Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty
NCT00485108
Last updated date
ABOUT THIS STUDY
The type of anti-inflammatory medication used post selective laser trabeculoplasty (SLT) may
have an impact on the intra-ocular pressure (IOP) lowering effect of SLT. This study will
evaluate the IOP lowering effect of SLT following the topical administration of one of the
following: prednisolone 1%, ketorolac 0.5% or artificial tears.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma
Sex
Females and Males
Age
18 + years
Inclusion Criteria
Show details
- primary open angle glaucoma, pseudo exfoliation glaucoma
Exclusion Criteria
Show details
- previous incisional glaucoma surgery
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Primary Open Angle Glaucoma, Pseudoexfoliation GlaucomaAnti-inflammatory Therapy Following Selective Laser Trabeculoplasty
NCT00485108
- Kingston, Ontario
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | |||||||
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Brief Title ICMJE | Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty | ||||||
Official Title ICMJE | Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty (SLT): A Randomized, Masked, Placebo Controlled Study | ||||||
Brief Summary | The type of anti-inflammatory medication used post selective laser trabeculoplasty (SLT) may have an impact on the intra-ocular pressure (IOP) lowering effect of SLT. This study will evaluate the IOP lowering effect of SLT following the topical administration of one of the following: prednisolone 1%, ketorolac 0.5% or artificial tears. | ||||||
Detailed Description | Patients who have been chosen to undergo SLT for glaucoma will be randomized to receive one of prednisolone 1%, ketorolac 0.5% or artificial tears four times a day for 5 days following administration of the laser treatment. The IOP will be measured at various time points following SLT: 1 hour, 2 days, 1 week, 1 month, 3 months, 6 months, and 1 year. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 120 | ||||||
Original Estimated Enrollment ICMJE | 360 | ||||||
Actual Study Completion Date ICMJE | December 2014 | ||||||
Actual Primary Completion Date | June 2009 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Canada | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00485108 | ||||||
Other Study ID Numbers ICMJE | DJ1 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Dr. Robert Campbell, Queen's University | ||||||
Study Sponsor ICMJE | Queen's University | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Queen's University | ||||||
Verification Date | September 2015 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |