A Phase 3, Multi-center, Randomized, Double-Masked Study to Evaluate the Clinical Efficacy and Safety of SHP640 (PVP-Iodine 0.6% and Dexamethasone 0.1%) Ophthalmic Suspension Compared to Placebo in the Treatment of Bacterial Conjunctivitis
Principal Investigator: Sarah Nehls, MD
Study Coordinator: Chris Smith
Study Drug: SHP640
Total Subjects: Approximately 721 with 3 different treatment arms
Study Participation: Will last up to 13 days
Objective: The primary objective of this study is to evaluate the efficacy of SHP640 based on clinical resolution (defined as absence of bulbar conjunctival injection and ocular conjunctival discharge) compared with placebo in the treatment of subjects with bacterial conjunctivitis in the study eye at Visit 3 (Day 5).
The subject will not be considered eligible for the study without meeting all of the criteria below:
1. An understanding, ability, and willingness to fully comply with study procedures and restrictions (by the parent(s), guardian, or legally authorized representative, if applicable).
2. 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.
3. Subjects of any age at Visit 1 (Note: subjects <3 months of age at Visit 1 must have been full-term, ie ≥37 weeks gestational age at birth).
4. Have a negative AdenoPlus® test in both eyes within 24 hours of Visit 1 or at Visit 1.
5. 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:
Report presence of signs and/or symptoms of bacterial conjunctivitis for ≤3 days prior to Visit 1
Bulbar conjunctival injection: a grade of ≥1 on 0-4 scale of Bulbar Conjunctival Injection Scale
Ocular conjunctival discharge: a grade of ≥1 (mild) on a 0-3 scale of Ocular Conjunctival Discharge Scale
Shire CONFIDENTIAL Page 14
SHP640-303 Protocol Amendment 2
SHP640 (FST-100) 15 Feb 2017
6. Be willing to discontinue contact lens wear for the duration of the study.
7. 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 subjects <2 months of age who have not yet developed this ability. Subjects <2 months will be enrolled at the discretion of investigator.
8. 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.
For more information, contact Chris Smith at 608-263-7169