Intracameral Antibiotic Safety Study

The goal of this study is to determine the safety (but not efficacy in preventing infection) of sterile-packaged and pre-loaded injectable solutions of both vancomycin and moxifloxacin at certain dosages and concentrations as prepared by a compounding pharmacy when used intracamerally at the time of cataract surgery.

Study Overview

• Status: Suspended
• Conditions: Endophthalmitis; Cataract Surgery; Phacoemulsification; Vancomycin; Intracameral Antibiotics; Moxifloxacin
• Intervention / Treatment: Drug: Vancomycin; Drug: Moxifloxacin; Drug: Placebo

Detailed Description

Use of injectable prophylactic intracameral antibiotics during cataract surgery is gaining popularity worldwide due to the growing body of scientific evidence supporting its use. To date, there is no sterile-packaged antibiotic that has FDA approval for this indication. Surgeons using intracameral injectable antibiotics during cataract surgery must use existing pharmaceuticals off-label and/or rely on imprecise and sub-sterile compounding pharmacies to dispense these types of medications. Both of these scenarios may pose significant risk to patient safety.

Description of the Treatment: Approximately 0.2 mL of either pre-loaded sterile vancomycin hydrochloride 1% solution (1 mg/0.1 mL of normal saline) or moxifloxacin hydrochloride 0.15% solution (150 μg/0.1 mL of normal saline) is injected into the eye with a blunt tip 30 gauge cannula through a small clear corneal incision as the last step in the cataract removal procedure. The purpose of the treatment is for prophylaxis against post-operative infections and endophthalmitis.

Description of Effector Pharmaceuticals/Drugs: Vancomycin is a hydrophilic glycopeptide antibiotic that has been well studied in many different forms: intravenous injectable, oral tablet and even topical eye drop solutions. It is derived from Actinobacteria spp. Moxifloxacin is a synthetic fourth generation fluoroquinolone and has, likewise, been available in many forms including intravenous injectable, oral tablet and topical eye drop solutions. In this study, a contracted compounding pharmacy will produce the two pharmaceutical agents at the concentration/dosage mentioned above under the USP 797 guidelines.

Therapeutic Mode of Action: The primary mode of action for vancomycin is inhibition of cell wall synthesis in gram positive bacteria. The molecule forms hydrogen bonds with terminal amnio acid moieties of the N-acetylmuramic acid (NAM) and N-acetylglucosamine (NAG) polymer. The disruption to the polymerization and cross-linking of NAM-NAG complexes undermines the structural integrity of the bacterial organism leading to bacteriostasis and eventually cell death. The primary mode of action for moxifloxacin is inhibiting DNA gyrases, both type II topoisomerase and topoisomerase IV. These enzymes are essential for bacterial DNA replication to occur.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Amarillo, Texas, United States, 79106
      • Rush Eye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of visually significant cataract
• Appropriate candidate for cataract surgery

Exclusion Criteria:

• Not willing to undergo an investigational treatment or are unable to cooperate well enough to safely perform the procedure under the protocol guidelines
• Has known allergies to the pre-/intra-/post-operative medications or preservatives in the medications will also be excluded
• Has significant ocular co-morbidities in one or both eyes which may include (but is not limited to): advanced glaucoma, advanced or active macular degeneration, Fuchs corneal dystrophy, prior corneal transplantation, advanced diabetic eye disease, history of retinal detachment or any patient that would require billing a complex cataract procedure for any reason
• Has a known history of a condition which causes an immuno-compromised host state

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A: Vancomycin; Intracameral vancomycin injection given at conclusion of cataract case	Drug: Vancomycin; Intracameral vancomycin injection during cataract surgery
Experimental: B: Moxifloxacin; Intracameral moxifloxacin injection given at conclusion of cataract case	Drug: Moxifloxacin; Intracameral moxifloxacin injection during cataract surgery
Placebo Comparator: C: Placebo; Intracameral placebo injection with BSS given at conclusion of cataract case	Drug: Placebo; Intracameral placebo injection with BSS during cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of adverse event	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative visual acuity measured by best spectacle corrected	best spectacle corrected	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial cell count measured by specular microscopy	specular microscopy	3 months
Rate of postoperative complication		3 months

Collaborators and Investigators

• Sponsor: Panhandle Eye Group, LLP

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: October 27, 2015
• First Submitted That Met QC Criteria: October 27, 2015
• First Posted (Estimate): October 29, 2015

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Eye Diseases; Lens Diseases; Eye Infections; Cataract; Endophthalmitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Vancomycin; Moxifloxacin
• Other Study ID Numbers: 3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No