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

Cataract Clinical Trial

— iPERME  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03740659
• Other study ID #: LevoDesa_05-2017
• Status: Completed
• Phase: Phase 2
• Start date: September 4, 2018
• Est. completion date: December 6, 2018

Study information

• Verified date: June 2020
• Source: NTC srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 6, 2018
• Est. primary completion date: December 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Levofloxacin + Dexamethasone
Levofloxacin + Dexamethasone ophthalmic solution + dexamethasone 21-phosphate administered twice: 90(±15) min. and 60(±15) min. before limbal paracentesis.
• Levofloxacin
Levofloxacin ophthalmic solution (Oftaquix®) administered twice: 90 (±15) min. and 60 (±15) min. before limbal paracentesis).
• Dexamethasone
Dexamethasone ophthalmic solution (Tamesad®) administered twice: 90 (±15) min. and 60 (±15) min. before Limbal paracentesis.

Locations

Country	Name	City	State
Italy	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

Sponsors (1)

Lead Sponsor	Collaborator
NTC srl

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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