Evaluate the Use of Ganciclovir Gel 0.3% for the Treatment of Conjunctivitis Caused by Adenovirus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Adapt Produtos Oftalmológicos Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Adapt Produtos Oftalmológicos Ltda.
ClinicalTrials.gov Identifier:
NCT01600365
First received: March 22, 2011
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

The purpose of this study is to study the use of ganciclovir gel 0.3% for treatment of conjunctivitis caused by adenovirus.


Condition Intervention Phase
Conjunctivitis
Adenovirus.
Drug: Ophthalmic gel (placebo)
Drug: Ganciclovir
Phase 3

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: "Prospective, Interventional, Randomized, Double-masked With the Use of Ganciclovir Gel 0.3% for Treatment of Conjunctivitis Caused by Adenovirus."

Resource links provided by NLM:


Further study details as provided by Adapt Produtos Oftalmológicos Ltda.:

Primary Outcome Measures:
  • time to regression of the ocular symptomatology [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Time to regression of ocular symptomatology compared to the baseline, as determined by clinical evaluation (biomicroscopy) performed on V1, V2 and V3, based on scale of absent, mild, moderate and severe.


Secondary Outcome Measures:
  • Development of sub-epithelial infiltrates [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Development of sub-epithelial infiltrates,incidence for the study duration and severity at each follow-up visit (based on scale of absent, mild, moderate and severe)

  • Degree of Bulbar conjunctival Injection [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Degree of bulbar conjunctival injection at each follow-up visit, based on the scale of mild, moderate and severe

  • Involvement of the second eye [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Involvement of the second eye - incidence for the study duration and severity at each follow-up visit, as determined by the clinical evaluation (biomicroscopy)

  • Patient Dairy - intensity of ocular pain [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    intensity of ocular pain selected by the patient on the "Patient Dairy" based on the visual analogue scale (VAS)on each follow-up visit (absent, mild, moderate, severe)


Estimated Enrollment: 22
Study Start Date: May 2012
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ganciclovir
Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days
Drug: Ganciclovir
Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days
Other Name: ganciclovir gel
Placebo Comparator: Ophthalmic gel (placebo)
ophthalmic gel (placebo)in the study eye
Drug: Ophthalmic gel (placebo)
Ophthalmic gel (placebo): applied in affected eye 4 times daily for 10 days
Other Name: artificial tears

Detailed Description:

To evaluate the efficacy and tolerability of ganciclovir ophthalmic gel for the treatment of conjunctivitis comparing to placebo (ophthalmic gel). Visual acuity test and slit lamp examination (biomicroscopy) will be performed at each visit to assess the signs/symptoms and the regression of the disease.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with eye disease with a clinical diagnosis of adenovirus conjunctivitis.
  • Patients of both gender aged over 18 years.
  • Patients who are not pregnant or nursing.
  • Patients able (legally and mentally) to understand and sign informed consent had been signed.

Exclusion Criteria:

  • Patients who are in the presence of corticosteroids, either by topical ocular, periocular, intraocular or systemic, for less than 30 days of enrollment and who can not make a drug suspension.
  • Patients with serious systemic diseases like AIDS, cancer, etc., which in the opinion of the investigator, may put the patient at risk.
  • Patient with a single eye or vision in one eye.
  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: NCT01600365

Contacts
Contact: Rubens Belfort, PhD, MD 5511 55726443 rogeriomazon@adaptltda.com.br
Contact: Cristina Muccioli, MD 5511 55726443

Sponsors and Collaborators
Adapt Produtos Oftalmológicos Ltda.
Investigators
Principal Investigator: Rubens Belfort, PhD, MD Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Adapt Produtos Oftalmológicos Ltda.
ClinicalTrials.gov Identifier: NCT01600365     History of Changes
Other Study ID Numbers: ADA-GAN-02/10
Study First Received: March 22, 2011
Last Updated: May 15, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Adapt Produtos Oftalmológicos Ltda.:
Conjunctivitis
adenovirus.

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

ClinicalTrials.gov processed this record on September 22, 2014