Trial record 11 of 87 for:
Open Studies | "Conjunctivitis"
Evaluate the Use of Ganciclovir Gel 0.3% for the Treatment of Conjunctivitis Caused by Adenovirus
This study is not yet open for participant recruitment.
Verified May 2012 by Adapt Produtos Oftalmológicos Ltda.
Sponsor:
Adapt Produtos Oftalmológicos Ltda.
Information provided by (Responsible Party):
Adapt Produtos Oftalmológicos Ltda.
ClinicalTrials.gov Identifier:
NCT01600365
First received: March 22, 2011
Last updated: May 15, 2012
Last verified: May 2012
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Purpose
The purpose of this study is to study the use of ganciclovir gel 0.3% for treatment of conjunctivitis caused by adenovirus.
| Condition | Intervention | Phase |
|---|---|---|
|
Conjunctivitis Adenovirus. |
Drug: Ophthalmic gel (placebo) Drug: Ganciclovir |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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." |
Resource links provided by NLM:
Further study details as provided by Adapt Produtos Oftalmológicos Ltda.:
Primary Outcome Measures:
- time to regression of the ocular symptomatology [ Time Frame: 10 days ] [ Designated as safety issue: No ]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 [ Time Frame: 10 days ] [ Designated as safety issue: No ]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 [ Time Frame: 10 days ] [ Designated as safety issue: No ]Degree of bulbar conjunctival injection at each follow-up visit, based on the scale of mild, moderate and severe
- Involvement of the second eye [ Time Frame: 10 days ] [ Designated as safety issue: No ]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 [ Time Frame: 10 days ] [ Designated as safety issue: No ]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)
| Estimated Enrollment: | 22 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: artificial tears
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01600365
Contacts
| Contact: Rubens Belfort, PhD, MD | 5511 55726443 | rogeriomazon@adaptltda.com.br |
| Contact: Cristina Muccioli, MD | 5511 55726443 |
Sponsors and Collaborators
Adapt Produtos Oftalmológicos Ltda.
Investigators
| Principal Investigator: | Rubens Belfort, PhD, MD | Federal University of São Paulo |
More Information
No publications provided
| Responsible Party: | Adapt Produtos Oftalmológicos Ltda. |
| ClinicalTrials.gov Identifier: | NCT01600365 History of Changes |
| Other Study ID Numbers: | ADA-GAN-02/10 |
| Study First Received: | March 22, 2011 |
| Last Updated: | May 15, 2012 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by Adapt Produtos Oftalmológicos Ltda.:
|
Conjunctivitis adenovirus. |
Additional relevant MeSH terms:
|
Conjunctivitis Adenoviridae Infections DNA Virus Infections Virus Diseases Conjunctival Diseases Eye Diseases |
Ganciclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013