A study testing whether a single eye drop of iodine can help patients recover faster from viral conjunctivitis
| ISRCTN | ISRCTN23258214 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23258214 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Al Karkh General Hospital |
| Funder | Investigator initiated and funded |
- Submission date
- 14/10/2025
- Registration date
- 16/10/2025
- Last edited
- 16/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Viral conjunctivitis is a common eye infection, often caused by adenovirus. It usually clears up on its own but can cause discomfort and spread quickly in the community. At present, there is no approved medicine that shortens recovery time. This study aims to test whether a single application of povidone-iodine (an antiseptic eye drop) can help patients recover faster compared with usual supportive care.
Who can participate?
Patients aged 14 years and above who came to the hospital within 3 days of developing red, painful eyes, swelling of the eyelids, discharge, or other typical signs of viral conjunctivitis.
What does the study involve?
Participants were randomly divided into two groups. One group received standard treatment (artificial tears and hygiene advice). The other group received the same treatment plus a single 5% povidone-iodine eye drop. Both groups were followed up on days 3, 7, 10, 14 and 21 to check improvement of symptoms and any side effects.
What are the possible benefits and risks of participating?
The possible benefit is a quicker recovery from viral conjunctivitis and reduced spread of infection. The treatment is generally safe and well-tolerated. The possible risks are mild eye irritation, which is temporary and not harmful.
Where is the study run from?
The study was carried out at Al-Kharkh General Hospital, Baghdad, Iraq.
When is the study starting and how long is it expected to run for?
The study began in February 2023 and ended in September 2023.
Who is funding the study?
The study was self-funded by the lead investigator.
Who is the main contact?
Dr. Rawan Ahmed Alatraqchi
Email: rawan.alatraqchi@gmail.com
Contact information
Public, Scientific, Principal investigator
Baghdad
Baghdad
10010
Iraq
| 0009-0000-6395-9858 | |
| Phone | +964 7713014217 |
| rawan.alatraqchi@cht.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A prospective randomized clinical trial comparing a single-dose 5% povidone-iodine eye drop plus supportive care versus supportive care alone in patients with adenoviral conjunctivitis |
| Study acronym | RAPID-I |
| Study objectives | To evaluate whether a single 5% povidone-iodine eye drop application shortens the recovery period and improves clinical outcomes in patients with adenoviral conjunctivitis compared to standard supportive care. |
| Ethics approval(s) |
Approved 16/01/2023, Local Research and Ethics Committee of Al Karkh General Hospital (Baghdad / Al Karkh, Baghdad, 10010, Iraq; +964 7713014217; naseeranaser84@gmail.com), ref: LREC/AKGH/2023/042 |
| Health condition(s) or problem(s) studied | Adenovirus conjunctivitis |
| Intervention | The trial investigated whether a single-dose application of povidone-iodine could shorten recovery time in adenoviral conjunctivitis. Intervention arm: Single application of 5% povidone-iodine ophthalmic solution to the affected eye(s) at the first visit, in addition to standard supportive care (artificial tears, cold compresses, hygiene advice). Control arm: Standard supportive care only, without povidone-iodine. Randomisation: Simple alternate allocation (non-blinded). Duration: Single-dose intervention; supportive treatment continued for 7–10 days as required. Follow-up: Clinical reviews on Day 3, Day 7, Day 10, and Day 14 (resolution of conjunctival hyperaemia, discharge, and follicular reaction). All patient data have been fully anonymised before sharing, with personal identifiers replaced by coded study IDs to maintain confidentiality. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 5% iodine |
| Primary outcome measure(s) |
Time to clinical recovery from adenoviral conjunctivitis (days), measured from day of intervention until complete resolution of conjunctival congestion, tearing and discharge, assessed by slit-lamp examination and patient-reported symptoms |
| Key secondary outcome measure(s) |
1. Change in symptom severity score (redness, tearing, foreign body sensation, discharge) measured using a standardized clinical grading scale at baseline, day 3, day 7, and day 14 |
| Completion date | 01/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 14 Years |
| Sex | All |
| Target sample size at registration | 66 |
| Total final enrolment | 66 |
| Key inclusion criteria | 1. Aged over 14 years 2. Presented within 3 days of symptoms and signs of ocular infection which included: redness, pain, lid swelling, mucopurulent discharge, lymphadenopathy and follicular reaction |
| Key exclusion criteria | 1. Age under 14 years 2. Onset of symptoms more than 3 days before presentation 3. Any ocular treatment received before presentation 4. Patients with existing ocular diseases |
| Date of first enrolment | 01/02/2023 |
| Date of final enrolment | 01/09/2023 |
Locations
Countries of recruitment
- Iraq
Study participating centre
Baghdad
10011
Iraq
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated and/or analysed during this study will be available upon reasonable request from the corresponding author. Contact: Dr. Rawan Ahmed Alatraqchi (rawan.alatraqchi@gmail.com) Type of data: De-identified participant-level clinical data (age, sex, symptoms, treatment group, outcome measures). When available: From the date of publication of the main results and for up to 5 years thereafter. Access criteria: Researchers with a methodologically sound proposal may request access. Data will be shared in anonymised form to protect participant confidentiality. Restrictions: No personal identifiers will be shared. Ethical approval and participant consent included data use for research purposes. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Dataset | xlsx | 16/10/2025 | No | No |
Additional files
Editorial Notes
16/10/2025: Trial's existence confirmed by Local Research and Ethics Committee of Al Karkh General Hospital.