamethasone 1 mg/ml (30 μl administered twice before Limbal paracentesis). Limbal paracentesis will be performed prior to cataract surgery. | Drug: Levofloxacin + Dexamethasone<br>* Levofloxacin + Dexamethasone ophthalmic solution + dexamethasone 21-phosphate administered twice: 90(±15) min. and 60(±15) min. before limbal paracentesis.<br>|
| Active Comparator: Levofloxacin<br>Levofloxacin 5 mg/ml (30 μl administered twice before Limbal paracentesis). Limbal paracentesis will be performed prior to cataract surgery. | Drug: Levofloxacin<br>* Levofloxacin ophthalmic solution (Oftaquix®) administered twice: 90 (±15) min. and 60 (±15) min. before limbal paracentesis).<br>* Other names: Oftaquix®;|
| Active Comparator: Dexamethasone<br>Dexamethasone 1.14 mg/ml (26 μl administered twice before Limbal paracentesis). Limbal paracentesis will be performed prior to cataract surgery. | Drug: Dexamethasone<br>* Dexamethasone ophthalmic solution (Tamesad®) administered twice: 90 (±15) min. and 60 (±15) min. before Limbal paracentesis.<br>* Other names: Tamesad®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aqueous Humour Concentration of Levofloxacin | 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. | 90±15 min after the first administration of the study treatments | 
| Aqueous Humour Concentration of Dexamethasone 21-phosphate | 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. | 90±15 min after the first administration of the study treatments | 
| Aqueous Humour Concentration of Dexamethasone | 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. | 90±15 min after the first administration of the study treatments |