Anti-inflammatory Therapy Following Selective Laser Trabe... | NCT00485108

Studies
Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty

NCT00485108

Sponsor

Queen's University

Status

Completed

Last Update Posted

Sep 23, 2015Estimated

Enrollment

120Actual

Phase

Not Applicable

Conditions

Primary Open Angle Glaucoma
Pseudoexfoliation Glaucoma

Interventions

prednisolone 1%
ketorolac 0.5%
Artificial Tears (Methyl cellulose drops)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Jun 2009Actual

Completion Date

Dec 2014Actual

First Submitted Date

Jun 9, 2007

First Submission Date that Met QC Criteria

Jun 9, 2007

First Posted Date

Jun 12, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2015

Last Update Posted Date

Sep 23, 2015Estimated

Name	Class
Pfizer	INDUSTRY
Glaucoma Research Society of Canada	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
prednisolone 1%	Drug	eye drop once in each eye treated, 4 times / day for 5 days post-laser	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

primary open angle glaucoma, pseudo exfoliation glaucoma

Exclusion Criteria:

previous incisional glaucoma surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rob J Campbell, MD, MSc	Queen's University	Principal Investigator
Delan Jinapriya, MD	Queen's University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen's University		Kingston	Ontario		Canada

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle
D017889	Exfoliation Syndrome

Ancestor Terms

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension
D005128	Eye Diseases
D007499	Iris Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C025494	1(beta)-D-arabinofuranosylcytosine-5'-diphosphate prednisolone
D020911	Ketorolac Tromethamine
D065346	Lubricant Eye Drops

Ancestor Terms

ID	Term
D007213	Indomethacin
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided