Viral ConjunctivitisPhase 4NCT01179412
Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine
A Phase 4 study testing 2% povidone-iodine in people with Viral Conjunctivitis, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine the outcomes of treating epidemic keratoconjunctivitis with 2% povidone-iodine. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Viral Conjunctivitis
- What is being tested?
- 2% povidone-iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2004to Dec 2009
- Phase
- Phase 4
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients who were diagnosed with EKC at the outpatient ophthalmic unit
Who cannot join
- children younger than six years
- women being pregnant or during lactation
- history of allergy to povidone-iodine
- prior ocular surgery
- contact lens usage and chronic eye diseases with current eye medications.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Ophthalmology, Siriraj Hospital Mahidol University
Bangkoknoi, Bangkok, 10700
About this study
The purpose of this study is to determine the outcomes of treating epidemic keratoconjunctivitis with 2% povidone-iodine.
Read the detailed description
The study design was a prospective interventional case series. Our institutional ethical committee approved the study protocol in April 2004. We performed this study between July 2004 and December 2009. During this period, there were 2 episodes of EKC epidemic. The first episode was in 2006 and the second in 2009.
- Conditions
- Viral Conjunctivitis
- Being tested
- 2% povidone-iodine
- Medical subject headings
- Conjunctivitis, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% povidone-iodineDrug
Also called PVP-I
apply 4 times a day for one week
2% povidone-iodineDrug
Also called PVP-I
apply 2% povidone-iodine 4 times per day for one week
| Study group | Role | What they receive |
|---|---|---|
| 2% povidone-iodine | Experimental | Not described Receives: Drug: 2% povidone-iodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the recovery rate within one week of treatment
Measured: 1 week
Secondary outcomes (1)
drug tolerability
proportion of patient who can continue topical application of povidone-iodine for a week or until EKC subsides
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startJul 2004
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral ConjunctivitisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Adisak Trinavarat, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179412
- Sponsor's protocol ID
- EKC2004
- Status last verified
- Aug 2010
- First submitted
- 18 Jul 2010
- Last updated
- 11 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Epidemic Keratoconjunctivitis With 2% Povidone-iodine
- ClinicalTrials.gov ID
- NCT01179412
- Acronym / sponsor ID
- EKC2004
- Conditions
- Viral Conjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Aug 2010 (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.
The purpose of this study is to determine the outcomes of treating epidemic keratoconjunctivitis with 2% povidone-iodine.
Detailed description
The study design was a prospective interventional case series. Our institutional ethical committee approved the study protocol in April 2004. We performed this study between July 2004 and December 2009. During this period, there were 2 episodes of EKC epidemic. The first episode was in 2006 and the second in 2009.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2% povidone-iodine | Experimental | Drug: 2% povidone-iodine |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients who were diagnosed with EKC at the outpatient ophthalmic unit
Key exclusion criteria (5 listed)
- children younger than six years
- women being pregnant or during lactation
- history of allergy to povidone-iodine
- prior ocular surgery
- contact lens usage and chronic eye diseases with current eye medications.
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 |
|---|---|---|
| 2% povidone-iodineAlso: PVP-Iapply 4 times a day for one week | Drug | 2% povidone-iodine |
| 2% povidone-iodineAlso: PVP-Iapply 2% povidone-iodine 4 times per day for one week | Drug | 2% povidone-iodine |
Primary outcome
the recovery rate within one week of treatment
Time frame: 1 week
1 secondary outcome
drug tolerability
Time frame: 1 week
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 11 Aug 2010.
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.
Adisak Trinavarat, MD principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2% povidone-iodine in people with Viral Conjunctivitis, run by Mahidol University at 1 site in Thailand.
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 1 inclusion and 5 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 11 Aug 2010. 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 Thailand. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
the recovery rate within one week of treatment (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2010.