SLCTR/2013/026已完成未知
A Multicenter, Randomized Study of the Efficacy and Safety of NVC-422 Ophthalmic Solution for the Treatment of Adenoviral Conjunctivitis
ovaBay Pharmaceutical, Inc0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- •Male or female, of any race, at least 1 year of age
- •At least 1 eye (and in that same eye) must have the following:
- •oBulbar conjunctival injection
- •oPositive adenovirus test using the Adeno Detector Plus™
- •oOnset and development of ocular symptoms and/or signs of conjunctivitis ? 3 days prior to enrollment (Day 1)
- •Note: Subjects that have 1 eye with symptoms > 3 days are eligible as long as the other eye meets the criteria of ? 3 days.
- •Signed and dated IRB/IEC-approved informed consent form. If subject is less than 18 years of age, the informed consent must be signed and dated by subject’s legally authorized representative (parent or guardian). Assent to participate should also be obtained from subjects under 18 years of age if required by local regulation.
- •Agreement to comply with the visit schedule and other requirements of the study.
- •Contact lens wearer must be willing to not wear contacts during study participation, and, if correction is required, have spectacles (eye glasses) with appropriate correction.
- •Females who are not pregnant and are not lactating. All females of childbearing potential may participate only if they have a negative urine pregnancy test prior to randomization, and if they agree to use adequate birth control methods to prevent pregnancy throughout the study.
排除标准
- •Presence of subepithelial infiltrates (SEIs) at the Day 1 visit in either eye.
- •Abnormal, significant corneal opacities at the Day 1 visit in either eye whose appearance or activity might confuse the grading of signs and symptoms due to adenovirus– induced pathology.
- •Only 1 sighted eye or vision in either eye not correctable to 0.6 or better logMAR (using ETDRS chart) at the Day 1 visit.
- •Significant, active, posterior (macular, retinal or choroidal) pathology that requires invasive treatment and might progress during the course of the protocol
- •A suspected bacterial, fungal, herpes, Chlamydia or Acanthamoeba co-infection, based on clinical observation.
- •Active or recent history (within the past 6 months) of uveitis or iritis in either eye.
- •Active or recent history (within the past 6 months) of dry eye requiring treatment, and current moderate to severe burning in either eye.
- •Active seasonal ocular allergies accompanied by current moderate to severe itching in either eye.
- •History of corneal transplant in either eye including any allopathic corneal transplant procedure such as DSEK, DALK, or any variant of these procedures.
- •Presence of nasolacrimal duct obstruction at Day 1 including unilateral or bilateral punctum plugs or permanent punctal occlusion.
- •Use of any topical ocular antiviral agent within 14 days prior to study.
- •Use of any oral or nasal antihistamines at the time of entry into the study.
- •Use of oral corticosteroids within 14 days prior to study entry. Use of topical ocular steroids within 7 days prior to study entry.
- •Use of oral or topical ocular nonsteroidal anti-inflammatories (NSAIDs) the day of study entry (i.e., must have discontinued use the day before enrollment). Acetaminophen PRN is allowed.
- •Unwilling or unable to not use prohibited medications or therapies listed in study protocol during study participation.
- •Any systemic or ocular disease (e.g., atopy, Sjogrens syndrome), disorder, complicating factors, or structural abnormality that would negatively affect the conduct or outcome of the study (e.g., hepatitis, acute or chronic renal insufficiency).
- •Any current immunosuppressive disorder (e.g., HIV-positive), or use of immunosuppressive therapy (including chemotherapy).
- •Participation in any other investigational clinical study within 30 days prior to study enrollment.
- •Subjects that have undergone intraocular or refractive surgery within 6 months prior to study.
- •Subjects with open angle glaucoma or ocular hypertension.
研究者
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