Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen

NCT ID: NCT03578276

Last Updated: 2022-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-22
• Study Completion Date: 2019-12-04

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Pred-Gati-Brom

Intervention Type: DRUG

The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%

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.

Group Type: ACTIVE_COMPARATOR

Prednisolone acetate 1% ophthalmic suspension

Intervention Type: DRUG

Steroidal anti-inflammatory

Gatifloxacin Ophthalmic

Intervention Type: DRUG

Antibiotic

Bromfenac 0.075% Oph Solution

Intervention Type: DRUG

Non-steroidal anti-inflammatory

Interventions

Pred-Gati-Brom

The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%

Intervention Type: DRUG

Prednisolone acetate 1% ophthalmic suspension

Steroidal anti-inflammatory

Intervention Type: DRUG

Gatifloxacin Ophthalmic

Antibiotic

Intervention Type: DRUG

Bromfenac 0.075% Oph Solution

Non-steroidal anti-inflammatory

Intervention Type: DRUG

Other Intervention Names

LessDrops

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Science in Vision

OTHER

Sponsor Role: collaborator

Imprimis Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Carolina Eyecare Physicians, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kerry Solomon, MD

Role: PRINCIPAL_INVESTIGATOR

Carolina Eyecare Physicians, LLC

Locations

Carolina Eyecare Physicians, LLC

Mt. Pleasant, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CEP 2016-001

Identifier Type: -

Identifier Source: org_study_id