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A Trial of Topical Dexamethasone Versus Artificial Tears for Treatment of Viral Conjunctivitis

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ClinicalTrials.gov Identifier: NCT01481519
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : December 4, 2014
Sponsor:
Information provided by (Responsible Party):
Joao Paulo Felix, University of Campinas, Brazil

Tracking Information
First Submitted Date  ICMJE November 13, 2011
First Posted Date  ICMJE November 29, 2011
Last Update Posted Date December 4, 2014
Study Start Date  ICMJE December 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2011)
Conjunctival injection [ Time Frame: Day 5 of symptom ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01481519 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2011)
  • Conjunctival chemosis [ Time Frame: Day 10 of symptom ]
    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).
  • Conjunctival chemosis [ Time Frame: Day 30 of symptom ]
    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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Topical Dexamethasone Versus Artificial Tears for Treatment of Viral Conjunctivitis
Official Title  ICMJE A Randomized, Double-Masked Trial of Topical Dexamethasone 0.1%/Povidone-iodine 0.4% Versus Artificial Tears for Treatment of Viral Conjunctivitis
Brief 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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Viral Conjunctivitis
Intervention  ICMJE
  • Drug: dexamethasone 0.1%/povidone-iodine 0.4%
    dexamethasone 0.1%/povidone-iodine 0.4%
    Other Name: Dexamethasone / Iodo - povidone
  • Drug: Artificial Tears
    artificial tears 1 drop, 4 times per day
Study Arms  ICMJE
  • Active Comparator: dexamethasone 0.1%/povidone-iodine 0.4%
    Patients were instructed to put one drop into each symptomatic eye four times daily for 7 days.
    Intervention: Drug: dexamethasone 0.1%/povidone-iodine 0.4%
  • Placebo Comparator: artificial tears
    Patients were instructed to put one drop into each symptomatic eye four times daily for 7 days.
    Intervention: Drug: Artificial Tears
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 28, 2011)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01481519
Other Study ID Numbers  ICMJE 0664.0.146.000-11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joao Paulo Felix, University of Campinas, Brazil
Study Sponsor  ICMJE University of Campinas, Brazil
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Rodrigo Pessoa C Lira University of Campinas
PRS Account University of Campinas, Brazil
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP