A Prospective, Double-masked, Placebo Controlled Comparison of Topical 0.15% Ganciclovir Gel (Zirgan®) Versus 0.3% Hypromellose Gel (Genteal Gel®; Placebo) for the Treatment of Adenovirus Conjunctivitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Time to Viral Eradication
研究概览
简要总结
The investigators are conducting this study because the patient have an eye infection which is called adenoviral conjunctivitis, and is the most common cause of "pink eye". There is currently no treatment for this condition. However, the researchers associated with this study want to understand if using a product called Zirgan, which is a topical ointment that is already FDA-approved for other types of eye infections, will help with the type of infection that the patient currently have. Zirgan is not FDA-approved to treat your type of eye infection. Your participation in this study is expected to last 21 days but the patient will only apply the topical ointment for 14 of those days. During the study, the patient will be asked to come into this clinic 8 times.
The purpose of this study is to determine whether topical Zirgan can reduce days that the patient suffers from the eye infection, and also to see if it can prevent the infection from spreading to your second eye and to also see if it can prevent the spreading of the infection to people that the patient come in close contact with.
Zirgan will be compared to Genteal Gel in this trial. Genteal Gel is a non-prescription eye lubricant gel and is commonly used for treatment of dry eye.
The patient will be asked to apply a topical ointment (either Zirgan or Genteal gel 5 times a day for the first 7 days and then 3 times a day for the following 7 days. The patient will be asked to return to the clinic 21 days after the patient starts the study for a final check-up.
It is planned that about 80 people with Adenovirus Conjunctivitis will be enrolled in this study between 8-12 sites across the United States.
The patient will be assigned to either Zirgan or Genteal gel by chance which is similar to flipping a coin.
The study groups will be assigned in a 1:1 ratio. Neither the patient nor the study doctor or study staff will be able to pick which study group The patient is in. The patient will not know and the study doctor or study staff will not know which study group the patient is in. The study doctor or study staff can find out if it is necessary to know for your health. If this happens, the study doctor or study staff may not be able to tell the patient which study group the patient was in until everyone finishes the study.
详细描述
Study Objectives To evaluate the safety and efficacy of 0.15% ganciclovir gel (Zirgan®) in patients with adenoviral keratoconjunctivitis in comparison with 0.3% hypromellose gel (Genteal gel®) as placebo.
Background Adenoviruses are the most common cause of ocular viral infection worldwide. Conjunctivitis and keratoconjunctivitis caused by adenoviruses are highly contagious. Adenovirus is a non-enveloped, double-stranded DNA virus comprised of 53 serotypes. Unlike many enveloped viruses which can be more easily inactivated, adenoviruses are resilient to disinfection and are long lasting on fomites. The ocular infection generally begins unilaterally and, in many cases, spreads to both eyes. It may cause epidemics and endemics, being most commonly spread in the summer or winter. Epidemics are common in day care centers, schools and the military and have been spread in the offices of eye care professionals. Patients may have painful conjunctival membranes and palpable preauricular adenopathy. Subsequent subepithelial corneal infiltrates can cause light sensitivity, reduced vision and lead to irregular astigmatism. The differential diagnosis includes herpes simplex, Chlamydia and enteroviral infection.
There are 3 major presentations of ocular adenovirus infection: Follicular conjunctivitis (predominantly serotypes 3, 4,7a); epidemic keratoconjunctivitis (EKC; predominantly serotypes 8, 19, 37, 53); and pharyngealconjunctival fever (mostly serotypes 3, 4, 7a, 11).
There is supporting laboratory and clinical data to warrant a clinical trial of topical ganciclovir for the treatment of adenoviral keratoconjunctivitis. Several studies has shown that ganciclovir (GCV) is active in vitro against adenovirus.
Primary Outcome The primary outcome of the study is to determine whether topical 0.15% ganciclovir (Zirgan®) gel alone will reduce the duration of viral shedding from the ocular surface, as determined by quantitative viral isolation in A549 cell tissue culture, compared to placebo 0.3% hypromellose gel (Genteal gel®).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must be 14 years of age or older. Patients under age 18 will require parental consent for entry.
- •Give written informed consent and use or release of health and research study information.
- •Patients must be able and willing to comply with all treatment and follow-up/study procedures.
- •Patients must have a follicular conjunctivitis and present within 3 days of the onset of symptoms in the first eye.
- •Patients must agree not to wear contact lenses for 14 days while taking study medications.
排除标准
- •Severe dry eye or Sjögren's Syndrome.
- •Corneal graft in either eye.
- •Participation in an investigational study within the past 30 days.
- •Inability to understand instructions or comply with the study visit schedule.
- •Uniocular vision status.
- •Best corrected visual acuity worse than 20/200 in either eye.
- •Uveitis or iritis which requires treatment with corticosteroids.
- •Mucopurulent discharge.
- •Signs of any other viral, fungal, bacterial infection.
- •Congenital, acquired, or iatrogenic immune deficiency.
- •Treatment with systemic or topical ocular antiviral agents or systemic or topical steroids or topical ocular NSAIDS during the prior 14-day period.
- •Presence of subepithelial infiltrates.
- •Bilateral eye involvement with a bulbar conjunctival score of moderate or severe in both the eyes. (Grade 3 or 4 as scored using Efron scale of the bulbar hyperemia component of conjunctivitis).
- •Pregnancy test positive for women of child bearing age or women breastfeeding children or women not practicing accepted method(s) of contraception.
- •Active allergic conjunctivitis
- •History of atopic disease.
- •Known hypersensitivity or allergy to ganciclovir or to BAK or to any of the ingredients in the study drugs
- •Acute eye trauma.
- •Contact lens only with no spectacles available.
- •Expected to require concurrent ocular therapy with immunosuppressants (e.g., Restasis) during the study or have used ocular immunosuppressants within 30 days prior to study start.
- •Ocular surgery (including laser surgery) in either eye within six weeks prior to entry into this study.
研究组 & 干预措施
Zirgan, Adenovirus conjunctivitis,
Zirgan
干预措施: Zirgan (Drug)
genteal gel
0.3% Hypromellose gel (genteal gel)
干预措施: genteal gel (Drug)
结局指标
主要结局
Time to Viral Eradication
时间窗: 14 days
Time to viral eradication from the ocular surface, as determined by quantitative viral isolation in A549 cell tissue culture (performed on Day 0, 2, 4, 6, 8, 10, and 14)
次要结局
- Development of sub-epithelial infiltrates(21 days)
- Degree of Bulbar conjunctival Injection(21 days)
- Second eye involvment(14 days)