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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fluoroquinolones; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ophthalmic Solutions; Tetrahydrozoline

Criteria

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