Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty

Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty (SLT): A Randomized, Masked, Placebo Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma; Pseudoexfoliation Glaucoma
• Intervention / Treatment: Drug: prednisolone 1%; Drug: ketorolac 0.5%; Drug: Artificial Tears (Methyl cellulose drops)

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: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada
      • Queen's University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• primary open angle glaucoma, pseudo exfoliation glaucoma

Exclusion Criteria:

• previous incisional glaucoma surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: Refresh Tears

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intraocular pressure lowering effect	1 hour, 2 days, 1 month, 3 months, 6 months and 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
intraocular pressure elevation	1 hour, 2 days, 1 month

Collaborators and Investigators

• Sponsor: Queen's University
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: June 9, 2007
• First Submitted That Met QC Criteria: June 9, 2007
• First Posted (Estimate): June 12, 2007

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 21, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: anti-inflammatory therapy; primary open angle glaucoma; pseudoexfoliation glaucoma; selective laser trabeculoplasty; intra ocular pressure; prednisolone acetate 1%; ketorolac tromethamine 0.5%
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Uveal Diseases; Iris Diseases; Glaucoma; Glaucoma, Open-Angle; Exfoliation Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Pharmaceutical Solutions; Ophthalmic Solutions; Prednisolone; Ketorolac; Lubricant Eye Drops
• Other Study ID Numbers: DJ1