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Open Angle GlaucomaPhase 4CES-NSLTNCT06498440

Efficacy of NSAID vs. Steroid-NSAID Combo Post-Selective Laser Trabeculoplasty: Phase 4, Single-Center RCT

A Phase 4 study testing Ketorolac 0.5% Eye Drops and Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops in people with Open Angle Glaucoma and Ocular Hypertension, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ketorolac 0.5% Eye Drops and Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteCanada
Study dates
1 Sep 2024to 1 Jul 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18 years and older.
  • Diagnosed with open-angle glaucoma.
  • Intraocular pressure (IOP) greater than 16 mmHg on at least two consecutive occasions separated by one month.
  • Visual acuity of 20/200 or better in at least one eye.
  • Provided informed consent.

Who cannot join

  • Patients with any other ocular disorders or surgeries within the last six months.
  • Allergy or intolerance to ketorolac or fluorometholone.
  • Previous use of systemic ketorolac or fluorometholone in the past month.
  • Pregnancy or breastfeeding.
  • Patients who are unable to speak/understand English.
  • Any condition that in the investigator's opinion would make participation not in the best interest of the patient or could prevent, limit, or confound the protocol-specified assessments.

Trial locations and contacts

1 site in 1 country.

Sharan Bains, MD contact

(905) 573-7777 ext. 38504

bainss@mcmaster.ca

Enitan A Sogbesan, MD contact

(905) 573-7777 ext. 38311

bainss@mcmaster.ca

Canada1 site

  • St. Joseph's Healthcare Hamilton, Hamilton Regional Eye Institute

    Hamilton, Ontario, L8G 4X3

    Sharan Bains, MD, 905-522-1155 ext. 38504, bainss@mcmaster.ca

    Enitan A Sogbesan, MD, 905-573-7777 ext. 38311, sogbese@mcmaster.ca

Other trials in Canada

About this study

Official title: Comparative Efficacy of NSAID and Steroid-NSAID Combination Following Selective Laser Trabeculoplasty: a Phase 4, Single-centre, Randomized Controlled 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.

Read the detailed description

Selective Laser Trabeculoplasty (SLT) is a widely used procedure introduced by Latina and Park in 1995 for the management of various forms of glaucoma, including open-angle glaucoma (OAG), pigmentary glaucoma, pseudoexfoliation glaucoma, and ocular hypertension. SLT helps prevent irreversible blindness by effectively managing these conditions. However, postoperative management strategies vary among practitioners, with some prescribing NSAIDs, a combination of NSAIDs and steroids, or no treatment at all. There is no consensus on the most effective and safest approach.

This phase 4 single-centre randomized controlled trial seeks to address this knowledge gap by comparing the postoperative effects of ketorolac alone, a combination of ketorolac and fluorometholone, and a no treatment control group on inflammation and patient comfort following SLT. The hypothesis is that treatment with ketorolac alone or in combination with fluorometholone will show superior results in reducing inflammation and improving patient comfort compared to no treatment.

The study will enroll patients undergoing SLT at the Hamilton Regional Eye Clinic. Participants will be randomized into either one of two treatment groups or one control group (no treatment) and monitored for changes in IOP, visual acuity, patient comfort, and the occurrence of any complications over a one-year period. Data collected from these assessments will be analyzed to determine the comparative efficacy and safety of the three strategies.

Inclusion criteria include adults diagnosed with open-angle glaucoma, IOP greater than 16 mmHg, and visual acuity of 20/200 or better. Exclusion criteria include recent ocular surgeries, allergies to ketorolac or fluorometholone, and pregnancy. The primary outcome measure is the change in IOP from baseline, while secondary outcomes include visual acuity, anterior chamber inflammation, and patient-reported discomfort.

The trial follows CONSORT guidelines to maintain transparency and reproducibility. Ethical approval will be obtained from the Hamilton Integrated Research Ethics Board (HiREB), ensuring compliance with ethical and legal requirements.

The results of this study will inform postoperative care decisions following SLT, potentially leading to improved patient outcomes and satisfaction. This trial also aims to contribute to a more standardized postoperative management protocol for SLT, enhancing clinical practice and patient care in glaucoma treatment.

Being tested
Ketorolac 0.5% Eye Drops, Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops
Keywords
Selective Laser Trabeculoplasty (SLT), Non-steroidal anti-inflammatory drugs (NSAIDs), Ketorolac, Fluorometholone, Postoperative care, Intraocular pressure (IOP), Visual acuity, Glaucoma treatment, Ophthalmology, Randomized controlled trial (RCT)
Medical subject headings
Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ketorolac 0.5% Eye DropsDrug

    Also called Acular, Acular LS, Acuvail

    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 works by inhibiting cyclooxygenase (COX) enzymes, which play a key role in the inflammatory process. This intervention aims to reduce postoperative inflammation and pain, promoting patient comfort and potentially improving outcomes following SLT.

  • Ketorolac 0.5% and Fluorometholone 0.1% Eye DropsDrug

    Also called FML, Acular, Acuvail, Fluor-Op

    Participants in this arm will receive a combination of ketorolac 0.5% eye drops and fluorometholone 0.1% eye drops. Ketorolac will be administered twice daily and fluorometholone four times daily for one week following SLT. Fluorometholone is a corticosteroid that reduces inflammation by stabilizing capillary permeability and inhibiting inflammatory cell activation. The combination aims to maximize anti-inflammatory effects and enhance patient comfort, potentially leading to better postoperative outcomes compared to ketorolac alone or no treatment.

Study groups in NCT06498440
Study groupRoleWhat they receive
Ketorolac AloneExperimentalParticipants 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.
Receives: Drug: Ketorolac 0.5% Eye Drops
Ketorolac with FluorometholoneExperimentalParticipants 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.
Receives: Drug: Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops
No Treatment ControlNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Intraocular Pressure (IOP) from Baseline

    The primary outcome measure is the mean change in intraocular pressure (IOP) from baseline to 1 year post-Selective Laser Trabeculoplasty (SLT). IOP will be measured using Goldmann applanation tonometry (GAT) at each follow-up visit. The baseline IOP is determined as the average of measurements taken on the day of SLT booking and on the day of the SLT procedure. The primary objective is to compare the effectiveness of ketorolac alone, ketorolac with fluorometholone, and no treatment in reducing IOP following SLT.

    Measured: Baseline to 1 year post-SLT

Secondary outcomes (4)

  1. Visual Acuity

    Visual acuity will be measured using a Snellen chart and reported in logMAR units at each follow-up visit. The study will compare changes in visual acuity among the three treatment groups to determine the impact of each postoperative strategy on visual function.

    Measured: Baseline to 1 year post-SLT

  2. Anterior Chamber Inflammation

    Anterior chamber inflammation will be assessed using the Standardization of Uveitis Nomenclature (SUN) Working Group grading system. The presence and severity of cells and flare in the anterior chamber will be evaluated at each follow-up visit to compare the anti-inflammatory effects of the treatment strategies.

    Measured: Baseline to 1 year post-SLT

  3. Patient-Reported Discomfort

    Patient discomfort will be recorded at each follow-up visit. Participants will rate their discomfort on a scale, allowing for comparison of patient comfort levels across the three treatment groups.

    Measured: Baseline to 1 year post-SLT

  4. Incidence of Postoperative Complications

    The incidence of postoperative complications, such as ocular discomfort, conjunctival hyperemia, and corneal abrasions, will be recorded at each follow-up visit. This measure will help determine the safety profile of ketorolac alone, ketorolac with fluorometholone, and no treatment following SLT.

    Measured: Baseline to 1 year post-SLT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Model description
This study is a Phase 4 single-centre randomized controlled trial (RCT) at the Hamilton Regional Eye Clinic, St. Joseph's Healthcare Hamilton. It aims to compare postoperative treatments following Selective Laser Trabeculoplasty (SLT) in open-angle glaucoma patients. Participants are randomly assigned to one of three groups: ketorolac alone, ketorolac with fluorometholone, or no treatment (control). The primary outcome is the change in intraocular pressure (IOP) from baseline to one year post-SLT, with secondary outcomes including visual acuity, inflammation, and patient-reported discomfort. Follow-up assessments occur at 1 hour, 1 week, 1 month, 3 months, 6 months, and 1 year. The study follows CONSORT guidelines and has ethical approval from the Hamilton Integrated Research Ethics Board (HiREB). The goal is to provide reliable data on effective postoperative management strategies, enhancing clinical practice in glaucoma treatment.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06498440
Sponsor's protocol ID
17189
Acronym
CES-NSLT
Status last verified
Jul 2024
First submitted
5 Jul 2024
Last updated
12 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: The decision to share individual participant data (IPD) with other researchers is currently under consideration. The final decision will be made in alignment with institutional policies and ethical guidelines to ensure the protection of participant confidentiality and the integrity of the study.

Publications

  • Canadian Ophthalmological Society Glaucoma Clinical Practice Guideline Expert Committee; Canadian Ophthalmological Society. Canadian Ophthalmological Society evidence-based clinical practice guidelines for the management of glaucoma in the adult eye. Can J Ophthalmol. 2009;44 Suppl 1:S7-93. doi: 10.3129/cjo44s1. No abstract available. English, French.

    PubMed 19492005

  • Foster PJ, Buhrmann R, Quigley HA, Johnson GJ. The definition and classification of glaucoma in prevalence surveys. Br J Ophthalmol. 2002 Feb;86(2):238-42. doi: 10.1136/bjo.86.2.238.

    PubMed 11815354

  • Zhang N, Wang J, Li Y, Jiang B. Prevalence of primary open angle glaucoma in the last 20 years: a meta-analysis and systematic review. Sci Rep. 2021 Jul 2;11(1):13762. doi: 10.1038/s41598-021-92971-w.

    PubMed 34215769

  • Farkouh A, Frigo P, Czejka M. Systemic side effects of eye drops: a pharmacokinetic perspective. Clin Ophthalmol. 2016 Dec 7;10:2433-2441. doi: 10.2147/OPTH.S118409. eCollection 2016.

    PubMed 27994437

  • Macsai, M., & Mojica, G. (2013). Medical Management of Ocular Surface Disease. In E. J. Holland, M. J. Mannis, & W. B. Lee (Eds.), Ocular Surface Disease: Cornea, Conjunctiva and Tear Film (pp. 271-281). W.B. Saunders. https://doi.org/10.1016/B978-1-4557-2876-3.00034-1

  • Mahmoodi AN, Patel P, Kim PY. Ketorolac. 2024 Feb 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK545172/

    PubMed 31424756

  • Shin DH, Frenkel RE, David R, Cheetham JK. Effect of topical anti-inflammatory treatment on the outcome of laser trabeculoplasty. The Fluorometholone-Laser Trabeculoplasty Study Group. Am J Ophthalmol. 1996 Sep;122(3):349-54. doi: 10.1016/s0002-9394(14)72061-6.

    PubMed 8794707

  • Realini T, Charlton J, Hettlinger M. The impact of anti-inflammatory therapy on intraocular pressure reduction following selective laser trabeculoplasty. Ophthalmic Surg Lasers Imaging. 2010 Jan-Feb;41(1):100-3. doi: 10.3928/15428877-20091230-18.

    PubMed 20128578

  • Mermoud A, Pittet N, Herbort CP. Inflammation patterns after laser trabeculoplasty measured with the laser flare meter. Arch Ophthalmol. 1992 Mar;110(3):368-70. doi: 10.1001/archopht.1992.01080150066030.

    PubMed 1543456

  • Herbort CP, Mermoud A, Schnyder C, Pittet N. Anti-inflammatory effect of diclofenac drops after argon laser trabeculoplasty. Arch Ophthalmol. 1993 Apr;111(4):481-3. doi: 10.1001/archopht.1993.01090040073033.

    PubMed 8470978

  • Rebenitsch RL, Brown EN, Binder NR, Jani A, Bonham AJ, Krishna R, Pikey K. Effect of topical loteprednol on intraocular pressure after selective laser trabeculoplasty for open-angle glaucoma. Ophthalmol Ther. 2013 Dec;2(2):113-20. doi: 10.1007/s40123-013-0018-z. Epub 2013 Aug 31.

    PubMed 25135811

  • Kim YY, Glover BK, Shin DH, Lee D, Frenkel RE, Abreu MM. Effect of topical anti-inflammatory treatment on the long-term outcome of laser trabeculoplasty. Fluorometholone-Laser Trabeculoplasty Study Group. Am J Ophthalmol. 1998 Nov;126(5):721-3. doi: 10.1016/s0002-9394(98)00177-9.

    PubMed 9822239

  • Gracner T. Impact of Short-Term Topical Steroid Therapy on Selective Laser Trabeculoplasty Efficacy. J Clin Med. 2021 Sep 19;10(18):4249. doi: 10.3390/jcm10184249.

    PubMed 34575360

  • Dahlgren T, Ayala M, Zetterberg M. The impact of topical NSAID treatment on selective laser trabeculoplasty efficacy. Acta Ophthalmol. 2023 May;101(3):266-276. doi: 10.1111/aos.15276. Epub 2022 Oct 18.

    PubMed 36259097

  • Chen YS, Hung HT, Guo SP, Chang HC. Effects of anti-inflammatory treatment on efficacy of selective laser trabeculoplasty: a systematic review and meta-analysis. Expert Rev Clin Pharmacol. 2021 Dec;14(12):1527-1534. doi: 10.1080/17512433.2021.1981860. Epub 2021 Sep 24.

    PubMed 34524035

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ketorolac 0.5% Eye Drops and Ketorolac 0.5% and Fluorometholone 0.1% Eye Drops in people with Open Angle Glaucoma and Ocular Hypertension, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sharan Bains, MD ((905) 573-7777 ext. 38504, bainss@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Intraocular Pressure (IOP) from Baseline (time frame: Baseline to 1 year post-SLT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06498440, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.

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