A Trial of Topical Dexamethasone Versus Artificial Tears for Treatment of Viral Conjunctivitis
Information source: University of Campinas, Brazil
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Viral Conjunctivitis
Intervention: dexamethasone 0.1%/povidone-iodine 0.4% (Drug); Artificial Tears (Drug)
Phase: Phase 3
Sponsored by: University of Campinas, Brazil
Official(s) and/or principal investigator(s):
Rodrigo Pessoa C Lira, Study Chair, Affiliation: University of Campinas
Rodrigo Pessoa C Lira, Phone: 019 3521 7396
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
Official title: A Randomized, Double-Masked Trial of Topical Dexamethasone 0.1%/Povidone-iodine 0.4% Versus Artificial Tears for Treatment of Viral Conjunctivitis
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Conjunctival injection
Patients who met the study criteria and who agreed to participate in the study were randomly
assigned to receive either dexamethasone 0. 1%/povidone-iodine 0. 4% or artificial tears.
Sealed, randomly numbered opaque manila envelopes containing unlabeled bottles of either
dexamethasone 0. 1%/povidone-iodine 0. 4% or artificial tears were given to the patient.
Patients were instructed to put one drop into each symptomatic eye four times daily for 7
days. The identity of the drops was masked to both the investigators and patients until the
study was closed. At the end of the study, the code for the randomization scheme was
obtained. This study was approved by an ethics committee linked to the Institution of
origin, and written informed consent was obtained from all patients.
Patients were evaluated at baseline and were asked to return either 5, 10 and 30 days later
for a follow-up evaluation. The principal efficacy variables were six symptoms of viral
conjunctivitis: overall discomfort, itching, foreign body sensation, tearing, redness, and
lid swelling. Four signs of viral conjunctivitis were also evaluated: conjunctival
injection, conjunctival chemosis, conjunctival mucus, and lid edema.
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). In addition, each patient was asked
to report their opinion on the usefulness of the treatment in relieving their symptoms on a
4-point scale: did not help (0), unsure (1), think it helped (2), and sure it helped (3).
Minimum age: 18 Years.
Maximum age: 60 Years.
- 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
- 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,
- significant blepharitis or dry eyes on slit lamp examination,
- purulent ocular discharge,
- corneal epithelial staining with fluorescein, or
- intraocular inflammation
Locations and Contacts
Rodrigo Pessoa C Lira, Phone: 019 3521 7396
University of Campinas, Campinas, São Paulo, Brazil; Recruiting
Hospital das Clinicas, Phone: 19 3521 7396
Rodrigo Pessoa C Lira, Principal Investigator
João Paulo F Felix, Sub-Investigator
Roberto Damian Pacheco, Sub-Investigator
André Venancio F Pereira, Sub-Investigator
Ricardo Abe, Sub-Investigator
Rafael Zacchia, Sub-Investigator
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.
O'Brien TP, Jeng BH, McDonald M, Raizman MB. Acute conjunctivitis: truth and misconceptions. Curr Med Res Opin. 2009 Aug;25(8):1953-61. Review.
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.
Starting date: December 2011
Last updated: November 25, 2012