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Trial record 9 of 19 for:    "Lens Disease" | "Estradiol"

Intracameral Antibiotic Safety Study

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ClinicalTrials.gov Identifier: NCT02590523
Recruitment Status : Not yet recruiting
First Posted : October 29, 2015
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Sloan W. Rush, MD, Panhandle Eye Group, LLP

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.

Condition or disease Intervention/treatment Phase
Intracameral Antibiotics Cataract Surgery Phacoemulsification Endophthalmitis Vancomycin Moxifloxacin Drug: Vancomycin Drug: Moxifloxacin Drug: Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Intracameral Antibiotic Safety Study
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Cataract

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




Primary Outcome Measures :
  1. Occurrence of adverse event [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Postoperative visual acuity measured by best spectacle corrected [ Time Frame: 3 months ]
    best spectacle corrected


Other Outcome Measures:
  1. Endothelial cell count measured by specular microscopy [ Time Frame: 3 months ]
    specular microscopy

  2. Rate of postoperative complication [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590523


Contacts
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Contact: Sloan Rush, MD 806-353-0125 sloan.rush@paneye.com
Contact: Sunday Fowler 806-353-0125 sunday.fowler@paneye.com

Sponsors and Collaborators
Panhandle Eye Group, LLP

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Responsible Party: Sloan W. Rush, MD, Physician, Panhandle Eye Group, LLP
ClinicalTrials.gov Identifier: NCT02590523     History of Changes
Other Study ID Numbers: 3
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lens Diseases
Norgestimate, ethinyl estradiol drug combination
Endophthalmitis
Cataract
Eye Diseases
Eye Infections
Infection
Anti-Bacterial Agents
Moxifloxacin
Vancomycin
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs