NCT01344226

Clinical Outcomes and Evaluation of Lotemax 0.5% in Treatment of Ocular Inflammation Associated With Cataract Surgery

Clinical Outcomes and Evaluation of Lotemax (Loteprednol Ophthalmic Solution ) 0.5% QID for Treatment of Ocular Inflammation Associated With Cataract Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 49 (actual)
• Sponsor: Toyos Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Investigate the intraocular pressure(pressure inside the eye) of patients who are treated with Lotemax after undergoing cataract surgery.

Detailed description

This is a single-center study to evaluate the clinical outcomes of Lotemax 0.5% for the treatment of Ocular inflammation associated with cataract surgery. Subjects will be screened from one to 21 days prior to initiation of dosing with the test article. Subjects who sign the informed consent document and meet all inclusion/exclusion criteria will be eligible to participate in this study. Subjects will instill one drop of Lotemax into the study (operative) eye QID for a maximum of 22 days. Dosing with test article will begin the day of surgery and for 21 days after surgery. Subjects will be seen for evaluation on Days 1, 7±1, and 21 ± 2 following surgery. Subjects will be seen for a follow-up visit on Day 42 ± 3 following surgery, about 21 days after their last dose of test article. In addition to the test article regimen, subjects will receive Vigamox TID 3 days prior to surgery. Patients will receive one drop of Timoptic XE 0.5%, Zymaxid on the day of surgery. Postoperatively, patients will receive Vigamox TID for ten days and Bromday QD for 3 weeks.

Conditions

• Pseudophakia
• Inflammation

Interventions

Type	Name	Description
DRUG	loteprednol 0.5% ophthalmic solution	Lotemax to be used QID starting day of cataract surgery and 21 days after for total of 22 days.

Timeline

• Start date: 2011-04-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-04-29
• Last updated: 2018-10-22
• Results posted: 2018-10-22

Locations

1 site across 1 country: United States