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Safety and Efficacy of Vancomycin Ophthalmic Ointment in Patients With Moderate to Severe Bacterial Conjunctivitis

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02432807
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Kurobe LLC

Brief Summary:
This is a Phase 3 study to evaluate the safety and efficacy of a vancomycin hydrochloride ophthalmic ointment dosed 4 times daily for 7 days compared to placebo (vehicle) in patients with moderate to severed Gram-positive bacterial conjunctivitis.

Condition or disease Intervention/treatment Phase
Bacterial Conjunctivitis Drug: Vancomycin 1.1% Drug: Placebo Phase 3

Detailed Description:

Bacterial conjunctivitis is common ocular disease caused by various types of bacteria including methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-resistant Staphylococcus epidermidis (MRSE). External ocular infections such as those caused by MRSA or MRSE frequently are not serious but in rare cases may be severe enough to threaten vision. When ocular infections due to resistant organisms such as MRSA/MRSE do not respond to empiric treatment with approved antibiotics, there are few treatment options. Vancomycin is one of the few treatment options that has been shown to be effective against all clinical isolates of MRSA/MRSE.

This study is a Phase 3 study to evaluate the safety and efficacy of a vancomycin hydrochloride ophthalmic ointment in patients with moderate to severed Gram-positive bacterial conjunctivitis including those with MRSA and MRSE. Subjects, who are adenovirus negative, will be dosed with vancomycin hydrochloride ophthalmic ointment or placebo (vehicle) 4 times daily for 7 days and evaluated for clinical and bacterial resolution of their infection along with an assessment of the safety of the investigational product.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-Masked, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Vancomycin Hydrochloride Ophthalmic Ointment 1.1% in Patients With Moderate to Severe Bacterial Conjunctivitis
Actual Study Start Date : May 2015
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
Experimental: Vancomycin 1.1%
Vancomycin hydrochloride ophthalmic ointment 1.1% dosed approximately 1 cm of ointment QID for 7 days
Drug: Vancomycin 1.1%
Vancomycin hydrochloride ophthalmic ointment 1.1%

Placebo Comparator: Placebo
Vehicle (placebo) ophthalmic ointment dosed approximately 1 cm of ointment QID for 7 days
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Clinical resolution [ Time Frame: 8 days ]
    Between group difference in clinical resolution of bacterial conjunctivitis (defined as absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection) at Day 8


Secondary Outcome Measures :
  1. Microbial eradication [ Time Frame: 8 days ]
    Between-group difference in microbial eradication (absence of all Gram-positive bacterial species present at or above the pathological threshold at baseline) at Day 8

  2. Safety as measured by an evaluation of the incidence of adverse events [ Time Frame: 8 days ]
    Evaluation of the incidence of adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 1 and older
  2. Clinical diagnosis of acute bacterial conjunctivitis with at least one eye exhibiting conjunctival discharge graded ≥ 2 as well as palpebral conjunctival injection graded ≥ 2 AND bulbar conjunctival injection graded ≥ 2 with onset ≤ 4 days as reported by the subject.
  3. Negative test result on AdenoPlus® adenovirus test.
  4. Snellen visual acuity (VA) equal to or better than 20/200 in each eye using current corrective lenses, if required (or if worn) and/or using pinhole if subject's corrective lenses are not available at the time of exam. Every attempt should be made to obtain a VA measurement in children and, if it is unobtainable, the decision as to whether the criterion is met will be at the investigator's discretion.
  5. Female subjects must be 1-year postmenopausal, surgically sterilized, or women of childbearing potential with a negative urine pregnancy test at Visit 1. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include the use of at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.
  6. Able to self-administer study medication or to have the study medication administered by a caregiver throughout the study period.
  7. Must have signed written consent from the subject prior to participation in any study-related procedures if the subject is 18 years of age or older, or from the legally authorized representative/guardian if the subject is under 18 years of age.
  8. Must have the signature of the subject on the assent form, as required by Institutional Review Board (IRB) guidelines, if the subject is under 18 years of age.

Exclusion Criteria:

  1. Suspected viral or allergic conjunctivitis or suspected fungal or acanthamoeba infections at Screening in either eye.
  2. Suspected iritis/uveitis or episcleritis/scleritis at Screening in either eye or history of either condition.
  3. Active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis (eg, confluent epithelial loss or any subepithelial infiltration) in either eye.
  4. History of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome in study eye.
  5. Uncontrolled systemic or debilitating disease (eg, cardiovascular disease, hypertension, diabetes, or cystic fibrosis) in the opinion of the Investigator.
  6. Subjects who are immunocompromised (eg, HIV-positive); any use of immunosuppressive therapy (including chemotherapy).
  7. Any use of topical ophthalmic medications, including tear substitutes, within 2 hours before Screening and throughout the study period in either eye.
  8. Use of topical ophthalmic antimicrobial therapy within 48 hours prior to Screening. Use of topical ophthalmic antimicrobial therapy other than study medication is prohibited throughout the study period in either eye.
  9. Use of topical ophthalmic anti-inflammatory agents (eg, nonsteroidal anti-inflammatory drugs [NSAIDs] or steroids, including steroid-antibiotic combinations) within 48 hours prior to Screening and throughout the study period.
  10. Use of systemic antimicrobial therapy for active respiratory tract, urinary tract, skin/soft tissue, or otitis media infection within 72 hours prior to Screening and throughout the study period. Use of a topical dermatologic antibiotic is permitted.
  11. Use of systemic steroids within 14 days of screening and throughout the study period. Inhaled, intranasal, and topical dermatological steroids are permitted.
  12. Contact lens wear during the study period in study eye. (contact lens wear in an untreated fellow eye is allowed).
  13. Ocular surgery (nonlaser or laser) within 6 weeks prior to Screening in study eye.
  14. Pregnancy or lactation.
  15. Participation in an ophthalmic drug or device research study within 30 days prior to Screening in either eye.
  16. Known hypersensitivity to vancomycin, petrolatum, or mineral oil

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): NCT02432807


Locations
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United States, California
Paramount, California, United States
Petaluma, California, United States
Rancho Cordova, California, United States
United States, Florida
Deerfield Beach, Florida, United States
United States, Iowa
Waterloo, Iowa, United States
United States, Kansas
Newton, Kansas, United States
Pittsburg, Kansas, United States
Shawnee Mission, Kansas, United States
United States, Maryland
Havre De Grace, Maryland, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, North Carolina
Asheville, North Carolina, United States
High Point, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Oregon
Roseburg, Oregon, United States
United States, South Carolina
Spartanburg, South Carolina, United States
United States, Tennessee
Memphis, Tennessee, United States
Sponsors and Collaborators
Kurobe LLC

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Responsible Party: Kurobe LLC
ClinicalTrials.gov Identifier: NCT02432807     History of Changes
Other Study ID Numbers: KUR-1301-101
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Conjunctivitis, Bacterial
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents