Which eye drop—bromfenac, nepafenac, or diclofenac—works best after cataract surgery?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults scheduled for cataract surgery are randomly assigned to one of three topical NSAID regimens given before and after the operation. Participants return for follow-up visits on day 1, week 1, week 3, and week 6 when investigators measure retinal thickness with OCT, record best-corrected visual acuity, and collect quality-of-life questionnaires. The study compares the incidence and severity of cystoid macular edema and records adverse events for each drug. Outcomes will determine relative efficacy and tolerability of the three commonly used ophthalmic NSAIDs in this surgical setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Are male or female at least 18 years of age who require cataract surgery and no other surgical procedures during the cataract surgery.
* Agree not to have any other ocular surgical procedures in the study or fellow (non study) eye within 15 days prior to the initiation of dosing with the test article or throughout the duration of the study.
* Have a Best Corrected Visual Acuity of 20/200 or better in either eye.
* Are able to self administer test article (or have a caregiver available to instill all doses of test article).

Exclusion Criteria:

* Have known hypersensitivity to bromfenac, nepafenac, diclofenac or any component of the test article (including "procedural" medications such as anesthetic and/or fluorescein drops, dilating drops, etc.).
* Have intraocular inflammation (i.e., cells or flare in the anterior chamber as measured on slit lamp examination) in study eye at screening visit.
* Have a known blood dyscrasia or bone marrow suppression, a diagnosis of uncontrolled/unstable peptic ulcer disease, inflammatory bowel disease, or ulcerative colitis, or any uncontrolled/unstable pulmonary, cardiac, vascular, autoimmune, hepatic, renal, or central nervous system disease.
* Have used ocular, topical, or systemic NSAIDs or ocular, topical, or systemic gentamicin, or cyclosporine ophthalmic emulsion within 7 days prior to initiation of dosing with the test article or throughout the duration of study,with exception of allowing patients on a stable dose of aspirin 81 mg daily or less.
* Have diabetes of any type.
* Have any pathology of vitreoretinal interface (recognised on opcital coherence tomography).
* Have any history of pars plana vitrectomy in the study eye.
* Have glaucoma of the following types: any secondary, closed angle, severe open angle.
* Have used ocular prostaglandins within 30 days prior to initiation of dosing with test article or throughout the duration of study.
* Have active corneal pathology noted in the study eye at screening visit. Active corneal pathology is defined as corneal pathology that is non stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment. Superficial punctate keratitis in study eye.
* Have any extraocular/intraocular inflammation in the study eye at screening visit (blepharitis allowed if mild only, and no concurrent conjunctivitis or lid erythema/edema) or ongoing, unresolved uveitis.
* Have used topical, ocular, inhaled or systemic steroids within 14 days prior to screening.
* Have a history of abuse of alcohol/drugs within six months prior to the screening visit.
* Are pregnant or nursing/lactating.
* Have participated in any other study of an investigational drug or device within 30 days prior to randomization.

Where it's running

• Oblastní nemocnice Kolín a.s.
  Kolín, Czechia Recruiting

Study contacts

• Study coordinator: Tomas Vanek
• Email: tomas.vanek@nemocnicekolin.cz
• Phone: +420728872150

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.