NSAID vs Steroid-NSAID Combo for Glaucoma

(CES-NSLT Trial)

Overseen By Sharan Bains, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: St. Joseph's Healthcare Hamilton

Must not be taking: Systemic ketorolac, Fluorometholone

Disqualifiers: Other ocular disorders, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the best way to manage inflammation after Selective Laser Trabeculoplasty (SLT) for individuals with open-angle glaucoma. It compares the use of ketorolac (an anti-inflammatory eye drop) alone, a combination of ketorolac with another anti-inflammatory called fluorometholone, and no treatment. The goal is to determine which approach best reduces inflammation, improves comfort, and controls eye pressure. Ideal participants are those with open-angle glaucoma who have experienced higher-than-normal eye pressure on multiple occasions. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits more patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What is the safety track record for these treatments?

Research shows that ketorolac, a type of pain reliever, is generally safe for use in the eyes. Studies have found it effectively reduces pain and swelling after eye surgeries like cataract operations. Participants in these studies usually tolerated ketorolac well, with only a few side effects.

Less direct research exists on the combination of ketorolac and fluorometholone, a steroid, but both have FDA approval for other eye issues. This suggests the combination should be relatively safe, although specific studies on this mix remain limited.

Overall, both treatments in this trial are expected to be well-tolerated. Participants should still be aware of possible side effects, such as mild eye irritation or discomfort, and report any concerns to their doctors. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for glaucoma because they explore new ways to manage postoperative inflammation after Selective Laser Trabeculoplasty (SLT). Unlike standard treatments that often rely heavily on corticosteroids, one arm of this study uses ketorolac alone, a non-steroidal anti-inflammatory drug (NSAID), which may reduce inflammation without the side effects associated with steroids. Another arm combines ketorolac with fluorometholone, a corticosteroid, to potentially enhance anti-inflammatory effects while minimizing steroid exposure. This approach could offer patients improved comfort and healing with fewer side effects.

What evidence suggests that this trial's treatments could be effective for glaucoma?

In this trial, participants will join different treatment arms to evaluate postoperative care following Selective Laser Trabeculoplasty (SLT) for glaucoma. Research has shown that ketorolac, a non-steroidal anti-inflammatory drug (NSAID), effectively reduces swelling and pain after eye surgeries, such as cataract surgery. For instance, studies found it significantly decreases signs of inflammation, including certain cells and proteins in the eye. Participants in one arm of this trial will receive ketorolac alone. Another arm will test the combination of ketorolac with the corticosteroid fluorometholone, which research indicates reduces inflammation by calming the body's response. Combining these two drugs may effectively manage swelling and pain after eye procedures. Overall, both treatment methods show promise in improving recovery and comfort for patients with glaucoma after surgery. ^{1 6 7 8 9}

Who Is on the Research Team?

Enitan A Sogbesan, MD

Principal Investigator

St. Joseph's Healthcare Hamilton

Are You a Good Fit for This Trial?

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 have been diagnosed with open-angle glaucoma.

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

Provided informed consent

Exclusion Criteria

Patients who are unable to speak/understand English

I have used ketorolac or fluorometholone in the last month.

Pregnancy or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ketorolac alone, a combination of ketorolac and fluorometholone, or no treatment following Selective Laser Trabeculoplasty (SLT)

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in intraocular pressure, visual acuity, anterior chamber inflammation, and patient-reported discomfort

1 year

6 visits (in-person) at 1 hour, 1 week, 1 month, 3 months, 6 months, and 1 year post-SLT

What Are the Treatments Tested in This Trial?

Interventions

• Fluorometholone
• Ketorolac

Trial Overview 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.

How Is the Trial Designed?

Group I: Ketorolac with Fluorometholone Experimental Treatment 1 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 Alone Experimental Treatment 1 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 Control Active Control 1 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 United States, European Union, Switzerland for the following indications:

Approved in United States as Toradol for:

• Moderate to severe pain
• Postoperative pain
• Dysmenorrhea
• Idiopathic pericarditis
• Ocular itching

Approved in European Union as Toradol for:

• Moderate to severe pain
• Postoperative pain
• Dysmenorrhea

Approved in United States as Acular for:

• Ocular itching
• Inflammation after eye surgery

Approved in United States as Sprix for:

• Moderate to severe pain

Approved in Switzerland as Ketorolac for:

• Moderate to severe pain
• Postoperative pain

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials

203

Recruited

26,900+

Published Research Related to This Trial

In a retrospective study of breast surgery patients over three years, ketorolac did not significantly increase the risk of postoperative hematoma formation, with rates of 3.5% in those receiving ketorolac compared to 2.5% in those who did not.

The overall hematoma rate for the entire cohort was 2.8%, suggesting that ketorolac can be safely used for postoperative pain control without raising concerns about bleeding complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toradol following Breast Surgery: Is There an Increased Risk of Hematoma? Nguyen, BN., Barta, RJ., Stewart, CE., et al.[2021]

In a study involving 15 rabbits, intraocular injections of preservative-free ketorolac tromethamine showed no significant adverse effects on retinal function or intraocular pressure compared to control eyes, indicating its safety for use.

The drug had a short elimination half-life of 2.3 hours in the vitreous, and no histopathological changes were observed, suggesting that ketorolac could be a viable alternative to steroid injections for treating intraocular conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of intraocular ketorolac in rabbits. Margalit, E., Kugler, LJ., Brumm, MV., et al.[2022]

In a multicenter study involving patients with moderate to severe inflammation after cataract surgery, ketorolac tromethamine 0.5% was significantly more effective than a placebo in reducing inflammation and associated symptoms like pain and photophobia.

The treatment was found to be safe, with no significant differences in visual acuity or adverse events compared to the placebo, indicating that ketorolac is a reliable option for managing post-surgical inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketorolac tromethamine 0.5% ophthalmic solution in the treatment of moderate to severe ocular inflammation after cataract surgery: a randomized, vehicle-controlled clinical trial. Heier, J., Cheetham, JK., Degryse, R., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3130912/

Critical appraisal of ophthalmic ketorolac in treatment ... A large randomized, multicenter, placebo-controlled study demonstrated significantly less inflammation and pain after cataract surgery using Acuvail.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002939498004139

Ketorolac tromethamine 0.5% ophthalmic solution in the ... Ketorolac was significantly more effective than the vehicle solution in reducing anterior chamber cells (P ≤ .030) and flare (P ≤ .025), conjunctival erythema ( ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/iwj.14661

A meta‐analysis of topical Ketorolac's effect on surgical site ... This meta-analysis supports the role of topical ketorolac in enhancing wound healing and reducing scar formation after cataract surgery.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11620299/

Comparing the sedative and analgesic effects of ketorolac ... This study suggests that ketorolac eye drops are more effective than diclofenac eye drops in significantly reducing intraoperative pain among ...

5. eyeworld.org eyeworld.org/2021/effect-of-anti-inflammatory-regimen-on-early-postoperative-inflammation/

Review of “Effect of anti-inflammatory regimen on early ... Efficient and effective postoperative control of inflammation helps ensure the high-quality, successful outcomes expected by both physicians and patients.

6. detroitanesthesiaservices.com detroitanesthesiaservices.com/topical-ketorolac-for-postoperative-ocular-pain/

Topical Ketorolac for Postoperative Ocular Pain Studies have found ketorolac tromethamine to be effective in reducing pain and inflammation across a range of pre-, intra-, and postoperative contexts.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/019700s033lbl.pdf

ACULAR® (ketorolac tromethamine ophthalmic solution) 0.5 ... Temporary Relief of Ocular Itching Due to Seasonal Allergic Conjunctivitis. The recommended dosage of ACULAR is one drop four times a day to the affected eye(s) ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27440142/

Safety Considerations in the Use of Ketorolac for ... Perioperative administration of ketorolac has been demonstrated to be safe and effective in healthy patients and is particularly beneficial as an ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S014929180088323X

Efficacy and safety profile of ketorolac 0.5% ophthalmic ... This multicenter, double-masked, randomized, parallel study compared the efficacy and safety profile of ketorolac tromethamine 0.5% ophthalmic solution with ...