Evaluation of aqueous humor concentrations after local application of combined levofloxacin-dexamethasone eye drops and of its single components: randomized, parallel group, with blinded evaluator in patients undergoing cataract surgery

Phase 1

• Conditions: Patients for which cataract surgery has been planned.; MedDRA version: 20.0Level: PTClassification code 10007739Term: CataractSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2018-001149-15-IT
• Lead Sponsor: TC SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-13
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed
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 (Oxford scheme grade 0)
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

1. Corneal epithelium integrity not confirmed by fluorescein test
2. History of corneal disease or dystrophy (e.g. ocular herpes, conjunctivitis, keratitis)
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 (oxybuprocaine hydrochloride - Novesina®) followed by povidone-iodine (Oftasteril®) within 10 minutes before start of surgery
9. Treatment with any topical steroid or antibiotic drug in the 7 days prior to cataract surgery (artificial tears without BAK are allowed)
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, whichever is longer, or who have previously participated in this trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified