EUCTR2016-002439-14-PLActive, not recruitingPhase 1
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 PVP-Iodine and Placebo in the Treatment of Adenoviral Conjunctivitis
Shire Human Genetic Therapies, Inc.0 sites219 target enrollmentStarted: September 18, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 219
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Main Inclusion Criteria:
- •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 positive AdenoPlus® test at Visit 1 in at least 1 eye.
- •5. Have a clinical diagnosis of suspected adenoviral conjunctivitis in at least 1 eye (the same eye as the AdenoPlus positive 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 adenoviral conjunctivitis for = 4 days prior to Visit 1
- •- Bulbar conjunctival injection: a grade of =1 (mild) on a 0-4 Bulbar Conjunctival Injection Scale.
- •- Watery conjunctival discharge: a grade of =1 (mild) on a 0-3 Watery Conjunctival Discharge Scale
- •6. Be willing to discontinue contact lens wear for the duration of the study.
- •Full list of Inclusion criteria can be found in the protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 143
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 694
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 93
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.
- •4. Have a history of ocular surgical intervention within =6 months prior to Visit 1 or planned for the period of the study.
- •5. Have a preplanned overnight hospitalization during the period of the study.
- •6. Have presence of any intraocular, corneal, or conjunctival ocular inflammation (eg, uveitis, iritis, ulcerative keratitis, chronic blepharoconjunctivitis), other than adenoviral conjunctivitis.
- •7. Have presence of corneal subepithelial infiltrates at Visit 1.
- •8. Have active or history of ocular herpes.
- •9. 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-adenoviral ocular infection (eg, bacterial, fungal, acanthamoebal, or other parasitic). Note: history or concomitant presence of presumed seasonal or perennial allergic conjunctivitis signs/symptoms is not exclusionary.
- •10. 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.
- •11. 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.
- •12. Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).
- •13. 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.
- •14. Be a known intraocular pressure (IOP) steroid responder, have a known history of glaucoma, be a glaucoma suspect.
- •15. Have any known clinically significant optic nerve defects.
- •16. 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.
- •17. Presence of significant, active condition in the posterior segment which requires invasive treatment (eg, intravitreal treatment with VEGF inhibitors or corticosteroids) and may progress during the study participation period.
- •Full list of Exclusion criteria can be found in the protocol.
Investigators
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