Reducing Adenoviral Patient Infected Days
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Percent Change From Peak Viral Load
研究概览
简要总结
The primary aim of this pilot study is to generate data needed to design a definitive trial to compare the safety and efficacy of standard care with artificial tears vs. Betadine 5% (5% povidone-iodine) for the treatment of pink eye due to adenovirus. There is currently no FDA approved treatment for pink eye, a common and highly contagious eye infection caused by adenovirus. Standard care as recommended by the American Academy of Ophthalmology and American Optometric Association is instillation of artificial tears to relieve symptoms and possibly reduce the virus population. Betadine 5% is a commercially available, broad-spectrum antiseptic ophthalmic solution used for over 50 years to prepare the patient's eye and surrounding area for eye surgery. Because Betadine 5% kills bacteria and viruses, it may be useful in treating adenoviral conjunctivitis. Betadine 5% is inexpensive, safe, widely available, and immune to the development of bacterial/viral resistance. Betadine 5% has the potential to significantly impact the clinical management of "pink eye" worldwide.
This pilot study has received funding from the National Eye Institute. Participants who meet eligibility criteria will be randomized using a masked randomization packet to receive one-time, in-office treatment with either artificial tears or Betadine 5%.
Patients who agree to study participation will answer questions about their pink eye symptoms, medical and ocular history, have an eye examination and be tested to confirm "pink eye" due to adenovirus using a FDA approved "point of care" immunoassay. Participants testing positive for adenovirus will have a tear sample taken to measure viral load by qPCR. Randomization and a one-time treatment with either (standard care) artificial tears or Betadine 5% will be done on the first visit. Follow-up visits are at 1,4,7,14 and 21 days. At each visit, symptoms of pink eye are asked, a standardized study eye examination is given by the masked clinician and a sample of tears is taken to assess viral load by qPCR.
详细描述
Aim 1: To compare the safety and efficacy of 5% Betadine to artificial tears in reducing viral load in patients with adenoviral conjunctivitis.
Aim 2: To compare the efficacy of 5% Betadine to artificial tears in reducing patient reported bothersomeness of ocular symptoms.
"Pink eye" (adenovirus conjunctivitis Ad-Cs)is a common ocular condition, with afflicted patients comprising as much as 2% of a general practitioner's practice. Partly due to the ability of adenovirus to remain infectious in the desiccated state for weeks at room temperature, Ad-Cs is more contagious than other forms of conjunctivitis and it can be spread via both ocular or respiratory secretions. Owing to the highly contagious nature of this condition, Ad-Cs outbreaks occur where people congregate: schools, military units, nursing homes, workplaces, community and health-care facilities. With respect to the latter, the nosocomial spread of the condition is a significant public health issue as 17% of 145 cases, 44% of 192 cases and 85% of 132 cases were reported to originate at the place of eye examination. The infection spreads from the first affected eye to the fellow eye in a majority of patients, and secondary transmission of viral conjunctivitis to members of the same household is estimated to occur at a rate of 20%. Outbreaks of Ad-Cs spare no nationality, age, gender or social class and because of the epidemic potential of some adenoviral serotypes, Ad-Cs is a reportable condition in Germany and Japan. A treatment that decreases the duration of the infectious period could have substantial impact in reducing the spread of Ad-Cs outbreaks.
To insure timely completion of recruitment, especially since outbreaks are seasonal and episodic, the study has recruited 6 participating clinical sites nationally. To attain the overall sample target of 50 randomized patients, about 200 pts with pink eye will need to be screened. Each clinic will screen 30-40 patients and randomize 8-10 over a 12 month period.
Patients who present with presumed acute Ad-Cs, who are 19 years of age or older and report symptom onset of 4 days or less in the first affected eye will be invited to undergo eligibility screening.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: Patients will be 18 years and older.
- •Duration of pink eye symptoms: No more than 4 days in first affected eye Positive immunoassay test "AdenoPlus(TM)" for presence of adenovirus.
- •Sex: "Pink eye" {adenoviral conjunctivitis (Ad-Cs)} occurs with equal prevalence in males and females, therefore we will recruit both genders.
- •Race/Ethnicity: Individuals of all races and ethnicities will be invited to participate in this study. Patient recruitment will reflect the distribution of race/ethnicity demographics for the patient population specific to each study site.
排除标准
- •Patients with history of herpes simplex infection or corneal ulceration
- •Eye surgery in the last 3 months
研究组 & 干预措施
Betadine 5%
One time in-office administration (4-5 drops) of Betadine 5% limited to 2 minutes, followed by saline lavage.
干预措施: Betadine 5% (Drug)
Artificial Tears
One time in-office administration (4-5 drops) of artificial tears limited to 2 minutes, followed by saline lavage.
干预措施: Artificial Tears (Drug)
结局指标
主要结局
Percent Change From Peak Viral Load
时间窗: 21 days
To compare efficacy of Betadine 5% to artificial tears to change from peak viral load in Adenoviral conjunctivitis
次要结局
- Participant Reported Bothersomeness of Ocular Symptoms(21 days)