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Comparing Acular LS and Pred Forte in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells - NCT00478036-80045(Clinical Trial 170828)



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City:  Aurora
State:  
CO
Zip Code: 80045
Conditions: Open Angle Glaucoma
Purpose: We will compare, in a randomized, prospective, masked and controlled fashion the effect of a nonsteroidal anti-inflammatory agent (Acular LS), a corticosteroid (Pred Forte) and a placebo (Refresh Tears) on patient discomfort, degree of intraocular pressure lowering and degree of ocular inflammation following selective laser trabeculoplasty treatment for open angle glaucoma.
Study summary: Currently, many ophthalmologists use anti-inflammatory agents like corticosteroids and nonsteroidal anti-inflammatory agents (NSAIDs) as a preventative measure to control the post-selective laser trabeculoplasty (SLT) anterior chamber inflammation. Both classes of compounds reduce inflammation through the inhibition of the cyclooxygenase pathway, whereas the corticosteroid class also inhibits the lipoxygenase pathway of the arachidonic acid cascade. Although effective, topical corticosteroids are associated with increase in intraocular pressure (IOP), posterior subcapsular cataract formation, and reduced response to infection. These adverse side effects have not been reported to occur with topical NSAIDs, which are effective in controlling the pain after SLT along with the prevention and suppression of the ocular inflammation. There are ophthalmologists who forgo using the anti-inflammatory agents post SLT and prescribe Refresh Tears to their patients to comfort the treated eye. The significance of the study lies in assessing the efficacy of Acular LS, compared to Pred Forte and to Refresh Tears in reducing discomfort, inflammation and maximizing IOP lowering following SLT procedure for open angle glaucoma with the hope of resolving the dispute over the effective post-operative care in SLT patients.
Criteria: Inclusion Criteria: - Diagnosed with open angle glaucoma patients at the Rocky Mountain Lions Eye Institute Glaucoma Clinic. - Able to provide written informed consent to participate. - Must be the age of 18 years of age or older. - Patients in which further IOP lowering by SLT is necessary in the opinion of the treating physician. Exclusion Criteria: - Patients with eye surgery in the prior six months. - Patients with prior or current use of topical or systemic corticosteroids or NSAIDs. - Patients with pre-existing anterior chamber inflammation. - Patients with known sensitivity to any of the study medications. - Due to the age range and the disease entity, special patient populations such as children or pregnant women will not be enrolled in this study
Study is available at: Rocky Mountain Lions Eye Institute
Aurora, CO 80045
United States

Primary Contact:
Mary Preston
Email: mary.preston@ucdenver.edu
Phone: 720-848-2035

Secondary Contact:
Mary Preston
Email: mary.preston@ucdenver.edu
Phone: 720-848-2035
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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