Back to resultsEvaluate the Use of Ganciclovir Gel 0.3% for the Treatment of Conjunctivitis Caused by Adenovirus
Primary Purpose
Conjunctivitis, Adenovirus.
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ophthalmic gel (placebo)
Ganciclovir
Sponsored by
About this trial
This is an interventional treatment trial for Conjunctivitis focused on measuring Conjunctivitis, adenovirus.
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ganciclovir
Ophthalmic gel (placebo)
Arm Description
Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days
ophthalmic gel (placebo)in the study eye
Outcomes
Primary Outcome Measures
time to regression of the ocular symptomatology
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
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
Degree of bulbar conjunctival injection at each follow-up visit, based on the scale of mild, moderate and severe
Involvement of the second eye
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
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)
Full Information
NCT ID
NCT01600365
First Posted
March 22, 2011
Last Updated
May 15, 2012
Sponsor
Adapt Produtos Oftalmológicos Ltda.
1. Study Identification
Unique Protocol Identification Number
NCT01600365
Brief Title
Evaluate the Use of Ganciclovir Gel 0.3% for the Treatment of Conjunctivitis Caused by Adenovirus
Official Title
"Prospective, Interventional, Randomized, Double-masked With the Use of Ganciclovir Gel 0.3% for Treatment of Conjunctivitis Caused by Adenovirus."
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adapt Produtos Oftalmológicos Ltda.
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Conjunctivitis, Adenovirus.
Keywords
Conjunctivitis, adenovirus.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ganciclovir
Arm Type
Active Comparator
Arm Description
Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days
Arm Title
Ophthalmic gel (placebo)
Arm Type
Placebo Comparator
Arm Description
ophthalmic gel (placebo)in the study eye
Intervention Type
Drug
Intervention Name(s)
Ophthalmic gel (placebo)
Other Intervention Name(s)
artificial tears
Intervention Description
Ophthalmic gel (placebo): applied in affected eye 4 times daily for 10 days
Intervention Type
Drug
Intervention Name(s)
Ganciclovir
Other Intervention Name(s)
ganciclovir gel
Intervention Description
Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days
Primary Outcome Measure Information:
Title
time to regression of the ocular symptomatology
Description
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.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Development of sub-epithelial infiltrates
Description
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)
Time Frame
10 days
Title
Degree of Bulbar conjunctival Injection
Description
Degree of bulbar conjunctival injection at each follow-up visit, based on the scale of mild, moderate and severe
Time Frame
10 days
Title
Involvement of the second eye
Description
Involvement of the second eye - incidence for the study duration and severity at each follow-up visit, as determined by the clinical evaluation (biomicroscopy)
Time Frame
10 days
Title
Patient Dairy - intensity of ocular pain
Description
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)
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rubens Belfort, PhD, MD
Phone
5511 55726443
Email
rogeriomazon@adaptltda.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Muccioli, MD
Phone
5511 55726443
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rubens Belfort, PhD, MD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Evaluate the Use of Ganciclovir Gel 0.3% for the Treatment of Conjunctivitis Caused by Adenovirus
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