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

NCT ID: NCT03740659

Last Updated: 2020-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-04
• Study Completion Date: 2018-12-06

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.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Levofloxacin + Dexamethasone

Intervention Type: DRUG

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

Levofloxacin

Levofloxacin 5 mg/ml (30 μl administered twice before Limbal paracentesis).

Limbal paracentesis will be performed prior to cataract surgery.

Group Type: ACTIVE_COMPARATOR

Levofloxacin

Intervention Type: DRUG

Levofloxacin ophthalmic solution (Oftaquix®) administered twice: 90 (±15) min. and 60 (±15) min. before limbal paracentesis).

Dexamethasone

Dexamethasone 1.14 mg/ml (26 μl administered twice before Limbal paracentesis).

Limbal paracentesis will be performed prior to cataract surgery.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Dexamethasone ophthalmic solution (Tamesad®) administered twice: 90 (±15) min. and 60 (±15) min. before Limbal paracentesis.

Interventions

Levofloxacin + Dexamethasone

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

Intervention Type: DRUG

Levofloxacin

Levofloxacin ophthalmic solution (Oftaquix®) administered twice: 90 (±15) min. and 60 (±15) min. before limbal paracentesis).

Intervention Type: DRUG

Dexamethasone

Dexamethasone ophthalmic solution (Tamesad®) administered twice: 90 (±15) min. and 60 (±15) min. before Limbal paracentesis.

Intervention Type: DRUG

Other Intervention Names

Oftaquix®; Tamesad®

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NTC srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marco Nardi, Prof.

Role: PRINCIPAL_INVESTIGATOR

A.O.U. Pisana - P.O. di Cisanello

Locations

ASST Santi Paolo e Carlo di Milano - P.O. San Paolo di Milano

Milan, MI, Italy

A.O.U. Pisana - P.O. di Cisanello

Pisa, PI, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 32285142 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

LevoDesa_05-2017

Identifier Type: -

Identifier Source: org_study_id