Trial record 10 of 34 for:    Open Studies | "Eye Infections"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Campinas, Brazil
Sponsor:
Information provided by (Responsible Party):
Joao Paulo Felix, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT01481519
First received: November 13, 2011
Last updated: November 25, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Viral Conjunctivitis
Drug: dexamethasone 0.1%/povidone-iodine 0.4%
Drug: Artificial Tears
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Masked Trial of Topical Dexamethasone 0.1%/Povidone-iodine 0.4% Versus Artificial Tears for Treatment of Viral Conjunctivitis

Resource links provided by NLM:


Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • Conjunctival injection [ Time Frame: Day 5 of symptom ] [ Designated as safety issue: No ]

    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).



Secondary Outcome Measures:
  • Conjunctival chemosis [ Time Frame: Day 10 of symptom ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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).



Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: dexamethasone 0.1%/povidone-iodine 0.4%
dexamethasone 0.1%/povidone-iodine 0.4%
Other Name: Dexamethasone / Iodo - povidone
Placebo Comparator: artificial tears
Patients were instructed to put one drop into each symptomatic eye four times daily for 7 days.
Drug: Artificial Tears
artificial tears 1 drop, 4 times per day

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).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481519

Contacts
Contact: Rodrigo Pessoa C Lira 019 3521 7396

Locations
Brazil
University of Campinas Recruiting
Campinas, São Paulo, Brazil
Contact: Hospital das Clinicas    19 3521 7396      
Principal Investigator: Rodrigo Pessoa C Lira         
Sub-Investigator: João Paulo F Felix         
Sub-Investigator: Roberto Damian Pacheco         
Sub-Investigator: André Venancio F Pereira         
Sub-Investigator: Ricardo Abe         
Sub-Investigator: Rafael Zacchia         
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Study Chair: Rodrigo Pessoa C Lira University of Campinas
  More Information

Additional Information:
Publications:
Responsible Party: Joao Paulo Felix, Dr., University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01481519     History of Changes
Other Study ID Numbers: 0664.0.146.000-11
Study First Received: November 13, 2011
Last Updated: November 25, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
Conjunctivitis
Ocular diseases
Artificial tears

Additional relevant MeSH terms:
Eye Infections, Viral
Eye Infections
Conjunctivitis
Conjunctivitis, Viral
Conjunctival Diseases
Eye Diseases
Virus Diseases
Ophthalmic Solutions
Povidone
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Iodine
Cadexomer iodine
Povidone-Iodine
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids

ClinicalTrials.gov processed this record on August 01, 2014