Status:
RECRUITING
Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery
Lead Sponsor:
Nemocnice Kolín
Conditions:
Macular Oedema
Cataract Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn which of the drugs bromfenac 0.09%, nepafenac 0.3% and diclofenac 0.1% has better efficacy in treatment and prevention of cystoid macular oedema after catar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT07178639
Start Date
August 1 2025
End Date
February 28 2026
Last Update
September 17 2025
Active Locations (1)
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1
Oblastní nemocnice Kolín a.s.
Kolín, Czechia, 28002