Viral ConjunctivitisPhase 3NCT01481519
A Trial of Topical Dexamethasone Versus Artificial Tears for Treatment of Viral Conjunctivitis
A Phase 3 study testing dexamethasone 0.1%/povidone-iodine 0.4% and Artificial Tears in people with Viral Conjunctivitis, run by University of Campinas, Brazil at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Viral Conjunctivitis
- What is being tested?
- dexamethasone 0.1%/povidone-iodine 0.4% and Artificial Tears
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2011to Feb 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Masked Trial of Topical Dexamethasone 0.1%/Povidone-iodine 0.4% Versus Artificial Tears for Treatment of Viral Conjunctivitis
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.
Read the 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).
- Conditions
- Viral Conjunctivitis
- Being tested
- dexamethasone 0.1%/povidone-iodine 0.4%, Artificial Tears
- Keywords
- Conjunctivitis, Ocular diseases, Artificial tears
- Medical subject headings
- Conjunctivitis, Viral, Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasone 0.1%/povidone-iodine 0.4%Drug
Also called Dexamethasone / Iodo - povidone
dexamethasone 0.1%/povidone-iodine 0.4%
Artificial TearsDrug
artificial tears 1 drop, 4 times per day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Artificial Tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 5 of symptom
Secondary outcomes (2)
Conjunctival chemosis
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).
Measured: Day 10 of symptom
Conjunctival chemosis
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).
Measured: Day 30 of symptom
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Viral ConjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joao Paulo Felix, University of Campinas, Brazil
- Investigators
- Rodrigo Pessoa C Lira, Study chair, University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481519
- Sponsor's protocol ID
- 0664.0.146.000-11
- Status last verified
- Dec 2014
- First submitted
- 13 Nov 2011
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17478342O'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.
PubMed 19552618Romanowski 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.
PubMed 86197692. 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked Trial of Topical Dexamethasone 0.1%/Povidone-iodine 0.4% Versus Artificial Tears for Treatment of Viral Conjunctivitis
- ClinicalTrials.gov ID
- NCT01481519
- Acronym / sponsor ID
- 0664.0.146.000-11
- Conditions
- Viral Conjunctivitis
- Keywords
- Conjunctivitis, Ocular diseases, Artificial tears
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone 0.1%/povidone-iodine 0.4% | Active comparator | Drug: dexamethasone 0.1%/povidone-iodine 0.4%Patients were instructed to put one drop into each symptomatic eye four times daily for 7 days. |
| artificial tears | Placebo comparator | Drug: Artificial TearsPatients were instructed to put one drop into each symptomatic eye four times daily for 7 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasone 0.1%/povidone-iodine 0.4%Also: Dexamethasone / Iodo - povidonedexamethasone 0.1%/povidone-iodine 0.4% | Drug | dexamethasone 0.1%/povidone-iodine 0.4% |
| Artificial Tearsartificial tears 1 drop, 4 times per day | Drug | artificial tears |
Primary outcome
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).
2 secondary outcomes
Conjunctival chemosis
Time frame: Day 10 of symptom
Conjunctival chemosis
Time frame: Day 30 of symptom
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
- Background: PubMed 17478342Sambursky 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.
- Background: PubMed 19552618O'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.
- Background: PubMed 8619769Romanowski 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.
- Results publication2. 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.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo Pessoa C Lira study chair
University of Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dexamethasone 0.1%/povidone-iodine 0.4% and Artificial Tears in people with Viral Conjunctivitis, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conjunctival injection (time frame: Day 5 of symptom). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01481519, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2014.