A Placebo Controlled Comparison of Topical Zirgan Versus Genteal Gel for the Treatment of Adenovirus Conjunctivitis

Summary

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.

Conditions

• Keratoconjunctivitis Due to Adenovirus
• Viral Shedding

Interventions

DRUG

Zirgan

0.15% ganciclovir gel(Zirgan)

DRUG

genteal gel

0.3% Hypromellose gel

Sponsors & Collaborators

• Bausch & Lomb Incorporated

  collaborator INDUSTRY

• Lifelong Vision Foundation

  lead OTHER

Principal Investigators

• Jay S Pepose, MD, PhD · Lifelong Vision Foundation

• Parag A Majmudar, MD · Chicago Cornea Consultants

• Kevin L Waltz, OD, MD · Eye Surgeons of Indiana

• Jai Parekh, MD, MBA · Brar-Parekh Eye Associates

• Mujtaba A Qazi, MD · Lifelong Vision Foundation

• John Sheppard, MD · Virginia Eye Consultants

• Ruben L BonSiong, MD · Philippines General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2014-12-31

Completion

2016-04-30

Countries

• United States

Study Locations