Trial | NCT01600365  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    ganciclovir ...

  • Study Participants

    22
The purpose of this study is to study the use of ganciclovir gel 0.3% for treatment of conjunctivitis caused by adenovirus.
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.
Study Started
May 31
2012
Primary Completion
Jun 30
2012
Anticipated
Study Completion
Jun 30
2012
Anticipated
Last Update
May 17
2012
Estimate

Drug Ophthalmic gel (placebo)

Ophthalmic gel (placebo): applied in affected eye 4 times daily for 10 days

  • Other names: artificial tears

Drug Ganciclovir

Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days

  • Other names: ganciclovir gel

Ganciclovir Active Comparator

Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days

Ophthalmic gel (placebo) Placebo Comparator

ophthalmic gel (placebo)in the study eye

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.
No Results Posted