EUCTR2016-003361-25-HU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 =3 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 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.
研究者
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