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Viroptic (Trifluridine Ophthalmic) - Summary

 
 



VIROPTIC SUMMARY

VIROPTIC is the brand name for trifluridine (also known as trifluorothymidine, F3TdR,F3T), an antiviral drug for topical treatment of epithelial keratitis caused by herpes simplex virus.

VIROPTIC Ophthalmic Solution, 1% (trifluridine ophthalmic solution) is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2.


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NEWS HIGHLIGHTS

Published Studies Related to Viroptic (Trifluridine Ophthalmic)

A prospective, masked clinical trial of trifluridine, dexamethasone, and artificial tears in the treatment of epidemic keratoconjunctivitis. [1993.05]
Epidemics of viral conjunctivitis are a major public health problem in the Far East. No treatment has been shown to shorten the duration of illness.This is the largest series of cases of epidemic keratoconjunctivitis with laboratory confirmation reported from the Philippines.

[Trifluridine therapy in herpetic in keratitis] [2004.04]
The objective of the study was to analyze the efficiency of trifluridine in the treatment of herpes infection of the cornea. The study was performed on a 60 patients group suffering of different forms of herpetic keratitis.The results of the study indicate trifluridine as an efficient antiviral drug which may be successfully used in the treatment of herpetic keratitis (superficial and stromal).

Comparative antiviral efficacies of cidofovir, trifluridine, and acyclovir in the HSV-1 rabbit keratitis model. [1999.02]
PURPOSE: To determine the relative antiviral inhibitory activity of topical 1% and 0.5% cidofovir, topical trifluridine (Viroptic; Burroughs-Wellcome, Research Triangle Park, NC), and topical acyclovir (Zovirax; The Wellcome Foundation, London, UK) during a 7-day period for the treatment of herpes simplex virus type 1 (HSV-1) keratitis and HSV-1 replication in the New Zealand rabbit ocular model... CONCLUSIONS: Topical 1% and 0.5% cidofovir both appeared to be significantly more efficacious than topical trifluridine and acyclovir, during a 7-day course, in the treatment of experimental HSV-1 ocular disease in the New Zealand rabbit keratitis model.

Trifluridine, cidofovir, and penciclovir in the treatment of experimental herpetic keratitis. [1998.06]
OBJECTIVE: To compare trifluridine eyedrops, cidofovir eyedrops, and penciclovir ophthalmic ointment for the treatment of herpes simplex virus type 1 keratitis... CONCLUSION: Trifluridine treatment was highly effective in this rabbit model, even when given only once a day. Treatment with cidofovir was as effective as that with trifluridine. CLINICAL RELEVANCE: Cidofovir and penciclovir treatments may prove to be effective against epithelial keratitis. Clinical trials of trifluridine, cidofovir, and penciclovir with lower treatment frequencies appear to be warranted.

Delivery of trifluridine to human cornea and aqueous using collagen shields. [1998.04]
PURPOSE: We investigated the ability of collagen shields to deliver trifluridine (trifluorothymidine [TFT]) to human cornea and aqueous humor... CONCLUSIONS: Collagen shields do not enhance delivery of TFT to corneas with intact epithelium. In corneas with poor epithelium, drug penetration was higher but variable. The role of collagen shields as a drug delivery system for the treatment of herpes simplex keratitis remains to be determined.

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Clinical Trials Related to Viroptic (Trifluridine Ophthalmic)

Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine [Completed]
To determine the safety, effectiveness, and toxicity of topical (local) trifluridine in treating mucocutaneous (at the nasal, oral, vaginal, and anal openings) Herpes simplex virus ( HSV ) disease that has shown resistance to acyclovir in HIV-infected patients. HSV infection in patients with AIDS is often associated with skin sores and frequent recurrences. Treatment with the drug acyclovir results in healing for most patients, but repeated treatment sometimes results in resistance of the virus to acyclovir. Thus, when this happens, other treatments need to be used. Trifluridine is an antiviral drug that is used for the treatment of Herpes infections that occur in the eye. This study attempts to determine if trifluridine is useful for treating HSV sores that have not healed after treatment with acyclovir.

Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone [Active, not recruiting]
The purpose of this study is to compare the pharmacokinetics of trifluorothymidine (FTD) as a component of TAS-102 with FTD alone.

Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study [Completed]

Herpetic Eye Disease Study (HEDS) I [Active, not recruiting]
To evaluate the efficacy of topical corticosteroids in treating herpes simplex stromal keratitis in conjunction with topical trifluridine. To evaluate the efficacy of oral acyclovir in treating herpes simplex stromal keratitis in patients receiving concomitant topical corticosteroids and trifluridine. To evaluate the efficacy of oral acyclovir in treating herpes simplex iridocyclitis in conjunction with treatment with topical corticosteroids and trifluridine.

Evaluation and Treatment of Eye Complications of Vaccinia Vaccination [Completed]
This study will evaluate patients with eye complications related to vaccination against smallpox to learn more about these conditions. Vaccinia vaccination has been used for more than 100 years for preventing smallpox. A small number of people who receive the vaccination (less than 1 in 1,000) develop complications, sometimes in their eyes. This usually results from the accidental transfer of the infection from the vaccination site to the face or eyes, perhaps by touching the vaccination area and then the face or eyelids before washing the hands. The study will also examine whether an experimental treatment called NP-016 vaccinia immune globulin can reduce corneal scarring that is sometimes associated with serious vaccinia complications and can impair vision. Children and adults with keratitis, severe conjunctivitis, or blepharitis following exposure to vaccinia vaccination may be eligible for this study. Children must weigh at least 10 kg. Participants undergo the following tests and procedures at enrollment, with some tests repeated at scheduled study visits: 1. Medical history and physical examination 2. Infectious disease consultation 3. Complete eye evaluation including:

- Fundus photography to examine the back of the eye - dilation of the pupils with

eye drops to examine and photograph the back of the eye

- Slit lamp biomicroscopy - evaluation of the front part of the eye with a slit lamp

microscope

- Eye pressure measurements

- Eye swab to look for vaccinia virus or other causes of disease

4. Blood tests 5. Photographs and documentation of eye and skin lesions 6. Vaccinia diagnostic tests, such as skin or mucosa scrapings; blood, throat, or urine cultures; and tissue biopsies, if needed Patients begin treatment with standard medications for their eye disease, such as trifluridine (Viroptic® (Registered Trademark)) anti-viral eye drops. Patients whose condition becomes serious are offered additional treatment with intravenous (through a vein) infusions of either VIG or placebo (salt water solution with no active drug) and are randomly assigned to one or the other treatment group. All patients continue standard-of-care treatment as well. Follow-up visits at the NIH eye clinic are scheduled as required by the patient's condition. Patients with mild complications who are taking only standard medications may need to be seen only 1 month after the initial visit and then 6 months and 12 months later. Patients with more serious conditions who qualify for VIG or placebo treatments may be seen daily for a week, then once a week for the rest of the first month, and then at 6 months and 12 months, unless more frequent treatment or observation is required.

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Page last updated: 2008-08-10

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