Comparing Acular LS and Pred Forte in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells
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| First Received Date ICMJE | May 23, 2007 | ||||||||
| Last Updated Date | January 29, 2013 | ||||||||
| Start Date ICMJE | May 2007 | ||||||||
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Patient Discomfort, Degree of Intraocular Pressure Lowering, and Degree of Ocular Inflammation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00478036 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Comparing Acular LS and Pred Forte in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells | ||||||||
| Official Title ICMJE | A Randomized Prospective Double Masked Controlled Trial Comparing Ketorolac Tromethamine 0.4% and Prednisolone Acetate 1% in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells. | ||||||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Open Angle Glaucoma | ||||||||
| Intervention ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 90 | ||||||||
| Estimated Completion Date | February 2014 | ||||||||
| Estimated Primary Completion Date | February 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00478036 | ||||||||
| Other Study ID Numbers ICMJE | 06-1251 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | University of Colorado, Denver | ||||||||
| Study Sponsor ICMJE | University of Colorado, Denver | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Colorado, Denver | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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