NCT07178639Recruiting
Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery
Source: ClinicalTrials.gov · Last updated 17 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 cataract surgery. The main questions it aims to answer are: Which of the drugs has better efficacy in macular oedema prevention? What medical problems do participants have when taking different drugs? Researchers will compare drugs to each other. Participants will: Take on of the drugs (randomized) as their treatment in preoperative and postoperative period. Visit the clinic after the surgery on the first day, first week, in three weeks and in six weeks. Undergo retina examination with OCT (optical coherence tomography), best vision, and fill in forms considering their quality of life.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 9 Jul 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 28 Feb 2026
- Lead sponsor
- Nemocnice Kolín
- NCT number
- NCT07178639
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 1 Aug 2025 to the primary completion date, 28 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 used ocular prostaglandins within 30 days prior to initiation of dosing with test article or throughout the duration of study.
- 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.
- Have participated in any other study of an investigational drug or device within 30 days prior to randomization.
Other illness
- 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 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 diabetes of any type.
- Have any history of pars plana vitrectomy in the study eye.
Other
- 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 any pathology of vitreoretinal interface (recognised on opcital coherence tomography).
- Have glaucoma of the following types: any secondary, closed angle, severe open angle.
- 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.
- Are pregnant or nursing/lactating.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oblastní nemocnice Kolín a.s. Coordinator of this site? Confirm its status | Kolín | Czechia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.