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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01600365
Other study ID # ADA-GAN-02/10
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received March 22, 2011
Last updated May 15, 2012
Start date May 2012
Est. completion date June 2012

Study information

Verified date May 2012
Source Adapt Produtos Oftalmológicos Ltda.
Contact Rubens Belfort, PhD, MD
Phone 5511 55726443
Email rogeriomazon@adaptltda.com.br
Is FDA regulated No
Health authority Brazil: National Health Surveillance Agency
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 22
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ophthalmic gel (placebo)
Ophthalmic gel (placebo): applied in affected eye 4 times daily for 10 days
Ganciclovir
Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Adapt Produtos Oftalmológicos Ltda.

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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) 10 days No
Secondary Degree of Bulbar conjunctival Injection Degree of bulbar conjunctival injection at each follow-up visit, based on the scale of mild, moderate and severe 10 days No
Secondary 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) 10 days No
Secondary 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) 10 days No
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