Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo
Condition: Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Intervention: SHP640; PVP-I 0.6%; Placebo
Intervention description: Instill 1 drop of SHP640 (povidone-iodine [PVPI] 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.; Instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.; Instill 1 drop of placebo ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 753.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if an investigational treatment is effective
      compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial
      conjunctivitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An understanding, ability, and willingness to fully comply with study procedures and
             restrictions (by the parent(s), guardian, or legally authorized representative, if
             applicable).

          -  Ability to voluntarily provide written, signed, and dated (personally or via a
             parent(s), guardian, or legally authorized representative(s) informed consent (and
             assent, if applicable) to participate in the study.

          -  Participants of any age at Visit 1 (Note: participants less than (<) 3 months of age
             at Visit 1 must have been full-term, that is (ie,) greater than or equal to (>=) 37
             weeks gestational age at birth).

          -  Have a negative AdenoPlus® test in both eyes within 24 hours of Visit 1 or at Visit 1.

          -  Have a clinical diagnosis of suspected bacterial conjunctivitis in at least 1 eye
             confirmed by the presence of the following minimal clinical signs and symptoms in that
             same eye:

               1. Report presence of signs and/or symptoms of bacterial conjunctivitis for less
                  than or equal to (<=) 4 days prior to Visit 1

               2. Bulbar conjunctival injection: a grade of >= 1 on 0-4 scale of Bulbar
                  Conjunctival Injection Scale

               3. Ocular conjunctival discharge: a grade of >= 1 (mild) on a 0-3 scale of Ocular
                  Conjunctival Discharge Scale

          -  Be willing to discontinue contact lens wear for the duration of the study.

          -  Have a Best Corrected Visual Acuity (BCVA) of 0.60 logMAR or better in each eye as
             measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. BCVA will
             be assessed by an age appropriate method in accordance with the AAP Policy Statement
             for Visual System Assessment in Infants, Children, and Young Adults by Pediatricians
             (Donahue and Baker, 2016; American Academy of Pediatrics, 2016). The policy statement
             recommends formal vision screening can begin at 3 years of age. VA measurements for
             children under the age of 3 will be done at the discretion of the investigator. If not
             done, child should be able to fixate on and follow a moving object, except
             participants < 2 months of age who have not yet developed this ability. Participants <
             2 months will be enrolled at the discretion of investigator.

          -  Male, or non-pregnant, non-lactating female who agrees to comply with any applicable
             contraceptive requirements of the protocol or females of non-childbearing potential.

        Exclusion Criteria:

          -  Current or recurrent disease that could affect the action, absorption, or disposition
             of the investigational product, or clinical or laboratory assessments, per
             investigator's discretion.

          -  Current or relevant history of physical or psychiatric illness, any medical disorder
             that may make the participant unlikely to fully complete the study, or any condition
             that presents undue risk from the investigational product or procedures.

          -  Have known or suspected intolerance or hypersensitivity to the investigational
             product, closely related compounds, or any of the stated ingredients.

          -  Prior enrollment in a FST-100 or SHP640 clinical study.

          -  Participants who are employees, or immediate family members of employees (who are
             directly related to study conduct), at the investigational site.

          -  Have a history of ocular surgical intervention within <= 6 months prior to Visit 1 or
             planned for the period of the study.

          -  Have a preplanned overnight hospitalization during the period of the study.

          -  Have presence of any intraocular, corneal, or conjunctival ocular inflammation
             (example [eg,] uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis),
             other than bacterial conjunctivitis.

          -  Have active or a history of ocular herpes.

          -  Have at enrollment or within <= 30 days of Visit 1, a clinical presentation more
             consistent with the diagnosis of non-infectious conjunctivitis (except presumed
             seasonal/perennial allergic conjunctivitis) or non-bacterial ocular infection (eg,
             viral, fungal, acanthamoebal, or other parasitic). Note: history or concomitant
             presence of presumed seasonal or perennial allergic conjunctivitis signs/symptoms is
             not exclusionary.

          -  Neonates or infants (ie, participants less than 12 months of age) who have suspected
             or confirmed (based on the result of any test conducted prior to screening)
             conjunctivitis of gonococcal, chlamydial, herpetic or chemical origin.

          -  Neonates or infants (ie, participants less than 12 months of age) whose birth mothers
             had any sexually transmitted disease within 1 month of delivery or any history of
             genital herpes.

          -  Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).

          -  Presence of any significant ophthalmic condition (eg, Retinopathy of Prematurity,
             congenital cataract, congenital glaucoma) or other congenital disorder with ophthalmic
             involvement that could affect study variables.

          -  Be a known intraocular pressure (IOP) steroid responder, have a known history or
             current diagnosis of glaucoma or be a glaucoma suspect.

          -  Have any known clinically significant optic nerve defects.

          -  Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary
             to previous corneal trauma or dry eye syndrome; presence of corneal epithelial defect
             or any significant corneal opacity at Visit 1.

          -  Presence of significant, active condition in the posterior segment that requires
             invasive treatment (eg, intravitreal treatment with vascular endothelial growth factor
             inhibitors or corticosteroids) and may progress during the study participation period.

          -  Have used any topical ocular or systemic antibiotics within <= 7 days of enrollment.

          -  Have used any topical ocular non-steroidal anti-inflammatory drugs within <= 1 day of
             enrollment.

          -  Have used any topical ophthalmic steroids in the last <= 14 days.

          -  Have used any systemic corticosteroid agents within <= 14 days of Day 1. Stable
             (initiated >= 30 days prior to enrollment) use of inhaled and nasal corticosteroids is
             allowed, given no anticipated change in dose for the duration of the study. Topical
             dermal steroids are allowed except in the periocular area.

          -  Have used non-corticosteroid immunosuppressive agents within <= 14 days of Day 1.

          -  Have used any topical ophthalmic products, including tear substitutes, and
             over-the-counter preparations such as lid scrubs, within 2 hours of Visit 1 and be
             unable to discontinue all topical ophthalmic products for the duration of the study.
             Use of hot or cold compresses is also not permitted during the study.

          -  Have any significant ocular disease (eg, Sjogren's syndrome) or any uncontrolled
             systemic disease or debilitating disease (eg, cardiovascular disease, hypertension,
             sexually transmitted diseases/infections, diabetes, or cystic fibrosis) that may
             affect the study parameters, per investigator's discretion.

          -  Any known history of immunodeficiency disorder or known active conditions predisposing
             to immunodeficiency, such as human immunodeficiency virus, hepatitis B or C, evidence
             of active hepatitis A (anti-hepatitis A virus immunoglobulin M), or organ or bone
             marrow transplantation.

          -  Within 30 days prior to the first dose of investigational product:

               1. Have used an investigational product or device, or

               2. Have been enrolled in a clinical study (including vaccine studies) that, in the
                  investigator's opinion, may impact this Shire-sponsored study.