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
The disease, disorder, syndrome, illness, or injury that is being studied.
Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- primary open angle glaucoma, pseudo exfoliation glaucoma
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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 | |||||||
|---|---|---|---|---|---|---|---|
| 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 | |||||||