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Nonsteroidal Anti-Inflammatory Drug

Ketorolac Alone for Open-Angle Glaucoma (CES-NSLT Trial)

Phase 4
Waitlist Available
Led By Enitan A Sogbesan, MD
Research Sponsored by St. Joseph's Healthcare Hamilton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Adults aged 18 years and older.
* Diagnosed with open-angle glaucoma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 1 year post-slt
Awards & highlights

Summary

This clinical trial, led by Dr. Enitan A. Sogbesan at the Hamilton Regional Eye Clinic, St. Joseph's Healthcare Hamilton, aims to compare the efficacy and safety of non-steroidal anti-inflammatory drug (NSAID) ketorolac alone versus a combination of ketorolac and the corticosteroid fluorometholone, and a control group receiving no postoperative treatment. The trial will evaluate these treatment strategies following Selective Laser Trabeculoplasty (SLT) in patients with open-angle glaucoma. The primary objective is to determine the most effective postoperative management strategy to reduce inflammation, improve patient comfort, and control intraocular pressure (IOP). Participants will be randomly assigned to one of the three groups, with follow-up visits scheduled at 1 hour, 1 week, 1 month, 3 months, 6 months, and 1 year post-SLT. The study's findings aim to guide clinicians in optimizing postoperative care for better patient outcomes.

Who is the study for?
This trial is for patients with open-angle glaucoma who have undergone Selective Laser Trabeculoplasty (SLT). They should not be receiving any postoperative treatment currently. The study excludes individuals who cannot follow the visit schedule or have conditions that might interfere with the drug's effects.
What is being tested?
The trial tests how effective and safe an NSAID eye drop, Ketorolac, is alone versus combined with a steroid, Fluorometholone, after SLT surgery. Patients are randomly placed in one of three groups: Ketorolac only, combination drops, or no treatment.
What are the potential side effects?
Possible side effects include eye irritation, discomfort or redness from Ketorolac; increased pressure inside the eye and cataract formation from Fluorometholone; and general risks associated with using eye drops.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 1 year post-slt
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 1 year post-slt for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Intraocular Pressure (IOP) from Baseline
Secondary study objectives
Anterior Chamber Inflammation
Incidence of Postoperative Complications
Patient-Reported Discomfort
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Ketorolac with FluorometholoneExperimental Treatment1 Intervention
Participants in this arm will receive a combination of ketorolac 0.5% eye drops administered twice daily and fluorometholone 0.1% eye drops administered four times daily for one week following Selective Laser Trabeculoplasty (SLT). Fluorometholone is a corticosteroid that reduces inflammation by stabilizing capillary permeability and inhibiting inflammatory cell activation. This arm aims to evaluate the combined efficacy and safety of ketorolac and fluorometholone in postoperative care.
Group II: Ketorolac AloneExperimental Treatment1 Intervention
Participants in this arm will receive ketorolac 0.5% eye drops administered twice daily for one week following Selective Laser Trabeculoplasty (SLT). Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that helps reduce inflammation and alleviate pain. The purpose of this intervention is to assess the efficacy and safety of ketorolac alone in managing postoperative inflammation and patient comfort compared to other treatment strategies.
Group III: No Treatment ControlActive Control1 Intervention
Participants in this arm will not receive any postoperative treatment following Selective Laser Trabeculoplasty (SLT). This control group is included to provide a baseline for comparison against the treatment groups receiving ketorolac alone or a combination of ketorolac and fluorometholone. The purpose is to assess the natural course of postoperative inflammation and patient comfort without intervention.

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Who is running the clinical trial?

St. Joseph's Healthcare HamiltonLead Sponsor
199 Previous Clinical Trials
26,549 Total Patients Enrolled
Enitan A Sogbesan, MDPrincipal InvestigatorSt. Joseph's Healthcare Hamilton
~84 spots leftby Jul 2025
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