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Safety and Efficacy of Intracameral Zimoxin for Prevention of Endophthalmitis After Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03244072
Recruitment Status : Not yet recruiting
First Posted : August 9, 2017
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Jason Ahee, M.D., Zion Therapeutics, LLC

Brief Summary:
Intracameral injection of 0.1% moxifloxacin solution after cataract surgery to prevent endophthalmitis

Condition or disease Intervention/treatment Phase
Endophthalmitis Drug: Moxifloxacin Drug: Placebo Phase 2 Phase 3

Detailed Description:
Subjects will receive either intracameral injection of 0.1% moxifloxacin solution or placebo after cataract surgery. They will be followed for one month to determine if there is a statistically significant difference in the incidence of endophthalmitis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Intracameral Zimoxin (0.1% Moxifloxacin Solution) for Prevention of Endophthalmitis After Cataract Surgery
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Active Comparator: Treatment group
Intracameral injection of moxifloxacin solution after cataract surgery
Drug: Moxifloxacin
Intracameral injection
Other Name: active

Placebo Comparator: Placebo group
Intracameral injection of placebo after cataract surgery
Drug: Placebo
intracameral injection
Other Name: sham




Primary Outcome Measures :
  1. Endophthalmitis after cataract surgery [ Time Frame: Subjects will undergo eye examinations at one day, one week, and one month post-operatively ]
    Subjects will be followed after cataract surgery and have post-operative eye examinations to determine if infection in the eye (endophthalmitis) occurs during the study period.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • visually significant cataracts

Exclusion Criteria:

  • allergy to fluoroquinolones

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): NCT03244072


Contacts
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Contact: Jason Ahee, M.D. 435-216-7676 aheejason@hotmail.com

Locations
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United States, Utah
Zion Eye Institute Not yet recruiting
Saint George, Utah, United States, 84790
Contact: Jason Ahee, M.D.         
Sponsors and Collaborators
Jason Ahee, M.D.
Investigators
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Principal Investigator: Jason Ahee, M.D. Zion Therapeutics, LLC

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Responsible Party: Jason Ahee, M.D., Medical Director, Zion Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT03244072     History of Changes
Other Study ID Numbers: PIND 134134
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Capsule Opacification
Eye Diseases
Eye Infections
Infection
Moxifloxacin
Anti-Bacterial Agents
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