Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty

NCT00485108

Last updated date
Study Location
Queen's University
Kingston, Ontario, , Canada
Contact
1-800-718-1021

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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
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
  1. 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
  • Primary Open Angle Glaucoma
  • Pseudoexfoliation Glaucoma
Intervention  ICMJE
  • Drug: prednisolone 1%
    eye drop once in each eye treated, 4 times / day for 5 days post-laser
  • Drug: ketorolac 0.5%
    eye drop once in each eye treated, 4 times / day for 5 days post-laser
    Other Name: Acular
  • Drug: Artificial Tears (Methyl cellulose drops)
    eye drop once in each eye treated, 4 times / day for 5 days post-laser
    Other Name: Refresh Tears
Study Arms  ICMJE
  • Active Comparator: 1
    Prednisolone 1% eye drop
    Intervention: Drug: prednisolone 1%
  • Active Comparator: 2
    ketorolac 0.5% eye drop
    Intervention: Drug: ketorolac 0.5%
  • Placebo Comparator: 3
    Artificial Tears (methyl cellulose eye drop)
    Intervention: Drug: Artificial Tears (Methyl cellulose drops)
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
 (submitted: May 20, 2008)
120
Original Estimated Enrollment  ICMJE
 (submitted: June 9, 2007)
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:

  • primary open angle glaucoma, pseudo exfoliation glaucoma

Exclusion Criteria:

  • previous incisional glaucoma surgery
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
  • Pfizer
  • Glaucoma Research Society of Canada
Investigators  ICMJE
Principal Investigator:Rob J Campbell, MD, MScQueen's University
Study Director:Delan Jinapriya, MDQueen's University
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