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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ophthalmic gel (placebo) | Drug | Ophthalmic gel (placebo): applied in affected eye 4 times daily for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Degree of Bulbar conjunctival Injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rubens Belfort, PhD, MD | Contact | 5511 55726443 | rogeriomazon@adaptltda.com.br | |
| Cristina Muccioli, MD | Contact | 5511 55726443 |
| Name | Affiliation | Role |
|---|---|---|
| Rubens Belfort, PhD, MD | Federal University of São Paulo | Principal Investigator |
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| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D000257 | Adenoviridae Infections |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D065346 | Lubricant Eye Drops |
| D015774 | Ganciclovir |
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Ganciclovir | Drug | Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days |
|
|
Degree of bulbar conjunctival injection at each follow-up visit, based on the scale of mild, moderate and severe |
| 10 days |
| 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 |
| 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 |
| D007239 |
| Infections |
| D045506 |
| Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |
| D000212 | Acyclovir |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |