Bromfenac Versus Dexamethasone After Cataract Surgery (BVD)
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|ClinicalTrials.gov Identifier: NCT03317847|
Recruitment Status : Active, not recruiting
First Posted : October 23, 2017
Last Update Posted : June 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Inflammation Eye||Drug: Bromfenac 0.09 % Ophthalmic Solution Drug: Dexamethasone 0.1% ophthalmic suspension||Phase 4|
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.
The first post-operative clinical evaluation is planned the day after cataract surgery. The following procedures will be performed on the study eye and data will be collected during this first clinical encounter:
- Eye Drops Usage training
- Concomitant medications
- Best-corrected Visual Acuity
- Laser Flare Photometry
- Slit lamp biomicroscopy
- Intracular pressure (IOP) with pneumotonometer,
- Dilated fundus ophthalmoscopy
- Ocular Comfort Grading Assessment
At least six post-operative follow-up visits are planned after 3, 7, 9, 11, 14 days (±1 day) and 30 days (±3 days) from cataract extraction plus possible adjunctive controls if problems/complications will occur. The following procedures will be performed on the study eye and data will be collected during all clinical encounters:
- Compliance with study medication
- Concomitant medications
- Best-corrected Visual Acuity (only day 7, 14, 30)
- Laser Flare Photometry
- Optical Coherence Tomography testing (only day 30)
- Slit lamp biomicroscopy (only day 7, 14 and 30)
- IOP with pneumotonometer (only day 7, 14 and 30)
- Dilated fundus ophthalmoscopy (only day 30)
- Ocular Comfort Grading Assessment (only day 7, 14 and 30)
- Adverse events
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Bromfenac 0.09% Versus Dexamethasone 0.1% Ophthalmic Solutions to Reduce Inflammation After Cataract Surgery|
|Actual Study Start Date :||October 16, 2017|
|Actual Primary Completion Date :||June 14, 2018|
|Estimated Study Completion Date :||December 2018|
Patients randomized to this arm will receive Bromfenac 0.09 % Ophthalmic Solution BID for 2 weeks
Drug: Bromfenac 0.09 % Ophthalmic Solution
Patients will self-administer 1 drop of Bromfenac twice daily to the affected eye beginning 1 day after cataract surgery and then continuing through the first 14 days of the postoperative period.
Other Name: Yellox
Active Comparator: Dexamethasone
Patients randomized to this arm will receive Dexamethasone 0.1 % Ophthalmic Suspension QID for one week and BID for the following week
Drug: Dexamethasone 0.1% ophthalmic suspension
Patients will self-administer 1 drop of Dexamethasone to the study eye beginning 1 day after cataract surgery 4 times daily during the first postoperative week and 2 times daily in the second postoperative week.
- 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
- Best Corrected Visual Acuity (BCVA) [ Time Frame: 14 days ]Proportion of subjects with BCVA equal to 10/10 at day 14 in the two groups
- Macular thickness at optical coherence tomography (OCT) [ Time Frame: 1 month ]Proportion of patients with central macular thickness greater than 300 microns at day 30 in the two groups
- Ocular Comfort Grading Assessment (OCGA) [ Time Frame: 14 days ]Safety endpoint: proportion of patients with no ocular discomfort at day 14. Ocular discomfort will be assessed by the OCGA scale. The OCGA measures 7 ocular symptoms (eye pain, tearing, itching, foreign body sensation, photophobia, eye discharge, haziness); at visits, patients will assess the severity by grading each symptom as none (0), mild (1), moderate (2), or severe (3)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317847
|Arcispedale Santa Maria Nuova IRCSS - Ophthalmology|
|Reggio Emilia, RE, Italy, 42123|
|Principal Investigator:||Marco Coassin, MD PhD||Santa Maria Nuova Hospital IRCCS|
|Study Chair:||Luigi Fontana||Santa Maria Nuova Hospital IRCCS|