Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen
|ClinicalTrials.gov Identifier: NCT03578276|
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : July 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Drug: Pred-Gati-Brom Drug: Prednisolone acetate 1% ophthalmic suspension Drug: Gatifloxacin Ophthalmic Drug: Bromfenac 0.075% Oph Solution||Phase 4|
Cataract surgery is one of the most commonly performed surgeries in the world today. To improve the overall procedure outcome, prophylactic topical antibiotics and anti-inflammatories (steroidal and non-steroidal, NSAID) are frequently used to decrease the risk of postoperative infection (e.g., endophthalmitis) and intraocular inflammation (e.g., macular edema, CME).
Even though, the large body of literature that supports the significance of prophylactic eye drops prior to surgery, patient compliance is a common problem. Different factors have been associated with patient's lack of compliance. It could be due to patient's inability to self- administer the drops, lack of understanding of the importance of using the prophylactic treatment as well as understanding the instructions of how to administer the drops and its storage, or just forgetfulness or the fact that they don't like to put the drops multiple times a day for 2-4 weeks, therefore they just avoid doing it. About 64% of patients adhere to the prescribed treatment.
There is a new alternative that combines the most commonly used antibiotic and anti-inflammatories into a single drop. The use of a single drop compounded ophthalmic solution may offer advantages such as increased compliance, patient comfort and reduced ocular toxicity. T
The purpose of this study is to compare the Pred-Gati-Brom formulation to the standard topical drops regimen that includes the topical use of Gatifloxacin, Bromfenac and Prednisolone acetate 1%.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants' eyes are assigned to one of two groups.|
|Masking:||None (Open Label)|
|Official Title:||Lessdrops™ Prophylactic Treatment After Routine Phacoemulsification Compared to Standard Drops Regimen|
|Actual Study Start Date :||June 22, 2018|
|Estimated Primary Completion Date :||June 15, 2019|
|Estimated Study Completion Date :||June 15, 2019|
Active Comparator: LessDrops
Compounded eye drop containing Gatifloxacin (antibiotic), bromfenac (non-steroidal anti-inflammatory), and prednisolone acetate 1% used three times a day (TID) starting 1 day prior to surgery and continuing after surgery for 2 weeks then twice a day for a week and once a day for another week.
The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%
Other Name: LessDrops
Active Comparator: Standard of Care
Drug: Prednisolone acetate 1% ophthalmic suspension
Drug: Gatifloxacin Ophthalmic
Drug: Bromfenac 0.075% Oph Solution
- Change From Baseline (Preoperative Exam) in Macular Thickness [ Time Frame: Month 1 ]Thickness of the macula measured in microns
- Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness) [ Time Frame: Month 1 ]Thickness of the cornea measured in microns
- Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP) [ Time Frame: Day 1, Day 15 and Day 30. ]Measurement of the pressure inside the eye in mmHg
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): NCT03578276
|Contact: Helga P Sandovalfirstname.lastname@example.org|
|United States, South Carolina|
|Carolina Eyecare Physicians, LLC||Recruiting|
|Mount Pleasant, South Carolina, United States, 29464|
|Contact: Helga P Sandoval, MD, MSCR 843-881-3937 email@example.com|
|Principal Investigator: Kerry D Solomon, MD|
|Sub-Investigator: Jefrrey F Hood, OD|
|Principal Investigator:||Kerry Solomon, MD||Carolina Eyecare Physicians, LLC|