Anti-Inflammatory Therapy Following Selective Laser Trabeculoplasty - Full Text View

Sponsors and Collaborators:	Queen's University Pfizer Glaucoma Research Society of Canada
Information provided by:	Queen's University
ClinicalTrials.gov Identifier:	NCT00485108

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 Pseudo-Exfoliative Glaucoma	Drug: prednisolone 1% Drug: ketorolac 0.5% Drug: methyl cellulose drops (artificial tears)

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Prednisolone Prednisolone acetate Depo-medrol Cellulose sodium phosphate Ketorolac Ketorolac tromethamine Medrol veriderm Methylprednisolone Prednisolone sodium phosphate Prednisolone Sodium Succinate Methylprednisolone Sodium Succinate Methylprednisolone hemisuccinate 6-Methylprednisolone Cellulose Methylcellulose Phosphocellulose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Anti-Inflammatory Therapy Following Selective Laser Trabeculoplasty (SLT): A Randomized, Masked, Placebo Controlled Study

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

intraocular pressure elevation [ Time Frame: 1 hour, 2 days, 1 month ] [ Designated as safety issue: Yes ]

Enrollment:	120
Study Start Date:	January 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Prednisolone 1% eye drop	Drug: prednisolone 1% eye drop once in each eye treated, 4 times / day for 5 days post-laser
2: Active Comparator ketorolac 0.5% eye drop	Drug: ketorolac 0.5% eye drop once in each eye treated, 4 times / day for 5 days post-laser
3: Placebo Comparator methyl cellulose eye drop (artificial tears)	Drug: methyl cellulose drops (artificial tears) eye drop once in each eye treated, 4 times / day for 5 days post-laser

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

primary open angle glaucoma, pseudo exfoliation glaucoma

Exclusion Criteria:

previous incisional glaucoma surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	Queen's University ( Dr. Rob Campbell )
Study ID Numbers:	DJ1
Study First Received:	June 9, 2007
Last Updated:	January 14, 2009
ClinicalTrials.gov Identifier:	NCT00485108 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Queen's University:

primary open angle glaucoma
pseudo-exfoliative glaucoma
selective laser trabeculoplasty
intra ocular pressure

anti-inflammatory therapy
prednisolone acetate 1%
ketorolac tromethamine 0.5%

Study placed in the following topic categories:

Anti-Inflammatory Agents
Methylprednisolone
Hormone Antagonists
Ketorolac
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Tetrahydrozoline
Hormones
Neuroprotective Agents
Glaucoma
Glaucoma, Open-Angle
Anti-Inflammatory Agents, Non-Steroidal
Analgesics

Methylprednisolone Hemisuccinate
Antineoplastic Agents, Hormonal
Eye Diseases
Cyclooxygenase Inhibitors
Methylprednisolone acetate
Glucocorticoids
Analgesics, Non-Narcotic
Prednisolone
Peripheral Nervous System Agents
Antirheumatic Agents
Ketorolac Tromethamine
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Methylprednisolone
Antineoplastic Agents
Ketorolac
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Hormones
Neuroprotective Agents
Sensory System Agents
Glaucoma
Therapeutic Uses
Glaucoma, Open-Angle

Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Methylprednisolone Hemisuccinate
Antineoplastic Agents, Hormonal
Eye Diseases
Cyclooxygenase Inhibitors
Gastrointestinal Agents
Methylprednisolone acetate
Enzyme Inhibitors
Protective Agents
Glucocorticoids
Pharmacologic Actions
Analgesics, Non-Narcotic
Autonomic Agents
Prednisolone

ClinicalTrials.gov processed this record on May 07, 2009