Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty

NCT ID: NCT00485108

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Primary Open Angle Glaucoma Pseudoexfoliation Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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1

Prednisolone 1% eye drop

Group Type ACTIVE_COMPARATOR

prednisolone 1%

Intervention Type DRUG

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

2

ketorolac 0.5% eye drop

Group Type ACTIVE_COMPARATOR

ketorolac 0.5%

Intervention Type DRUG

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

3

Artificial Tears (methyl cellulose eye drop)

Group Type PLACEBO_COMPARATOR

Artificial Tears (Methyl cellulose drops)

Intervention Type DRUG

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

Interventions

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prednisolone 1%

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

Intervention Type DRUG

ketorolac 0.5%

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

Intervention Type DRUG

Artificial Tears (Methyl cellulose drops)

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

Intervention Type DRUG

Other Intervention Names

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Acular Refresh Tears

Eligibility Criteria

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Inclusion Criteria

* primary open angle glaucoma, pseudo exfoliation glaucoma

Exclusion Criteria

* previous incisional glaucoma surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Glaucoma Research Society of Canada

OTHER

Sponsor Role collaborator

Queen's University

OTHER

Sponsor Role lead

Responsible Party

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Dr. Robert Campbell

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rob J Campbell, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Delan Jinapriya, MD

Role: STUDY_DIRECTOR

Queen's University

Locations

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Queen's University

Kingston, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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DJ1

Identifier Type: -

Identifier Source: org_study_id

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