CTRI/2023/01/048896已完成2 期
A Double-Masked, Placebo-Controlled, Randomized,Phase II Clinical Trial ToAssess The Efficacy Of IVIEW-1201 In The Treatment Of Acute Adenoviral ConjunctivitisClinical Efficacy and Safety of IVIEW-1201 (1.0% PVP-Iodine) Gel FormingOphthalmic Solution Compared to Placebo in the Treatment of AdenoviralConjunctivitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
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.
- •2 Ability to voluntarily provide written, signed, and dated consent/assent to participate in the
- •3 Subjects of age 15 and over at Visit 1.
- •4 Have a positive QuickVue Adenoviral conjunctivitis 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:
- •a. Report presence of signs and/or symptoms of adenoviral conjunctivitis for equal to or less than 3 days prior to Visit 1
- •b. Bulbar conjunctival injection: a grade of equal to or more than 1 on 0-4 scale of Bulbar Conjunctival Injection Scale
- •c. Watery conjunctival discharge: a grade of equal to or more than 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 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
- •1 Current or recurrent disease that could affect the action, absorption, or disposition of the
- •investigational product, or clinical or laboratory assessments, per investigators 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 IVIEW-1201 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 blepharoconjunctivitis), other than adenoviral
- •conjunctivitis.
- •9. Have presence of corneal subepithelial infiltrates at Visit 1
- •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-adenoviral ocular infection
- •(eg, bacterial, fungal, acantamoeba, other or parasitic).
- •11. Age under 15.
- •12. Prisoner.
- •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. 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.
- •18. Have used any topical ocular or systemic anti-virals or antibiotics within less than or equal 7
- •days of enrollment.
- •19. Have used any topical ocular NSAIDs within less than or equal 1 day of enrollment.
- •20. Have used any topical ophthalmic steroids in the last less than or equal to 14 days.
- •21. Have used any systemic corticosteroid agents within less than or equal to 14 days of Day 1. Stable (initiated less than or equal to 30 days prior to enrollment) use of inhaled and nasal corticosteroids is allowed, given no
- •anticipated change in dose for the duration of the study. Topical dermal steroids are allowed
- •except in the peri-ocular area.
- •22. Have used non-corticosteroid immunosuppressive agents within less than or equal to 14 days of Day 1, oral or topical or both.
- •23. Have used any topical ophthalmic products, including tear substitutes, and over-thecounter
- •preparations
研究者
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