Clinical Outcomes and Evaluation of Lotemax 0.5% in Treatment of Ocular Inflammation Associated With Cataract Surgery
Recruitment status was: Active, not recruiting
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Clinical Outcomes and Evaluation of Lotemax (Loteprednol Ophthalmic Solution ) 0.5% QID for Treatment of Ocular Inflammation Associated With Cataract Surgery|
- Investigate clinical outcomes for intraocular pressure after treatment with Lotemax (loteprednol ophthalmic solution) 0.5% QID in subjects who have undergone cataract extraction with posterior chamber intraocular implantation. [ Time Frame: baseline to 6 weeks ]Evaluate the Safety of treatment with Lotemax (loteprednol ophthalmic solution) 0.5% QID in subjects who have undergone cataract extraction with posterior chamber intraocular implantation.
- ETDRS letters read over early postoperative period [ Time Frame: baseline to 6 weeks ]ETDRS letters read will be assessed at baseline and at pod1, pod7, pod21 and pod42. Acuities will be
- cell scores in early postoperative period [ Time Frame: baseline to 6 weeks ]Cell scores will be measured using 1mmx1mm slit lamp beam at baseline, pod1, pod7,pod21 and pod42.
- Flare scores in early postoperative period [ Time Frame: baseline to 6 weeks ]Flare scores will be measured using a 1mmx1mm slit lamp beam at baseline, pod1, pod7, and pod42
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Drug: loteprednol 0.5% ophthalmic solution
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344226
|United States, Missouri|
|Discover Vision Centers|
|Independence, Missouri, United States, 64055|
|Principal Investigator:||Melissa Cable, MD||Discover Vision Centers|