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CompletedNCT00485108Updated Sep 23, 2015

Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty

An interventional study of prednisolone 1% and ketorolac 0.5% in Primary Open Angle Glaucoma and Pseudoexfoliation Glaucoma, sponsored by Queen's University. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-23.

Sponsored by Queen's University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Primary Open Angle Glaucoma
  • Pseudoexfoliation Glaucoma

Keywords

  • primary open angle glaucoma
  • pseudoexfoliation glaucoma
  • selective laser trabeculoplasty
  • intra ocular pressure
  • anti-inflammatory therapy
  • prednisolone acetate 1%
  • ketorolac tromethamine 0.5%
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 120 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Queen's University is the lead sponsor of 199 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • primary open angle glaucoma, pseudo exfoliation glaucoma

Exclusion criteria

Exclusion Criteria:

  • previous incisional glaucoma surgery
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    1

    Prednisolone 1% eye drop

    Drug: prednisolone 1%

  • Active comparator
    2

    ketorolac 0.5% eye drop

    Drug: ketorolac 0.5%

  • Placebo comparator
    3

    Artificial Tears (methyl cellulose eye drop)

    Drug: Artificial Tears (Methyl cellulose drops)

Interventions

  • Drugprednisolone 1%

    eye drop once in each eye treated, 4 times / day for 5 days post-laser

  • Drugketorolac 0.5%

    eye drop once in each eye treated, 4 times / day for 5 days post-laser

    Also known as: Acular

  • DrugArtificial Tears (Methyl cellulose drops)

    eye drop once in each eye treated, 4 times / day for 5 days post-laser

    Also known as: Refresh Tears

06

What researchers measure

Primary outcomes

  1. Intraocular pressure lowering effect

    Time frame: 1 hour, 2 days, 1 month, 3 months, 6 months and 1 year

Secondary outcomes

  1. intraocular pressure elevation

    Time frame: 1 hour, 2 days, 1 month

07

Study locations

1 site
  • Queen's University
    Kingston, Ontario, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00485108
Lead sponsor
Queen's University
Collaborators
Pfizer, Glaucoma Research Society of Canada
Responsible party
Dr. Robert Campbell (Assistant Professor, Queen's University) — Principal investigator
First posted
Jun 12, 2007
Start date
Jan 2007
Primary completion
Jun 2009
Completion
Dec 2014
Last update
Sep 23, 2015

Study contacts

Rob J Campbell, MD, MSc
principal investigator · Queen's University
Delan Jinapriya, MD
study director · Queen's University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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