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Nonsteroidal Anti-Inflammatory Drug

NSAID vs Steroid-NSAID Combo for 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

Diagnosed with open-angle glaucoma

Visual acuity of 20/200 or better in at least one eye

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 1 year post-slt

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial aims to compare the effectiveness and safety of using a non-steroidal anti-inflammatory drug (ketorolac) alone, ketorolac combined with a corticosteroid (flu

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

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I have been diagnosed with open-angle glaucoma.

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I can see well enough with at least one eye.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 1 year post-slt

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 2Eligibility criteria met