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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Lifelong Vision Foundation
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Lifelong Vision Foundation
ClinicalTrials.gov Identifier:
NCT01533480
First received: January 31, 2012
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Keratoconjunctivitis Due to Adenovirus
Viral Shedding
Drug: Zirgan
Drug: genteal gel
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Lifelong Vision Foundation:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 80
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)
Arms Assigned Interventions
Active Comparator: Zirgan, Adenovirus conjunctivitis,
Zirgan
Drug: Zirgan
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

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients must be 14 years of age or older. Patients under age 18 will require parental consent for entry.
  2. Give written informed consent and use or release of health and research study information.
  3. Patients must be able and willing to comply with all treatment and follow-up/study procedures.
  4. Patients must have a follicular conjunctivitis and present within 3 days of the onset of symptoms in the first eye.
  5. Patients must agree not to wear contact lenses for 14 days while taking study medications.

Exclusion Criteria:

  1. Severe dry eye or Sjögren's Syndrome.
  2. Corneal graft in either eye.
  3. Participation in an investigational study within the past 30 days.
  4. Inability to understand instructions or comply with the study visit schedule.
  5. Uniocular vision status.
  6. Best corrected visual acuity worse than 20/200 in either eye.
  7. Uveitis or iritis which requires treatment with corticosteroids.
  8. Mucopurulent discharge.
  9. Signs of any other viral, fungal, bacterial infection.
  10. Congenital, acquired, or iatrogenic immune deficiency.
  11. Treatment with systemic or topical ocular antiviral agents or systemic or topical steroids or topical ocular NSAIDS during the prior 14-day period.
  12. Presence of subepithelial infiltrates.
  13. 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).
  14. Pregnancy test positive for women of child bearing age or women breastfeeding children or women not practicing accepted method(s) of contraception.
  15. Active allergic conjunctivitis
  16. History of atopic disease.
  17. Known hypersensitivity or allergy to ganciclovir or to BAK or to any of the ingredients in the study drugs
  18. Acute eye trauma.
  19. Contact lens only with no spectacles available.
  20. 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.
  21. Ocular surgery (including laser surgery) in either eye within six weeks prior to entry into this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533480

Contacts
Contact: Farrah J Shaikh, COA, 636-534-5126 fshaikh@peposevision.com
Contact: Jay S Pepose, MD, PhD 314-809-4566 jpepose@peposevision.com

Locations
United States, Missouri
Lifelong Vision Foundation Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Farrah J Shaikh, COA    636-534-5126      
Contact: Jay S Pepose, MD, PhD    636-728-0111    jpepose@peposevision.com   
Sponsors and Collaborators
Lifelong Vision Foundation
Bausch & Lomb Incorporated
Investigators
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
  More Information

No publications provided

Responsible Party: Lifelong Vision Foundation
ClinicalTrials.gov Identifier: NCT01533480     History of Changes
Other Study ID Numbers: ADV-GAN-10-2011, pro00006720
Study First Received: January 31, 2012
Last Updated: September 8, 2014
Health Authority: United States: Institutional Review Board
Philippines: FDA, Regulatory Authority

Keywords provided by Lifelong Vision Foundation:
Adenovirus
Conjunctivitis
keratoconjunctivitis
viral shedding
subepithelial infiltrate
bulbar injection

Additional relevant MeSH terms:
Adenoviridae Infections
Conjunctivitis
Keratoconjunctivitis
Conjunctival Diseases
Eye Diseases
DNA Virus Infections
Virus Diseases
Keratitis
Corneal Diseases
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014