Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty

This study has been completed.
Sponsor:
Collaborators:
Pfizer
Glaucoma Research Society of Canada
Information provided by (Responsible Party):
Robert Campbell, Queen's University
ClinicalTrials.gov Identifier:
NCT00485108
First received: June 9, 2007
Last updated: October 17, 2011
Last verified: October 2011
  Purpose

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 Intervention
Primary Open Angle Glaucoma
Pseudo-exfoliative Glaucoma
Drug: prednisolone 1%
Drug: ketorolac 0.5%
Drug: methyl cellulose drops (artificial tears)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty (SLT): A Randomized, Masked, Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Intraocular pressure lowering effect [ Time Frame: 1 hour, 2 days, 1 month, 3 months, 6 months and 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • intraocular pressure elevation [ Time Frame: 1 hour, 2 days, 1 month ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: January 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Acular
Placebo Comparator: 3
methyl cellulose eye drop (artificial tears)
Drug: methyl cellulose drops (artificial tears)
eye drop once in each eye treated, 4 times / day for 5 days post-laser
Other Name: Refresh 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • primary open angle glaucoma, pseudo exfoliation glaucoma

Exclusion Criteria:

  • previous incisional glaucoma surgery
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00485108

Locations
Canada, Ontario
Queen's University
Kingston, Ontario, Canada
Sponsors and Collaborators
Queen's University
Pfizer
Glaucoma Research Society of Canada
Investigators
Principal Investigator: Rob J Campbell, MD, MSc Queen's University
Study Director: Delan Jinapriya, MD Queen's University
  More Information

No publications provided

Responsible Party: Robert Campbell, Assistant Professor, Queen's University
ClinicalTrials.gov Identifier: NCT00485108     History of Changes
Other Study ID Numbers: DJ1
Study First Received: June 9, 2007
Last Updated: October 17, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Queen's University:
primary open angle glaucoma
pseudo-exfoliative glaucoma
selective laser trabeculoplasty
intra ocular pressure
anti-inflammatory therapy
prednisolone acetate 1%
ketorolac tromethamine 0.5%

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Anti-Inflammatory Agents
Ketorolac
Ketorolac Tromethamine
Prednisolone hemisuccinate
Prednisolone phosphate
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Anti-Inflammatory Agents, Non-Steroidal

ClinicalTrials.gov processed this record on September 30, 2014