Back to resultsAnti-inflammatory Therapy Following Selective Laser Trabeculoplasty
Primary Purpose
Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
prednisolone 1%
ketorolac 0.5%
Artificial Tears (Methyl cellulose drops)
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring primary open angle glaucoma, pseudoexfoliation glaucoma, selective laser trabeculoplasty, intra ocular pressure, anti-inflammatory therapy, prednisolone acetate 1%, ketorolac tromethamine 0.5%
Eligibility Criteria
Inclusion Criteria:
- primary open angle glaucoma, pseudo exfoliation glaucoma
Exclusion Criteria:
- previous incisional glaucoma surgery
Sites / Locations
- Queen's University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1
2
3
Arm Description
Prednisolone 1% eye drop
ketorolac 0.5% eye drop
Artificial Tears (methyl cellulose eye drop)
Outcomes
Primary Outcome Measures
Intraocular pressure lowering effect
Secondary Outcome Measures
intraocular pressure elevation
Full Information
NCT ID
NCT00485108
First Posted
June 9, 2007
Last Updated
September 21, 2015
Sponsor
Queen's University
Collaborators
Pfizer, Glaucoma Research Society of Canada
1. Study Identification
Unique Protocol Identification Number
NCT00485108
Brief Title
Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty
Official Title
Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty (SLT): A Randomized, Masked, Placebo Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
Pfizer, Glaucoma Research Society of Canada
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma
Keywords
primary open angle glaucoma, pseudoexfoliation glaucoma, selective laser trabeculoplasty, intra ocular pressure, anti-inflammatory therapy, prednisolone acetate 1%, ketorolac tromethamine 0.5%
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Prednisolone 1% eye drop
Arm Title
2
Arm Type
Active Comparator
Arm Description
ketorolac 0.5% eye drop
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Artificial Tears (methyl cellulose eye drop)
Intervention Type
Drug
Intervention Name(s)
prednisolone 1%
Intervention Description
eye drop once in each eye treated, 4 times / day for 5 days post-laser
Intervention Type
Drug
Intervention Name(s)
ketorolac 0.5%
Other Intervention Name(s)
Acular
Intervention Description
eye drop once in each eye treated, 4 times / day for 5 days post-laser
Intervention Type
Drug
Intervention Name(s)
Artificial Tears (Methyl cellulose drops)
Other Intervention Name(s)
Refresh Tears
Intervention Description
eye drop once in each eye treated, 4 times / day for 5 days post-laser
Primary Outcome Measure Information:
Title
Intraocular pressure lowering effect
Time Frame
1 hour, 2 days, 1 month, 3 months, 6 months and 1 year
Secondary Outcome Measure Information:
Title
intraocular pressure elevation
Time Frame
1 hour, 2 days, 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
primary open angle glaucoma, pseudo exfoliation glaucoma
Exclusion Criteria:
previous incisional glaucoma surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rob J Campbell, MD, MSc
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Delan Jinapriya, MD
Organizational Affiliation
Queen's University
Official's Role
Study Director
Facility Information:
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty
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