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

Sponsor

Adapt Produtos Oftalmológicos Ltda. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01600365

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Conjunctivitis Adenovirus.	Drug: Ophthalmic gel (placebo) Drug: Ganciclovir	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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."

Study Start Date :

May 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2012

Anticipated Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: artificial tears

Arm

Intervention/Treatment

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 Names:

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 Names:

artificial tears

Outcome Measures

Primary Outcome Measures

time to regression of the ocular symptomatology [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.

Secondary Outcome Measures

Development of sub-epithelial infiltrates [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 [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 [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.