Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty

Sponsor

Queen's University (Other)

Overall Status

Completed

CT.gov ID

NCT00485108

Collaborator

Pfizer (Industry), Glaucoma Research Society of Canada (Other)

120

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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)	N/A

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

Study Type:

Interventional

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 :

Jan 1, 2007

Actual Primary Completion Date :

Jun 1, 2009

Actual Study Completion Date :

Dec 1, 2014

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 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

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