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

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

Pfizer

Glaucoma Research Society of Canada

Information provided by (Responsible Party):

Dr. Robert Campbell, Queen's University

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.

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.

Study Design

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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 Genetics related topics: Early-onset glaucoma

MedlinePlus related topics: Tears

Drug Information available for: Ketorolac

Genetic and Rare Diseases Information Center resources: Uveal Diseases

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

intraocular pressure elevation [ Time Frame: 1 hour, 2 days, 1 month ]

Eligibility Criteria

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

Contacts and Locations

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

More Information

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Responsible Party:	Dr. Robert Campbell, Assistant Professor, Queen's University
ClinicalTrials.gov Identifier:	NCT00485108
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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Glaucoma Glaucoma, Open-Angle Exfoliation Syndrome Ocular Hypertension Eye Diseases Iris Diseases Uveal Diseases Prednisolone Ketorolac Lubricant Eye Drops Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists	Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Peripheral Nervous System Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Ophthalmic Solutions Pharmaceutical Solutions

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