Dropless vs. Standard Drops Contralateral Eye Study

NCT02515045 | Completed Phase 4 Results

• 1 other identifier: CEP 14-002
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 4

Brief Summary

To compare the use of an injectable compound containing an antibiotic and an anti-inflammatory at time of cataract surgery to standard of care that is the use 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

  Macula is the area in the retina that is responsible for the best central vision. Changes in its thickness may occur after cataract surgery due to the normal inflammatory process that occurs postoperatively but it returns to preoperative values unless there is an underlying disease.

  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 (3)

TriMoxiVanc

ACTIVE COMPARATOR

The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.

Drug: TriMoxiVanc

TriMoxiVanc + Ilevro

ACTIVE COMPARATOR

Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.

Drug: TriMoxiVanc; Drug: Ilevro

Control

ACTIVE COMPARATOR

Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue. Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.

Drug: Moxifloxacin HCl 0.5%; Drug: Ilevro; Drug: Prednisolone acetate 1%

Interventions

TriMoxiVanc DRUG

triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.

Also known as: Dropless

TriMoxiVanc; TriMoxiVanc + Ilevro

Moxifloxacin HCl 0.5% DRUG

Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.

Also known as: Vigamox, Moxeza

Control

Ilevro DRUG

NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.

Also known as: Nepafenac 0.3%

Control; TriMoxiVanc + Ilevro

Prednisolone acetate 1% DRUG

Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.

Also known as: Pred Forte, Econopred Plus, Omnipred

Control

Eligibility Criteria

• Age: 50 Years - 80 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, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
• Presence of epiretinal membrane.
• 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/non infectious 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.
• Previous radial keratotomy.
• 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 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

Study Sites (4)

Minnesota Eye Consultants, P.A.

Bloomington, Minnesota, 55431, United States

Location

Associated Eye Care

Stillwater, Minnesota, 55082, United States

Location

Ophthalmic Consultants of Long Island

Garden City, New York, 11530, United States

Location

Carolina Eyecare Physicians, LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Moxifloxacin; nepafenac; prednisolone acetate; Methylprednisolone

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Helga P. Sandoval, MD, MSCR. Director of Research
• Organization: Carolina Eyecare Physicians, LLC

helga.sandoval@carolinaeyecare.com

8438813937

Study Officials

• Kerry D Solomon, MD

  Carolina Eyecare Physicians, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: August 4, 2015
• Study Start: January 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 23, 2018
• Results First Posted: August 22, 2017

Record last verified: 2018-01

Locations

US (4)