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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

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.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Pseudoexfoliation Glaucoma Drug: prednisolone 1% Drug: ketorolac 0.5% Drug: Artificial Tears (Methyl cellulose drops) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty (SLT): A Randomized, Masked, Placebo Controlled Study
Study Start Date : January 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
Drug Information available for: Ketorolac

Arm Intervention/treatment
Active Comparator: 1
Prednisolone 1% eye drop
Drug: prednisolone 1%
eye drop once in each eye treated, 4 times / day for 5 days post-laser

Active Comparator: 2
ketorolac 0.5% eye drop
Drug: ketorolac 0.5%
eye drop once in each eye treated, 4 times / day for 5 days post-laser
Other Name: Acular

Placebo Comparator: 3
Artificial Tears (methyl cellulose eye drop)
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




Primary Outcome Measures :
  1. Intraocular pressure lowering effect [ Time Frame: 1 hour, 2 days, 1 month, 3 months, 6 months and 1 year ]

Secondary Outcome Measures :
  1. intraocular pressure elevation [ Time Frame: 1 hour, 2 days, 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • primary open angle glaucoma, pseudo exfoliation glaucoma

Exclusion Criteria:

  • previous incisional glaucoma surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00485108


Locations
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Canada, Ontario
Queen's University
Kingston, Ontario, Canada
Sponsors and Collaborators
Queen's University
Pfizer
Glaucoma Research Society of Canada
Investigators
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Principal Investigator: Rob J Campbell, MD, MSc Queen's University
Study Director: Delan Jinapriya, MD Queen's University

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Responsible Party: Dr. Robert Campbell, Assistant Professor, Queen's University
ClinicalTrials.gov Identifier: NCT00485108     History of Changes
Other Study ID Numbers: DJ1
First Posted: June 12, 2007    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by Dr. Robert Campbell, Queen's University:
primary open angle glaucoma
pseudoexfoliation glaucoma
selective laser trabeculoplasty
intra ocular pressure
anti-inflammatory therapy
prednisolone acetate 1%
ketorolac tromethamine 0.5%

Additional relevant MeSH terms:
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Exfoliation Syndrome
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Iris Diseases
Uveal Diseases
Ophthalmic Solutions
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents
Prednisolone hemisuccinate
Prednisolone phosphate
Lubricant Eye Drops
Pharmaceutical Solutions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents