NSAID vs Steroid-NSAID Combo for Glaucoma
(CES-NSLT Trial)

Recruiting in Palo Alto (17 mi)

Overseen byEnitan A Sogbesan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: St. Joseph's Healthcare Hamilton

No Placebo Group

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Enitan A Sogbesan, MD

Principal Investigator

St. Joseph's Healthcare Hamilton

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with open-angle glaucoma.

Intraocular pressure (IOP) greater than 16 mmHg on at least two consecutive occasions separated by one month

See 2 more

Exclusion Criteria

Patients who are unable to speak/understand English

I haven't had eye disorders or surgeries in the last 6 months.

Allergy or intolerance to ketorolac or fluorometholone

See 3 more

Treatment Details

Interventions

Fluorometholone (Corticosteroid)
Ketorolac (Nonsteroidal Anti-Inflammatory Drug)

Trial OverviewThe 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.

Participant Groups

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.

Ketorolac is already approved in Switzerland for the following indications: