Safety and Efficacy of Vancomycin Ophthalmic Ointment in Patients With Moderate to Severe Bacteri… (NCT02432807) | Clinical Trial Compass
CompletedPhase 3
Safety and Efficacy of Vancomycin Ophthalmic Ointment in Patients With Moderate to Severe Bacterial Conjunctivitis
United States303 participantsStarted 2015-05
Plain-language 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.
Who can participate
Age range
1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 1 and older
. 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.
. Negative test result on AdenoPlus® adenovirus test.
. 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.
. 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.
. Able to self-administer study medication or to have the study medication administered by a caregiver throughout the study period.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Subjects With Clinical Resolution of Bacterial Conjunctivitis
. 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
. Suspected viral or allergic conjunctivitis or suspected fungal or acanthamoeba infections at Screening in either eye.
. Suspected iritis/uveitis or episcleritis/scleritis at Screening in either eye or history of either condition.
. Active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis (eg, confluent epithelial loss or any subepithelial infiltration) in either eye.
. History of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome in study eye.
. Uncontrolled systemic or debilitating disease (eg, cardiovascular disease, hypertension, diabetes, or cystic fibrosis) in the opinion of the Investigator.
. Subjects who are immunocompromised (eg, HIV-positive); any use of immunosuppressive therapy (including chemotherapy).
. Any use of topical ophthalmic medications, including tear substitutes, within 2 hours before Screening and throughout the study period in either eye.
. 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.