EUCTR2016-003361-25-EE进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 721
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 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:
- •5.1. Report presence of signs and/or symptoms of bacterial conjunctivitis for =4 days prior to Visit 1
- •5.2. Bulbar conjunctival injection: a grade of =1 on 0-4 scale of Bulbar Conjunctival Injection Scale
- •5.3. Ocular conjunctival discharge: a grade of =1 (mild) on a 0-3 scale of Ocular 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: 114
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 535
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 72
排除标准
- •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
- •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 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.
- •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
- •15. Be a known intraocular pressure (IOP) steroid responder, have a
- •known history of glaucoma, be a glaucoma suspect.
- •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
- •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.
研究者
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