Intracameral Antibiotic Safety Study

NCT02590523 | Suspended Phase 3 FDA Drug

• 1 other identifier: 3
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Occurrence of adverse event

  3 months

Secondary Outcomes (1)

• Postoperative visual acuity measured by best spectacle corrected

  3 months

Other Outcomes (2)

• Endothelial cell count measured by specular microscopy

  3 months

• Rate of postoperative complication

  3 months

Study Arms (3)

A: Vancomycin

EXPERIMENTAL

Intracameral vancomycin injection given at conclusion of cataract case

Drug: Vancomycin

B: Moxifloxacin

EXPERIMENTAL

Intracameral moxifloxacin injection given at conclusion of cataract case

Drug: Moxifloxacin

C: Placebo

PLACEBO COMPARATOR

Intracameral placebo injection with BSS given at conclusion of cataract case

Drug: Placebo

Interventions

Vancomycin DRUG

Intracameral vancomycin injection during cataract surgery

A: Vancomycin

Moxifloxacin DRUG

Intracameral moxifloxacin injection during cataract surgery

B: Moxifloxacin

Placebo DRUG

Intracameral placebo injection with BSS during cataract surgery

C: Placebo

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Panhandle Eye Group, LLP: lead

Study Sites (1)

Rush Eye

Amarillo, Texas, 79106, United States

Location

MeSH Terms

Conditions

Endophthalmitis

Interventions

Vancomycin; Moxifloxacin

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Eye Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: October 29, 2015
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: April 27, 2022

Record last verified: 2022-04

Locations

US (1)