A Trial of Topical Dexamethasone Versus Artificial Tears for Treatment of Viral Conjunctivitis
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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 |
- 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).
- 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 |
| Study Completion Date: | February 2013 |
| 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 (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01481519
| Brazil | |
| University of Campinas | |
| Campinas, São Paulo, Brazil | |
| 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: | December 2, 2014 |
| 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:
|
Conjunctivitis Conjunctivitis, Viral Conjunctival Diseases Eye Diseases Eye Infections, Viral Virus Diseases Eye Infections Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Iodine Cadexomer iodine Povidone-Iodine Lubricant Eye Drops |
Povidone Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 30, 2016