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Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00485108
First Posted: June 12, 2007
Last Update Posted: September 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Pfizer
Glaucoma Research Society of Canada
Information provided by (Responsible Party):
Dr. Robert Campbell, Queen's University
  Purpose
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 Intervention
Primary Open Angle Glaucoma Pseudoexfoliation Glaucoma Drug: prednisolone 1% Drug: ketorolac 0.5% Drug: Artificial Tears (Methyl cellulose drops)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dr. Robert Campbell, Queen's University:

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 ]

Enrollment: 120
Study Start Date: January 2007
Study Completion Date: December 2014
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Canada, Ontario
Queen's University
Kingston, Ontario, Canada
Sponsors and Collaborators
Queen's University
Pfizer
Glaucoma Research Society of Canada
Investigators
Principal Investigator: Rob J Campbell, MD, MSc Queen's University
Study Director: Delan Jinapriya, MD Queen's University
  More Information

Responsible Party: Dr. Robert Campbell, Assistant Professor, Queen's University
ClinicalTrials.gov Identifier: NCT00485108     History of Changes
Other Study ID Numbers: DJ1
First Submitted: June 9, 2007
First Posted: June 12, 2007
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:
Glaucoma
Glaucoma, Open-Angle
Exfoliation Syndrome
Ocular Hypertension
Eye Diseases
Iris Diseases
Uveal Diseases
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents
Prednisolone hemisuccinate
Prednisolone phosphate
Tetrahydrozoline
Ophthalmic Solutions
Lubricant Eye Drops
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