Bromfenac 0.09% Versus Dexamethasone 0.1% Ophthalmic Solutions to Reduce Inflammation After Cataract Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- Flare to baseline
Study Overview
Brief Summary
The aim of the study is to compare bromfenac to dexamethasone eye drops to control inflammation after cataract surgery. Inflammation in the anterior chamber of the eye will be measured by a Laser Flare Photometer (LFP).
Detailed Description
The BVD study is a phase IV, single centre, randomized, active-control, parallel design, open-label trial comparing Bromfenac ophthalmic solution 0.1% and Dexamethasone ophthalmic suspension 0.1% in patients older than 60 years after unilateral cataract surgery.
A total of 76 patients (38 for each arm) will be included in this study. Patients will be selected among subjects who underwent cataract surgery the day before the study enrolment. Enrolment will take place at the participating hospital.
Eligible subjects will be sequentially assigned, according to a computer-generated randomization list (1:1), to one of the following treatment groups:
- Experimental Arm: Bromfenac ophthalmic solution 0.1% eye drops, 2 times per day in the study eye for two weeks;
- Standard Arm: Dexamethasone ophthalmic suspension 0.1% eye drops, 4 times per day in the study eye for the first week and 2 times per day in the study eye for the second week.
Each group must start the drops the day after cataract surgery, for two weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Bromfenac
Patients randomized to this arm will receive Bromfenac 0.09 % Ophthalmic Solution BID for 2 weeks
Intervention: Bromfenac 0.09 % Ophthalmic Solution (Drug)
Dexamethasone
Patients randomized to this arm will receive Dexamethasone 0.1 % Ophthalmic Suspension QID for one week and BID for the following week
Intervention: Dexamethasone 0.1% ophthalmic suspension (Drug)
Outcomes
Primary Outcomes
Flare to baseline
Time Frame: Within one month
Time needed to revert the postoperative flare (measured by laser flare meter in the anterior chamber of the eye) to the preoperative or lower level.
Flare at day 14
Time Frame: 14 days
Proportion of patients who will have a postoperative flare at day 14 equal or inferior to the preoperative value in the two groups
Secondary Outcomes
- Macular thickness at optical coherence tomography (OCT)(1 month)
- Ocular Comfort Grading Assessment (OCGA)(14 days)
- Best Corrected Visual Acuity (BCVA)(14 days)