Intracameral Antibiotic Safety Study

Cataract Surgery Clinical Trial

Official title:

Intracameral Antibiotic Safety Study

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02590523
• Other study ID #: 3
• Status: Suspended
• Phase: Phase 3
• Start date: January 2023
• Est. completion date: January 2024

Study information

• Verified date: April 2022
• Source: Panhandle Eye Group, LLP
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 500
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Cataract Surgery
• Endophthalmitis
• Intracameral Antibiotics
• Moxifloxacin
• Phacoemulsification
• Vancomycin

Intervention

Drug:
• Vancomycin
Intracameral vancomycin injection during cataract surgery
• Moxifloxacin
Intracameral moxifloxacin injection during cataract surgery
• Placebo
Intracameral placebo injection with BSS during cataract surgery

Locations

Country	Name	City	State
United States	Rush Eye	Amarillo	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Panhandle Eye Group, LLP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Endothelial cell count measured by specular microscopy	specular microscopy	3 months
Other	Rate of postoperative complication		3 months
Primary	Occurrence of adverse event		3 months
Secondary	Postoperative visual acuity measured by best spectacle corrected	best spectacle corrected	3 months