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

Adapt Pharma

Status and phase: Unknown; Phase 3

Conditions: Conjunctivitis; Adenovirus.

Treatments: Drug: Ophthalmic gel (placebo); Drug: Ganciclovir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01600365

ADA-GAN-02/10

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups, including a placebo group

Ganciclovir

Active Comparator group

Description:

Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days

Treatment:

Drug: Ganciclovir

Ophthalmic gel (placebo)

Placebo Comparator group

Description:

ophthalmic gel (placebo)in the study eye

Treatment:

Drug: Ophthalmic gel (placebo)