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

NCT01481519 | Completed Phase 3 DMC

• 1 other identifier: 0664.0.146.000-11
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Viral Conjunctivitis

Keywords

Conjunctivitis; Ocular diseases; Artificial tears

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Conjunctival chemosis

  Day 10 of symptom

• Conjunctival chemosis

  Day 30 of symptom

Study Arms (2)

dexamethasone 0.1%/povidone-iodine 0.4%

ACTIVE COMPARATOR

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%

artificial tears

PLACEBO COMPARATOR

Patients were instructed to put one drop into each symptomatic eye four times daily for 7 days.

Drug: Artificial Tears

Interventions

dexamethasone 0.1%/povidone-iodine 0.4% DRUG

dexamethasone 0.1%/povidone-iodine 0.4%

Also known as: Dexamethasone / Iodo - povidone

dexamethasone 0.1%/povidone-iodine 0.4%

Artificial Tears DRUG

artificial tears 1 drop, 4 times per day

artificial tears

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

University of Campinas

Campinas, São Paulo, Brazil

Location

Related Publications (4)

• 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. doi: 10.1016/j.optm.2006.11.012.

  PMID: 17478342 BACKGROUND

• 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.

  PMID: 19552618 BACKGROUND

• 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. doi: 10.1001/archopht.1996.01100130573014.

  PMID: 8619769 BACKGROUND

• 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.

  RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Conjunctivitis, Viral; Conjunctivitis

Interventions

Dexamethasone; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Eye Infections, Viral; Eye Infections; Infections; Virus Diseases; Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Officials

• Rodrigo Pessoa C Lira

  University of Campinas

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 13, 2011
• First Posted: November 29, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: February 1, 2013
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

BR (1)