Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen

NCT03578276 | Completed Phase 4 Results FDA Drug

• 1 other identifier: CEP 2016-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

cataract surgery; Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (Preoperative Exam) in Macular Thickness

  Thickness of the macula measured in microns, recorded as the change from baseline.

  Month 1

Secondary Outcomes (2)

• Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)

  Month 1

• Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)

  Month 1

Study Arms (2)

LessDrops

ACTIVE COMPARATOR

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

Standard of Care

ACTIVE COMPARATOR

* 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; Drug: Gatifloxacin Ophthalmic; Drug: Bromfenac 0.075% Oph Solution

Interventions

Pred-Gati-Brom DRUG

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

Also known as: LessDrops

LessDrops

Prednisolone acetate 1% ophthalmic suspension DRUG

Steroidal anti-inflammatory

Standard of Care

Gatifloxacin Ophthalmic DRUG

Antibiotic

Standard of Care

Bromfenac 0.075% Oph Solution DRUG

Non-steroidal anti-inflammatory

Standard of Care

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carolina Eyecare Physicians, LLC: lead
• Science in Vision: collaborator
• Imprimis Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Carolina Eyecare Physicians, LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

prednisolone acetate; bromfenac

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Director of Research
• Organization: Carolina Eyecare Physicians, LLC

hps@cepmd.com

8438813937

Study Officials

• Kerry Solomon, MD

  Carolina Eyecare Physicians, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants' eyes are assigned to one of two groups.

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 6, 2018
• Study Start: June 22, 2018
• Primary Completion: December 4, 2019
• Study Completion: December 4, 2019
• Last Updated: June 10, 2022
• Results First Posted: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)