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."
1 other identifier
interventional
22
0 countries
N/A
Brief Summary
The purpose of this study is to study the use of ganciclovir gel 0.3% for treatment of conjunctivitis caused by adenovirus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2012
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2011
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedFirst Posted
Study publicly available on registry
May 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedMay 17, 2012
May 1, 2012
1 month
March 22, 2011
May 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
10 days
Secondary Outcomes (4)
Development of sub-epithelial infiltrates
10 days
Degree of Bulbar conjunctival Injection
10 days
Involvement of the second eye
10 days
Patient Dairy - intensity of ocular pain
10 days
Study Arms (2)
Ganciclovir
ACTIVE COMPARATOROphthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days
Ophthalmic gel (placebo)
PLACEBO COMPARATORophthalmic gel (placebo)in the study eye
Interventions
Ophthalmic gel (placebo): applied in affected eye 4 times daily for 10 days
Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rubens Belfort, PhD, MD
Federal University of São Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2011
First Posted
May 17, 2012
Study Start
May 1, 2012
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
May 17, 2012
Record last verified: 2012-05