Viral Conjunctivitis Clinical Trial
Official title:
A Randomized, Double-Masked Trial of Topical Dexamethasone 0.1%/Povidone-iodine 0.4% Versus Artificial Tears for Treatment of Viral Conjunctivitis
Viral conjunctivitis causes redness, tearing, swelling, and irritation of the eyes that
typically lasts from 1 to 3 weeks. Current management of this condition focuses on
supportive care while the viral infection completes its course and resolves. However, many
patients still experience substantial discomfort despite standard treatments, and, given the
disproportionate morbidity and potential economic impact associated with an outbreak of
infective conjunctivitis, a therapeutic agent that reduces clinical symptoms of and
minimizes shedding of infectious virus would be desirable.
Povidone-iodine is an antiseptic extensively used in preparation for general surgery,
ophthalmic purposes, and laboratory disinfection. Dilute povidone-iodine solutions inhibit
numerous viruses, bacteria, fungi, and some other parasites. Low cost, effectiveness, and
lack of microbial resistance make povidone-iodine an appealing drug to treat ocular
infections, especially in developing countries. Previously studies showed that
povidone-iodine is a potential option to reduce contagiousness in cases of adenoviral
infections. Dexamethasone 0.1%/povidone-iodine 0.4% it is a mixture containing a steroid and
antiseptic is promising as a suitable therapeutic agent for the treatment of EKC. A small,
prospective, open-label, single-armed clinical trial of dexamethasone 0.1%/povidone-iodine
0.4% administration in humans with symptoms of acute conjunctivitis who tested positive for
adenoviral antigen was therapeutically successful. In other study, dexamethasone
0.1%/povidone-iodine 0.4% combination markedly lowered the viral concentration and improved
the manifestations of the disease.
So, the favorable human data in combination with in vivo results provide a strong impetus
for a human phase III clinical trial to test the efficacy of this drug in a larger group and
also to evaluate complete safety to properly establish the therapeutic benefit versus
adverse effect for these reasons, the investigators chose to study the efficacy of
dexamethasone 0.1%/povidone-iodine 0.4% in treating the symptoms and signs of viral
conjunctivitis. The administration of dexamethasone 0.1%/povidone-iodine 0.4% can be a
secure, tolerable and affective treatment to inflammatory and infective component of acute
viral conjunctivitis.
Status | Completed |
Enrollment | 100 |
Est. completion date | February 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - unilateral or asymmetric conjunctivitis, - follicles on the inferior tarsal conjunctiva, - preauricular lymphadenopathy, - an associated upper respiratory infection or - recent contact with a person with a red eye Exclusion Criteria: - history of seasonal allergic conjunctivitis, - use of ocular medication after the beginning of symptoms, - contact lens wear, - history of herpetic eye disease, - history of ocular surgery, - history of chronic ocular disease other than refractive error, - allergy to iodo, pregnancy, - age less than 18 years, - bleeding disorder, - glaucoma, - significant blepharitis or dry eyes on slit lamp examination, - purulent ocular discharge, - corneal epithelial staining with fluorescein, or - intraocular inflammation |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | University of Campinas | Campinas | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Campinas, Brazil |
Brazil,
2. Cullom RD Jr, Chang B, eds. The Wills Eye Manual: Office and Emergency Room Diagnosis and Treatment of Eye Diseases, 2nd ed. Philadelphia: J.B. Lippincott, 1994; chap 5.
O'Brien TP, Jeng BH, McDonald M, Raizman MB. Acute conjunctivitis: truth and misconceptions. Curr Med Res Opin. 2009 Aug;25(8):1953-61. doi: 10.1185/03007990903038269. Review. — View Citation
Romanowski EG, Roba LA, Wiley L, Araullo-Cruz T, Gordon YJ. The effects of corticosteroids of adenoviral replication. Arch Ophthalmol. 1996 May;114(5):581-5. — View Citation
Sambursky RP, Fram N, Cohen EJ. The prevalence of adenoviral conjunctivitis at the Wills Eye Hospital Emergency Room. Optometry. 2007 May;78(5):236-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Conjunctival injection | Patient´s information. Each of the symptoms was rated by the patient at presentation and at follow-up on a 4 point scale: none (0), mild (1), moderate (2), or severe (3). |
Day 5 of symptom | No |
Secondary | Conjunctival chemosis | Patient´s information. Each of the symptoms was rated by the patient at presentation and at follow-up on a 4 point scale: none (0), mild (1), moderate (2), or severe (3). |
Day 10 of symptom | No |
Secondary | Conjunctival chemosis | Patient´s information. Each of the symptoms was rated by the patient at presentation and at follow-up on a 4 point scale: none (0), mild (1), moderate (2), or severe (3). |
Day 30 of symptom | No |
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