Evaluate the Use of Ganciclovir Gel 0.3% for the Treatment of Conjunctivitis Caused by Adenovirus

• ClinicalTrials.gov Identifier: NCT01600365
• Recruitment Status: Unknown
• First Posted: May 17, 2012
• Last Update Posted: May 17, 2012
• Sponsor: Adapt Produtos Oftalmológicos Ltda.
• Information provided by (Responsible Party): Adapt Produtos Oftalmológicos Ltda.

Tracking Information

• First Submitted Date: March 22, 2011
• First Posted Date: May 17, 2012
• Last Update Posted Date: May 17, 2012
• Study Start Date: May 2012
• Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 15, 2012)

time to regression of the ocular symptomatology [ Time Frame: 10 days ]

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 15, 2012)

• Development of sub-epithelial infiltrates [ Time Frame: 10 days ]
  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 ]
  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 ]
  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 ]
  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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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."
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Conjunctivitis
• Adenovirus.

Intervention

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

Study Arms

• Active Comparator: Ganciclovir
  Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days
  Intervention: Drug: Ganciclovir
• Placebo Comparator: Ophthalmic gel (placebo)
  ophthalmic gel (placebo)in the study eye
  Intervention: Drug: Ophthalmic gel (placebo)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 15, 2012): 22
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2012
• Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01600365
• Other Study ID Numbers: ADA-GAN-02/10
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Adapt Produtos Oftalmológicos Ltda.
• Original Responsible Party: Same as current
• Current Study Sponsor: Adapt Produtos Oftalmológicos Ltda.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Rubens Belfort, PhD, MD; Federal University of São Paulo

• PRS Account: Adapt Produtos Oftalmológicos Ltda.
• Verification Date: May 2012