Reducing Adenoviral Patient Infected Days
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/4/2018 |
| Start Date: | March 2015 |
| End Date: | January 31, 2019 |
| Contact: | Mae O Gordon, PhD |
| Email: | gordon.mae@wustl.edu |
| Phone: | (314) 362-3716 |
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.
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.
Aim 1: To determine specificity of AdenoPlus(TM) "point of care" immunoassay strips perform
in diagnosing the presence of adenovirus compared to qPCR testing.
Aim 2: To determine what percentage of participants will stay in the study for 21 days, the
rate of reduction in clinical signs, patient reported symptoms and adenovirus measured by
qPCR.
Aim 3: To examine the relationship between the amount of adenovirus measured in tears by
qPCR, clinical signs and patient-reported 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.
Over a 12 month recruitment period, 6 Clinical Centers will screen at least 200 patients who
present with presumed Ad-Cs, to enroll 50 eligible patients. Of the 6 Clinics, 4 are in
Optometry departments - Illinois College of Optometry, Ohio State University, Northeastern
State University and University of Alabama at Birmingham and 2 Clinics are in Ophthalmology
departments- University of Illinois and Washington University School of Medicine. These
clinics provide geographic diversity and multi-ethnic representation (including African
American, Asian, Caucasian, Hispanic and Native American groups). Because patients with pink
eye are more likely to see an optometrist than an ophthalmologist, PI's of Clinics are
optometrists.
Patients who consent to participation:
- Participant completes eligibility screening about 30 minutes - confirmation of age and
symptom duration, a symptom survey, an eye examination;
- AdenoPlus(TM) test to confirm adenoviral conjunctivitis (Screening/Baseline Form);
- Participants who test positive by AdenoPlus(TM) are "fully eligible" and a tear sample
will be taken for qPCR testing.
Fully eligible participants
- Will be randomized using masked packets identified by serial numbers containing the
randomized treatment with either artificial tears or Betadine 5%;
- "Treating" unmasked study certified clinician will administer treatment as randomized;
- Participants will rate the discomfort of treatment to assess treatment tolerability and
asked to guess whether they received artificial tears or Betadine 5%.
Follow-up visits will be scheduled for 1, 4, 7, 14 and 21 days after treatment. Each
follow-up visit is about 30 minutes.
- Participants will rate the discomfort of treatment to assess treatment tolerability on
day 1 post treatment;
- Masked clinician/technician will ask the 10-question pink eye ocular symptom
questionnaire;
- Masked clinician will perform the eye examination;
- Masked clinician/technician will take conjunctival tear sample for analysis of viral
load by qPCR.
- Participants who miss f/up visits will be asked to complete the symptom checklist by
telephone or by secure REDCap data entry.
All study-related encounters with potential study participants will be conducted in private,
closed-door, "Red Eye" examination room in the clinical center. All study certified personnel
will ensure patient confidentiality at all times. The minimum amount of information needed
for the study will be collected from study participants. All research study data are coded as
to clinic site and patient ID and do not include personal health data. Personal health data
are kept physically separate from research study data. All data are kept in HIPAA compliant
office spaces. All study data will be collected and maintained using a secure, password
protected web-based data capture program (REDCap).
The study drug, Betadine 5% is FDA approved for topical ocular surface application to the
cornea, conjunctiva and palpebral fornices and is used in this study at the recommended dose,
age group, duration and method of application. Risk is minimized by limiting administration
to a single, one-time, in-office application. A study certified optometrist/technician
instills artificial tears or Betadine 5% in the study eye. If there are immediate untoward
reactions, the patient is in a fully equipped and staffed eye care facility where appropriate
expertise and treatment are available. Participants are closely monitored with follow-up eye
examinations at 1, 4, 7, 14 and 21 days after treatment.
Potential nosocomial infections are minimized by asking the patient to use hand sanitizer
before entering the examination room. Patient signs only the consent form and all other
surveys are administered by the clinician/technician. We will observe strict adherence to
current CDC disinfection protocol for Ad-Cs. Patients reporting marked symptoms will be
withdrawn from the study and managed according to standard clinical care guidelines.
in diagnosing the presence of adenovirus compared to qPCR testing.
Aim 2: To determine what percentage of participants will stay in the study for 21 days, the
rate of reduction in clinical signs, patient reported symptoms and adenovirus measured by
qPCR.
Aim 3: To examine the relationship between the amount of adenovirus measured in tears by
qPCR, clinical signs and patient-reported 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.
Over a 12 month recruitment period, 6 Clinical Centers will screen at least 200 patients who
present with presumed Ad-Cs, to enroll 50 eligible patients. Of the 6 Clinics, 4 are in
Optometry departments - Illinois College of Optometry, Ohio State University, Northeastern
State University and University of Alabama at Birmingham and 2 Clinics are in Ophthalmology
departments- University of Illinois and Washington University School of Medicine. These
clinics provide geographic diversity and multi-ethnic representation (including African
American, Asian, Caucasian, Hispanic and Native American groups). Because patients with pink
eye are more likely to see an optometrist than an ophthalmologist, PI's of Clinics are
optometrists.
Patients who consent to participation:
- Participant completes eligibility screening about 30 minutes - confirmation of age and
symptom duration, a symptom survey, an eye examination;
- AdenoPlus(TM) test to confirm adenoviral conjunctivitis (Screening/Baseline Form);
- Participants who test positive by AdenoPlus(TM) are "fully eligible" and a tear sample
will be taken for qPCR testing.
Fully eligible participants
- Will be randomized using masked packets identified by serial numbers containing the
randomized treatment with either artificial tears or Betadine 5%;
- "Treating" unmasked study certified clinician will administer treatment as randomized;
- Participants will rate the discomfort of treatment to assess treatment tolerability and
asked to guess whether they received artificial tears or Betadine 5%.
Follow-up visits will be scheduled for 1, 4, 7, 14 and 21 days after treatment. Each
follow-up visit is about 30 minutes.
- Participants will rate the discomfort of treatment to assess treatment tolerability on
day 1 post treatment;
- Masked clinician/technician will ask the 10-question pink eye ocular symptom
questionnaire;
- Masked clinician will perform the eye examination;
- Masked clinician/technician will take conjunctival tear sample for analysis of viral
load by qPCR.
- Participants who miss f/up visits will be asked to complete the symptom checklist by
telephone or by secure REDCap data entry.
All study-related encounters with potential study participants will be conducted in private,
closed-door, "Red Eye" examination room in the clinical center. All study certified personnel
will ensure patient confidentiality at all times. The minimum amount of information needed
for the study will be collected from study participants. All research study data are coded as
to clinic site and patient ID and do not include personal health data. Personal health data
are kept physically separate from research study data. All data are kept in HIPAA compliant
office spaces. All study data will be collected and maintained using a secure, password
protected web-based data capture program (REDCap).
The study drug, Betadine 5% is FDA approved for topical ocular surface application to the
cornea, conjunctiva and palpebral fornices and is used in this study at the recommended dose,
age group, duration and method of application. Risk is minimized by limiting administration
to a single, one-time, in-office application. A study certified optometrist/technician
instills artificial tears or Betadine 5% in the study eye. If there are immediate untoward
reactions, the patient is in a fully equipped and staffed eye care facility where appropriate
expertise and treatment are available. Participants are closely monitored with follow-up eye
examinations at 1, 4, 7, 14 and 21 days after treatment.
Potential nosocomial infections are minimized by asking the patient to use hand sanitizer
before entering the examination room. Patient signs only the consent form and all other
surveys are administered by the clinician/technician. We will observe strict adherence to
current CDC disinfection protocol for Ad-Cs. Patients reporting marked symptoms will be
withdrawn from the study and managed according to standard clinical care guidelines.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with history of herpes simplex infection or corneal ulceration
- Eye surgery in the last 3 months
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