A Trial of Topical Dexamethasone Versus Artificial Tears for Treatment of Viral Conjunctivitis
Condition: Viral Conjunctivitis
MeSH terms: Conjunctivitis, Viral; Conjunctivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): dexamethasone 0.1%/povidone-iodine 0.4%; Artificial Tears
Intervention type(s): Drug; Drug
Intervention description(s): dexamethasone 0.1%/povidone-iodine 0.4%; artificial tears 1 drop, 4 times per day
Other intervention name(s): Dexamethasone / Iodo - povidone
Intervention MeSH terms: Povidone-Iodine; Dexamethasone; Dexamethasone acetate; Povidone; Lubricant Eye Drops; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Conjunctivitis; Ocular diseases; Artificial tears