Bacterial Conjunctivitis MedDRA version: 20.0 Level: PT Classification code 10061784 Term: Conjunctivitis bacterial System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: SHP640
Product Code: SHP640
Pharmaceutical Form: Eye drops
INN or Proposed INN: Dexamethasone
CAS Number: 50 - 02 - 2
Current Sponsor code: SRD006094
Other descriptive name: DEXAMETHASON
Sponsors
Shire Human Genetic Therapies, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main Inclusion Criteria: 3. Subjects of any age at Visit 1 (Note: subjects =65 years) yes F.1.3.1 Number of subjects for this age range 72
Exclusion criteria
Exclusion criteria: Main Exclusion Criteria: 1. 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. 2. Current or relevant history of physical or psychiatric illness, any medical disorder that may make the subject unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures. 3. Have known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients. 6. Have a history of ocular surgical intervention within =6 months prior to Visit 1 or planned for the period of the study. 7. Have a preplanned overnight hospitalization during the period of the study. 8. Have presence of any intraocular, corneal, or conjunctival ocular inflammation (eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than bacterial conjunctivitis. 9. Have active or a history of ocular herpes. 10. Have at enrollment or within =30 days of Visit 1, a clinical presentation more consistent with the diagnosis of ocular allergy, toxic conjunctivitis, or non-bacterial ocular infection (eg, viral, fungal, acanthamoebal, other parasitic). 11. Neonates or infants (ie. subjects 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. 12. Neonates or infants (ie. subjects 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. 13. Presence of nasolacrimal duct obstruction at Visit 1 (Day 1). 14. 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. 15. Be a known intraocular pressure (IOP) steroid responder, have a known history of glaucoma, be a glaucoma suspect, or have a known history of an elevated IOP >21 mmHg 16. Have any known clinically significant optic nerve defects. 17. 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. 18. 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. Full list of Exclusion criteria can be found in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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).;Secondary Objective: The key secondary objective of this study is to evaluate the efficacy of SHP640 based on bacterial eradication (defined as absence of all bacterial species present at or above pathological threshold at baseline) compared with placebo in the treatment of subjects with bacterial conjunctivitis in the study eye at Visit 3 (Day 5).;Primary end point(s): Clinical resolution status (defined as absence of bulbar conjunctival injection and ocular conjunctival discharge) in the study eye at Visit 3 (Day 5) between SHP640 and placebo.;Timepoint(s) of evaluation of this end point: Visit 3 (Day 5) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Efficacy Endpoints: 1.Bacterial eradication status (defined as absence of all bacterial species present at or above pathological threshold at baseline) in the study eye at Visit 3 (Day 5) between SHP640 and placebo. Secondary Efficacy Endpoints: 2. Clinical resolution status of bacterial conjunctivitis at Visits 2 (Day 3), 4 (Day 8), and 5 (Day 12) in the study eye 3. Bacterial eradication status (defined as absence of all bacterial species present at or above pathological threshold at baseline) as assessed by bacterial culture at Visits 2 (Day 3), 4 (Day 8), and 5 (Day 12) in the study eye 4. Absolute and change from baseline of the individual clinical signs (bulbar conjunctival injection and ocular conjunctival discharge) at Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12) in the study eye 5.The global clinical score (defined as the sum of bulbar conjunctival injection and ocular conjunctival discharge) and change from baseline in the global clinical score at Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12) in the study eye 6. Modified clinical resolution status, defined as a global clinical score of 0 or 1, at Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12) in the study eye 7. Expanded clinical resolution status, defined as a global clinical score of 0, 1, or 2 with neither injection nor discharge having a score of 2, at Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12) in the study eye 8. Time to clinical resolution based upon assessments at Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day 12) in the study eye 9. Use of rescue medication Safety Endpoints: - BCVA - Slit lamp biomicroscopy - Non-dilated/dilated fundus examination - Urine pregnancy testing - Adverse events ;Timepoint(s) of evaluation of this end point: 1.Visit 3 (Day 5) 2. Visits 2 (Day 3), 4 (Day 8), and 5 (Day 12) 3. Visits 2 (Day 3), 4 (Day 8), and 5 (Day 12) 4. Visits 2 (Day 3), 3 (Day 5), 4 (Day 8), and 5 (Day | — |
Countries
Australia, Austria, Canada, Colombia, Estonia, France, Germany, Hungary, India, Israel, Italy, Peru, Philippines, Poland, South Africa, Spain, United Kingdom, United States
Contacts
Public ContactStudy Manager
Shire Human Genetic Therapies, Inc.
Outcome results
None listed