Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Drug: Pred-Gati-Brom; Drug: Prednisolone acetate 1% ophthalmic suspension; Drug: Gatifloxacin Ophthalmic; Drug: Bromfenac 0.075% Oph Solution

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%.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Carolina EyeCare Physicians, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is undergoing bilateral cataract extraction or refractive lens exchange with intraocular lens implantation.
• Willing and able to provide written informed consent for participation in the study.
• Willing and able to comply with scheduled visits and other study procedures.
• Willing and able to administer eye drops and record the times the drops were instilled.
• Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-15 days between surgeries.
• Potential postoperative best-corrected visual acuity of 20/30 or better.

Exclusion Criteria:

• Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, advanced macular degeneration, advanced glaucomatous damage, etc.
• Uncontrolled diabetes.
• Use of any systemic or topical drug known to interfere with visual performance.
• Contact lens use during the active treatment portion of the trial.
• Any concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis.
• History of chronic intraocular inflammation.
• History of retinal detachment.
• Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
• Any additional ocular surgical procedures at time of cataract extraction (i.e. iStent) except corneal incisions for the correction of astigmatism.
• Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
• Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
• Participation in (or current participation) any ophthalmic investigational drug or device trial within the previous 30 days prior to the start date of this trial.
• Intraocular conventional surgery within the past three months or intraocular laser surgery within one month.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Pred-Gati-Brom; The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%; Other Names: LessDrops
ACTIVE_COMPARATOR: Standard of Care; Gatifloxacin 0.5%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.; Bromfenac 0.07%: 1 drop QD starting 3 days before surgery, continue QD for 4 weeks after surgery and then discontinue.; Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinue.	Drug: Prednisolone acetate 1% ophthalmic suspension; Steroidal anti-inflammatory; Drug: Gatifloxacin Ophthalmic; Antibiotic; Drug: Bromfenac 0.075% Oph Solution; Non-steroidal anti-inflammatory

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline (Preoperative Exam) in Macular Thickness	Thickness of the macula measured in microns, recorded as the change from baseline.	Month 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)	Thickness of the cornea measured in microns, measured as the change from baseline	Month 1
Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)	Measurement of the pressure inside the eye in mmHg, recorded as the change from baseline	Month 1

Collaborators and Investigators

• Sponsor: Carolina Eyecare Physicians, LLC
• Collaborators: Science in Vision; Imprimis Pharmaceuticals, Inc.
• Investigators: Principal Investigator: Kerry Solomon, MD, Carolina EyeCare Physicians, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 22, 2018
• Primary Completion (ACTUAL): December 4, 2019
• Study Completion (ACTUAL): December 4, 2019

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (ACTUAL): July 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: cataract surgery; Prophylaxis
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Gatifloxacin; Bromfenac
• Other Study ID Numbers: CEP 2016-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No