Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery

Status: Recruiting
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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. 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Contact Information
Primary
Tomas Vanek
tomas.vanek@nemocnicekolin.cz
+420728872150
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 150
Treatments
Active_comparator: bromfenac 0.09%
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.
Active_comparator: nepafenac 0.3%
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.
Active_comparator: diclofenac 0.1%
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.
Related Therapeutic Areas
Sponsors
Leads: Nemocnice Kolín

This content was sourced from clinicaltrials.gov