Clinical trial NCT03740659: Evaluation Of Aqueous Humor Of Levofloxacin-Dexamethasone Eye Drops And Of Its Components In Patients Undergoing Cataract Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cataract
Lead sponsor: NTC srl
Sponsor class: INDUSTRY
First posted: 2018-11-14
Enrollment: 125
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, assessor-blinded, parallel-group study.
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Aqueous Humour Concentration of Levofloxacin
timeFrame: 90±15 min after the first administration of the study treatments
measure: Aqueous Humour Concentration of Dexamethasone 21-phosphate
timeFrame: 90±15 min after the first administration of the study treatments
measure: Aqueous Humour Concentration of Dexamethasone
timeFrame: 90±15 min after the first administration of the study treatments
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: ASST Santi Paolo e Carlo di Milano - P.O. San Paolo di Milano
state: MI
city: Pisa
country: Italy
facility: A.O.U. Pisana - P.O. di Cisanello
state: PI
Study officials:
affiliation: A.O.U. Pisana - P.O. di Cisanello
name: Marco Nardi, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Figus M, Posarelli C, Romano D, Nardi M, Rossetti L. Aqueous humour concentrations after topical apPlication of combinEd levofloxacin-dexamethasone eye dRops and of its single components: a randoMised, assEssor-blinded, parallel-group study in patients undergoing cataract surgery: the iPERME study. Eur J Clin Pharmacol. 2020 Jul;76(7):929-937. doi: 10.1007/s00228-020-02863-7. Epub 2020 Apr 13.