Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNemocnice Kolín
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Bromfenac 0.09 % Ophthalmic Solution
DrugComparison of bromfenac ophthalmic solution 0.09% twice per day vs. nepafenac ophthalmic suspension 0.3% once per day vs. diclofenac ophthalmic suspension 0.1% four times per day for prevention of cystoid macular oedema associated with cataract surgery.
Nepafenac 0.3% Oph Susp
DrugComparison of bromfenac ophthalmic solution 0.09% twice per day vs. nepafenac ophthalmic suspension 0.3% once per day vs. diclofenac ophthalmic suspension 0.1% four times per day for prevention of cystoid macular oedema associated with cataract surgery.
diclofenac 0.1% ophthalmic susp.
DrugComparison of bromfenac ophthalmic solution 0.09% twice per day vs. nepafenac ophthalmic suspension 0.3% once per day vs. diclofenac ophthalmic suspension 0.1% four times per day for prevention of cystoid macular oedema associated with cataract surgery.
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: bromfenac 0.09%Active comparator 1 intervention
Group B: nepafenac 0.3%Active comparator 1 intervention
Group C: diclofenac 0.1%Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cystoid macular oedema presence
Measured as central retinal thickness in OCT (optical coherence tomography)
Time frame
From enrollment to the end of treatment at 6 weeksSecondary outcomes
1
Quality of life change with National Eye Institute Visual Function Questionnaire
Measures the dimensions of self-reported vision-targeted health status that are most important for persons who have chronic eye diseases
Time frame
From enrollment to the end of the treatment at 6 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov