Study of Efficacy and Safety of Vigadexa in Treating Inflammation and Infection Post-cataract Surgery

Alcon

Status and phase: Completed; Phase 4

Conditions: Cataract

Treatments: Drug: Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT00870103

RM-08-05

Details and patient eligibility

About

To demonstrate that the combination formulation of Moxifloxacin/Dexamethasone Eye Drop is effective and safe for the prevention of postoperative inflammation as a consequence of cataract extraction surgery.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≧18 years of age
• able to sign an informed consent and complete all required visits
• intends to have a cataract extraction surgery followed by implantation of a posterior chamber Intraocular lens (IOL)
• Intraocular Pressure (IOP) ≦ 20 millimeters mercury (mmHg)

Exclusion criteria

• Uncontrolled glaucoma or IOP
• use of ocular anti-infectious during the study and within 30 days prior to the enrollment, secondary implantation or replacement of IOL in the study eye
• use of steroid during the study or within 14 days prior to enrollment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Vigadexa eye drops

Experimental group

Description:

Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops

Treatment:

Drug: Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops