NCT03578276

Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen

Lessdrops™ Prophylactic Treatment After Routine Phacoemulsification Compared to Standard Drops Regimen

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Carolina Eyecare Physicians, LLC · Academic / Other
• Sex: All
• Age: 50 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

To compare the use of a compounded eye drop containing an antibiotic, a non-steroidal and steroidal anti-inflammatory to standard of care that is the use of 3 different topical medications to prevent inflammation and infection after routine cataract surgery.

Detailed description

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%.

Conditions

• Cataract

Interventions

Type	Name	Description
DRUG	Pred-Gati-Brom	The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%
DRUG	Prednisolone acetate 1% ophthalmic suspension	Steroidal anti-inflammatory
DRUG	Gatifloxacin Ophthalmic	Antibiotic
DRUG	Bromfenac 0.075% Oph Solution	Non-steroidal anti-inflammatory

Timeline

• Start date: 2018-06-22
• Primary completion: 2019-12-04
• Completion: 2019-12-04
• First posted: 2018-07-06
• Last updated: 2022-06-10
• Results posted: 2022-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study