CTRI/2019/04/018758Other3 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 Adenoviral Conjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 165
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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), unless otherwise indicated due to local requirements; in India subjects must be >12 years of age.
- •4. Meet at least 1 of the 2 criteria below:
- •a.Have a positive AdenoPlus® test at Visit 1 in at least 1 eye.
- •b.Have at least 2 of the following 5 criteria, based upon medical history and examination:
- •i.Symptoms within the past 7 days consistent with acute upper respiratory tract infection (eg, sore throat, cough, rhinorrhea, etc)
- •ii.Contact within the past 7 days with family members or other individuals with recent onset of symptoms consistent with conjunctivitis
- •iii.Acute onset within the past 4 days of one or more of the following ocular symptoms: burning/irritation, foreign body sensation, light sensitivity
- •iv.Enlarged periauricular lymph node(s)
- •v.Presence of follicles on tarsal conjunctiva
- •Note: If the subject only meets Inclusion Criterion 4a (a positive AdenoPlus test in at least 1 eye), then the same eye must meet Inclusion Criterion 5.
- •5. Have a clinical diagnosis of suspected adenoviral 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 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.
- •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
排除标准
- •Subjects are excluded from the study if any of the following exclusion criteria are met.
- •1. Current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments, per investigatorâ??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. Prior enrollment in a FST-100 or SHP640 clinical study.
- •5. Subjects who are employees, or immediate family members of employees (who are directly related to study conduct), at the investigational site.
- •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 blepharon conjunctivitis), other than adenoviral conjunctivitis.
- •9. Have presence of corneal subepithelial infiltrates at Visit 1
- •10. Have active or history of ocular herpes.
- •11. 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.
- •12. 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.
- •13. 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.
- •14. Presence of nasolacrimal duct obstruction at Visit 1 (Day 1).
- •15. 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.
- •16. Be a known intraocular pressure (IOP) steroid responder, have a known history or current diagnosis of glaucoma, be a glaucoma suspect.
- •17. Have any known clinically significant optic nerve defects.
- •18. 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.
- •19. 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.
- •20. Have used any topical ocular or systemic anti-virals or antibiotics within <= 7 days of enrollment.
- •21. Have used any topical ocular NSAIDs within <=1 da
研究者
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