A Placebo Controlled Comparison of Topical Zirgan Versus Genteal Gel for the Treatment of Adenovirus Conjunctivitis
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.
Keratoconjunctivitis Due to Adenovirus
Drug: genteal gel
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Time to Viral Eradication [ Time Frame: 14 days ] [ Designated as safety issue: No ]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)
- Development of sub-epithelial infiltrates [ Time Frame: 21 days ] [ Designated as safety issue: No ]Development of sub-epithelial infiltrates (SEIs)-incidence for the study duration and severity at each follow-up visit (based on scale of mild, moderate and severe) in those eyes which develop SEIs
- Degree of Bulbar conjunctival Injection [ Time Frame: 21 days ] [ Designated as safety issue: No ]Degree of bulbar conjunctival injection (redness of the eye) (as determined by the Efron scale) at each follow-up visit
- Second eye involvment [ Time Frame: 14 days ] [ Designated as safety issue: No ]Second eye involvement - incidence for the study duration and severity at each visit up to Day 14(measured as degree of bulbar injection using Efron scale) in the baseline culture negative fellow eyes, which turned culture positive during the study up to Day 14
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Zirgan, Adenovirus conjunctivitis,
0.15% ganciclovir gel(Zirgan)
Other Name: Virgan
Placebo Comparator: genteal gel
0.3% Hypromellose gel (genteal gel)
Drug: genteal gel
0.3% Hypromellose gel
Other Name: genteal
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533480
|Contact: Jennifer Greene, BSc.||email@example.com|
|Contact: Jay S Pepose, MD, PhDfirstname.lastname@example.org|
|United States, Missouri|
|Lifelong Vision Foundation||Recruiting|
|Chesterfield, Missouri, United States, 63017|
|Contact: Jennifer Greene, BSc. 636-534-5126 email@example.com|
|Contact: Jay S Pepose, MD, PhD 636-728-0111 firstname.lastname@example.org|
|Study Director:||Jay S Pepose, MD, PhD||Lifelong Vision Foundation|
|Principal Investigator:||Parag A Majmudar, MD||Chicago Cornea Consultants|
|Principal Investigator:||Kevin L Waltz, OD, MD||Eye Surgeons of Indiana|
|Principal Investigator:||Jai Parekh, MD, MBA||Brar-Parekh Eye Associates|
|Principal Investigator:||Mujtaba A Qazi, MD||Lifelong Vision Foundation|
|Principal Investigator:||John Sheppard, MD||Virginia Eye Consultants|
|Principal Investigator:||Ruben L BonSiong, MD||Philippines General Hospital|