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

Study Status: Withdrawn
Recruit Status: Unknown status
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: Adapt Produtos Oftalmológicos Ltda.

Current Primary Outcome: time to regression of the ocular symptomatology [ Time Frame: 10 days ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Development of sub-epithelial infiltrates [ Time Frame: 10 days ]
    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 ]
    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 ]
    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 ]
    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)


Original Secondary Outcome: Same as current

Information By: Adapt Produtos Oftalmológicos Ltda.

Dates:
Date Received: March 22, 2011
Date Started: May 2012
Date Completion: June 2012
Last Updated: May 15, 2012
Last Verified: May 2012