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Trial record 1 of 1 for:    NCT00485108
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Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty

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ClinicalTrials.gov Identifier: NCT00485108
Recruitment Status : Completed
First Posted : June 12, 2007
Last Update Posted : September 23, 2015
Sponsor:
Collaborators:
Pfizer
Glaucoma Research Society of Canada
Information provided by (Responsible Party):
Dr. Robert Campbell, Queen's University

Tracking Information
First Submitted Date  ICMJE June 9, 2007
First Posted Date  ICMJE June 12, 2007
Last Update Posted Date September 23, 2015
Study Start Date  ICMJE January 2007
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2008)
Intraocular pressure lowering effect [ Time Frame: 1 hour, 2 days, 1 month, 3 months, 6 months and 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 9, 2007)
Intra ocular pressure at one hour, two days, one month, three months, six months, and one year [ Time Frame: January 2007 to August 2008 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2008)
intraocular pressure elevation [ Time Frame: 1 hour, 2 days, 1 month ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2007)
intra ocular inflammation at one hour, two days, one month, three months, six months, and one year [ Time Frame: January 2007 to August 2008 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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, MSc Queen's University
Study Director: Delan Jinapriya, MD Queen'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