Pharmacokinetic Evaluation of Moxifloxacin in Vigadexa® in Aqueous Humor Samples Following Preoperative Antibiotic/Steroid Dosing in Cataract Surgery Patients

Alcon

Status and phase: Completed; Phase 4

Conditions: Cataract

Treatments: Drug: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01859702

RDG-11-235

Details and patient eligibility

About

The purpose of this study was to determine the moxifloxacin aqueous penetration when dosing with a combination drug Vigadexa preoperatively in cataract patients.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Requires cataract surgery;
• Acceptable health status (medical history, physical, laboratory and ophthalmologic exams);
• Able to follow instructions and willing to attend all study visits;
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Any known or suspected allergies/hypersensitivity to any of the investigational test product components;
• History of invasive intraocular surgery in the eye to be operated, within 4 months before enrollment;
• Use of medications, as specified in protocol;
• Severe dry eye syndrome;
• Use of contact lenses two days before surgery until the last visit;
• External eye disease, infection or inflammation of the eyes or eyelids;
• Excessive bleeding tendency;
• No vision in the eye not included in the study;
• Pregnant or breastfeeding;
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

VIGADEXA

Experimental group

Description:

Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.

Treatment:

Drug: Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution