Clinical Outcomes and Evaluation of Lotemax 0.5% in Treatment of Ocular Inflammation Associated With Cataract Surgery
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|ClinicalTrials.gov Identifier: NCT01344226|
Recruitment Status : Completed
First Posted : April 29, 2011
Results First Posted : October 22, 2018
Last Update Posted : October 22, 2018
|Condition or disease||Intervention/treatment|
|Pseudophakia Inflammation||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.
|Study Type :||Observational|
|Actual Enrollment :||49 participants|
|Official Title:||Clinical Outcomes and Evaluation of Lotemax (Loteprednol Ophthalmic Solution ) 0.5% QID for Treatment of Ocular Inflammation Associated With Cataract Surgery|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
- 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.Other Names:
- 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 intraocular pressure change in mm Hg from baseline in the first 6 weeks following cataract surgery in individuals treated with Lotemax (loteprednol ophthalmic solution) 0.5% QID after cataract extraction with posterior chamber intraocular implantation.
- ETDRS Letters Read Over Early Postoperative Period [ Time Frame: change in ETDRS letters read baseline to 6 weeks ]Final visual acuity at pod 42 as measured by ETDRS letters read was compared with baseline was measured for this outcome measure.
- Cell Scores in the Early Outcome Period as Measured at 6 Weeks Post Phacoemulsification [ Time Frame: baseline to 6 weeks ]Cell scores at the final visit (pod 42) will be compared with baseline cells and will be measured using 1mmx1mm slit lamp beam. White cells present in the anterior chamber in a 1mm x 1mm slit lamp beam measured 3 times with the average number of cells being recorded. The grading scale was 0 (no cells/high power field), 1 (1-5 cells/high power field), 2 (6-15 cells/high power field), 3 (16-25 cells/high power field) and 4 (>25 cells/high power field). Minimal values represent less inflammation or better inflammatory control and could represent a better outcome.
- Flare Scores in Early Postoperative Period [ Time Frame: baseline to 6 weeks ]Flare scores will be measured using a 1mmx1mm slit lamp beam. Flare was assessed by looking at a 1mmx1mm slit lamp beam into the anterior chamber. Three measurements were taken and the average flare score was reported. The final outcome measure was the final flare score at 42 days compared to baseline. The grading scale was 0-4 with 0 repesenting no flare, 1mild flare, 2 moderate flare, 3 moderate severe and 4 severe flare. Minmal values represent less inflammation and could represent better inflammatory control.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344226
|United States, Missouri|
|Discover Vision Centers|
|Independence, Missouri, United States, 64055|
|Principal Investigator:||Melissa Toyos, MD||Discover Vision Centers|