Macular OedemaBNDNCT07178639
Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery
A study testing Bromfenac 0.09 % Ophthalmic Solution, Nepafenac 0.3% Oph Susp and diclofenac 0.1% ophthalmic susp. in people with Macular Oedema and Cataract Surgery, run by Nemocnice Kolín at 1 site in Czechia.
Trial 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 cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Oedema, Cataract Surgery, NSAID (Non-Steroidal Anti-Inflammatory Drug)
- What is being tested?
- Bromfenac 0.09 % Ophthalmic Solution, Nepafenac 0.3% Oph Susp and diclofenac 0.1% ophthalmic susp.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Aug 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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).
Who cannot join
- 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).
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Oblastní nemocnice Kolín a.s.
Kolín, 28002
Tomas Vanek, +420728872150, tomas.vanek@nemocnicekolin.cz
tomas.vanek@nemocnicekolin.cz
About this study
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:
Read more
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.
- Being tested
- Bromfenac 0.09 % Ophthalmic Solution, Nepafenac 0.3% Oph Susp, diclofenac 0.1% ophthalmic susp.
- Keywords
- macular oedema, cataract surgery, macular oedema treatment
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bromfenac 0.09 % Ophthalmic SolutionDrug
Also called Bromfenac 0.09 %
Comparison 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 SuspDrug
Also called Nepafenac 0.3%
Comparison 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.Drug
Also called diclofenac 0.1%
Comparison 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.
| Study group | Role | What they receive |
|---|---|---|
| bromfenac 0.09% | Active comparator | Subjects will instill one drop into the study (operative) eye twice per day for a maximum of 26 days. Dosing will begin four days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery. Receives: Drug: Bromfenac 0.09 % Ophthalmic Solution |
| nepafenac 0.3% | Active comparator | Subjects will instill one drop into the study (operative) eye once per day for a maximum of 26 days. Dosing will begin four days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery. Receives: Drug: Nepafenac 0.3% Oph Susp |
| diclofenac 0.1% | Active comparator | Subjects will instill one drop into the study (operative) eye four times per day for a maximum of 26 days. Dosing will begin four days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery. Receives: Drug: diclofenac 0.1% ophthalmic susp. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cystoid macular oedema presence
Measured as central retinal thickness in OCT (optical coherence tomography)
Measured: From enrollment to the end of treatment at 6 weeks
Secondary 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
Measured: From enrollment to the end of the treatment at 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start1 Aug 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular OedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nemocnice Kolín
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomas Vanek, Nemocnice Kolín
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178639
- Sponsor's protocol ID
- 2025-001
- Other IDs
- 2025-001
- Acronym
- BND
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery
- ClinicalTrials.gov ID
- NCT07178639
- Acronym / sponsor ID
- BND / 2025-001
- Keywords
- macular oedema, cataract surgery, macular oedema treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Nemocnice KolínUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bromfenac 0.09% | Active comparator | Drug: Bromfenac 0.09 % Ophthalmic SolutionSubjects will instill one drop into the study (operative) eye twice per day for a maximum of 26 days. Dosing will begin four days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery. |
| nepafenac 0.3% | Active comparator | Drug: Nepafenac 0.3% Oph SuspSubjects will instill one drop into the study (operative) eye once per day for a maximum of 26 days. Dosing will begin four days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery. |
| diclofenac 0.1% | Active comparator | Drug: diclofenac 0.1% ophthalmic susp.Subjects will instill one drop into the study (operative) eye four times per day for a maximum of 26 days. Dosing will begin four days prior to surgery (Day 3), continue on the day of surgery and for 21 days after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bromfenac 0.09 % Ophthalmic SolutionAlso: Bromfenac 0.09 %Comparison 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. | Drug | bromfenac 0.09% |
| Nepafenac 0.3% Oph SuspAlso: Nepafenac 0.3%Comparison 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. | Drug | nepafenac 0.3% |
| diclofenac 0.1% ophthalmic susp.Also: diclofenac 0.1%Comparison 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. | Drug | diclofenac 0.1% |
Primary outcome
Cystoid macular oedema presence
Time frame: From enrollment to the end of treatment at 6 weeks
Measured as central retinal thickness in OCT (optical coherence tomography)
1 secondary outcome
Quality of life change with National Eye Institute Visual Function Questionnaire
Time frame: From enrollment to the end of the treatment at 6 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bromfenac 0.09 % Ophthalmic Solution, Nepafenac 0.3% Oph Susp and diclofenac 0.1% ophthalmic susp. in people with Macular Oedema and Cataract Surgery, run by Nemocnice Kolín at 1 site in Czechia.
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 4 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 17 Sep 2025. 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 Czechia. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tomas Vanek (+420728872150, tomas.vanek@nemocnicekolin.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cystoid macular oedema presence (time frame: From enrollment to the end of treatment at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2025.