NCT00485108

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

2.4 years

First QC Date

June 9, 2007

Last Update Submit

September 21, 2015

Conditions

Primary Open Angle GlaucomaPseudoexfoliation Glaucoma

Keywords

primary open angle glaucomapseudoexfoliation glaucomaselective laser trabeculoplastyintra ocular pressureanti-inflammatory therapyprednisolone acetate 1%ketorolac tromethamine 0.5%

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure lowering effect

    1 hour, 2 days, 1 month, 3 months, 6 months and 1 year

Secondary Outcomes (1)

  • intraocular pressure elevation

    1 hour, 2 days, 1 month

Study Arms (3)

1

ACTIVE COMPARATOR

Prednisolone 1% eye drop

Drug: prednisolone 1%

2

ACTIVE COMPARATOR

ketorolac 0.5% eye drop

Drug: ketorolac 0.5%

3

PLACEBO COMPARATOR

Artificial Tears (methyl cellulose eye drop)

Drug: Artificial Tears (Methyl cellulose drops)

Interventions

prednisolone 1%DRUG

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

1
ketorolac 0.5%DRUG

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

Also known as: Acular
2
Artificial Tears (Methyl cellulose drops)DRUG

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

Also known as: Refresh Tears
3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary open angle glaucoma, pseudo exfoliation glaucoma

You may not qualify if:

  • previous incisional glaucoma surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen's University

Kingston, Ontario, Canada

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleExfoliation Syndrome

Interventions

1(beta)-D-arabinofuranosylcytosine-5'-diphosphate prednisoloneKetorolac TromethamineLubricant Eye Drops

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesIris DiseasesUveal Diseases

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsOphthalmic SolutionsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesLubricantsSpecialty Uses of Chemicals

Study Officials

  • Rob J Campbell, MD, MSc

    Queen's University

    PRINCIPAL INVESTIGATOR

  • Delan Jinapriya, MD

    Queen's University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 9, 2007

First Posted

June 12, 2007

Study Start

January 1, 2007

Primary Completion

June 1, 2009

Study Completion

December 1, 2014

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

CA(1)