Disinfectant Causing Toxic EffectEarly Phase 1NCT03957291
Chlorohexidine Versus Povidone Iodine as Apreoperative Ophthalmic Disinfectant
A Early Phase 1 study testing Chlorhexidine and Povidone-Iodine in people with Disinfectant Causing Toxic Effect, run by Assiut University.
Trial summary
1. Is to assess the efficacy of preoperative disinfection with chlorohexidine and povidone iodine in different concentrations separately . 2. Is to compare the efficacy of chlorohexidine to povidone iodine. 3. Compare patient comfort after instillation of each disinfectant . 4. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Disinfectant Causing Toxic Effect
- What is being tested?
- Chlorhexidine and Povidone-Iodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Dec 2022
- Phase
- Early Phase 1
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Current patient of the Assiute University Hospital arranged for ophthamic surgery
- Age greater than 12.
Who cannot join
- Documented allergy to PI or AC
- Current diagnosis of infectious keratitis
- History of unilateral contact lens wear in the past 30 days
- Current unilateral use of prescription eye drops.
Trial locations and contacts
No sites are listed yet.
About this study
- Is to assess the efficacy of preoperative disinfection with chlorohexidine and povidone iodine in different concentrations separately .
- Is to compare the efficacy of chlorohexidine to povidone iodine.
- Compare patient comfort after instillation of each disinfectant .
- To find which disinfectant is more effective tolerated and more safe for use .
Read the detailed description
Methods: This is a single center prospective study comparing antiseptic efficacy and ocular surface irritation with PI (povidine iodine) and AC (aqueous chlorhexidine). . Prior to sugery patients who meet inclusion criteria will be identified and informed consent will be obtained. Study personnel will obtain two samples one from conjunctival sac and th other from skin around the eye. Topical antisepsis will then be applied, the first eye will be randomized to one drop of either PI 5% - 2.5% or AC 0.1%- 0.05% and the second eye will receive the other agent. One minute after instillation of the eye drop to each eye, patients will rate their pain in each eye using the Wong-Baker (smiley face) rating scale. After 15 minutes the second swabs will be taken in the same manner as the first swabs. . On post-operative day three, study personnel will meet the patient and ask to rate the pain in each eye using the same verbal numerical rating scale and to perform slit lamb examination for any complication.
- Conditions
- Disinfectant Causing Toxic Effect
- Being tested
- Chlorhexidine, Povidone-Iodine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineDrug
Also called aqueous Chlorhexidine
chlorhexidine administration prior to ophthalmic surgery (compared to Povidine iodine )
Povidone-IodineDrug
Also called betadine
Povidine iodine administration prior to ophthalmic surgery (compared to chlorhexidine)
| Study group | Role | What they receive |
|---|---|---|
| Povidine-Iodine | Active comparator | patients receiving Povidine-Iodine in right eye, chlorhexidine in the left eye before operation Receives: Drug: Povidone-Iodine |
| chlorhexidine | Active comparator | patients receiving Povidine-Iodine in left eye, chlorhexidine in the right eye before operation Receives: Drug: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Comfort
Patient Comfort using the Wong Baker FACES Pain Scale [Scale: 0(No pain) - 10 (Worst Pain)]
Measured: day three post operative
Secondary outcomes (2)
Culture of conjunctiva for bacteria
Microbial flora in conjunctival swab
Measured: 7 days
Patient Comfort
Patient Comfort using the Wong Baker FACES Pain Scale [Scale: 0(No pain) - 10 (Worst Pain)]
Measured: I minute after disinfectant drop instilled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study startAug 2019 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disinfectant Causing Toxic EffectStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized prospective trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa mohammed mostafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957291
- Sponsor's protocol ID
- CHG vs PI in ophthalmology
- Status last verified
- May 2019
- First submitted
- 18 May 2019
- Last updated
- 21 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grzybowski A, Kanclerz P, Myers WG. The use of povidone-iodine in ophthalmology. Curr Opin Ophthalmol. 2018 Jan;29(1):19-32. doi: 10.1097/ICU.0000000000000437.
PubMed 28984794
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlorohexidine Versus Povidone Iodine as Apreoperative Ophthalmic Disinfectant
- ClinicalTrials.gov ID
- NCT03957291
- Acronym / sponsor ID
- CHG vs PI in ophthalmology
- Conditions
- Disinfectant Causing Toxic Effect
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 May 2019 (actual)
- 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.
- Is to assess the efficacy of preoperative disinfection with chlorohexidine and povidone iodine in different concentrations separately .
- Is to compare the efficacy of chlorohexidine to povidone iodine.
- Compare patient comfort after instillation of each disinfectant .
- To find which disinfectant is more effective tolerated and more safe for use .
Detailed description
Methods: This is a single center prospective study comparing antiseptic efficacy and ocular surface irritation with PI (povidine iodine) and AC (aqueous chlorhexidine). . Prior to sugery patients who meet inclusion criteria will be identified and informed consent will be obtained. Study personnel will obtain two samples one from conjunctival sac and th other from skin around the eye. Topical antisepsis will then be applied, the first eye will be randomized to one drop of either PI 5% - 2.5% or AC 0.1%- 0.05% and the second eye will receive the other agent. One minute after instillation of the eye drop to each eye, patients will rate their pain in each eye using the Wong-Baker (smiley face) rating scale. After 15 minutes the second swabs will be taken in the same manner as the first swabs. . On post-operative day three, study personnel will meet the patient and ask to rate the pain in each eye using the same verbal numerical rating scale and to perform slit lamb examination for any complication.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized prospective trial
| Arm | Type | Receives |
|---|---|---|
| Povidine-Iodine | Active comparator | Drug: Povidone-Iodinepatients receiving Povidine-Iodine in right eye, chlorhexidine in the left eye before operation |
| chlorhexidine | Active comparator | Drug: Chlorhexidinepatients receiving Povidine-Iodine in left eye, chlorhexidine in the right eye before operation |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Current patient of the Assiute University Hospital arranged for ophthamic surgery
- Age greater than 12.
Key exclusion criteria (4 listed)
- Documented allergy to PI or AC
- Current diagnosis of infectious keratitis
- History of unilateral contact lens wear in the past 30 days
- Current unilateral use of prescription eye drops.
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 |
|---|---|---|
| ChlorhexidineAlso: aqueous Chlorhexidinechlorhexidine administration prior to ophthalmic surgery (compared to Povidine iodine ) | Drug | chlorhexidine |
| Povidone-IodineAlso: betadinePovidine iodine administration prior to ophthalmic surgery (compared to chlorhexidine) | Drug | Povidine-Iodine |
Primary outcome
Patient Comfort
Time frame: day three post operative
Patient Comfort using the Wong Baker FACES Pain Scale [Scale: 0(No pain) - 10 (Worst Pain)]
2 secondary outcomes
Culture of conjunctiva for bacteria
Time frame: 7 days
Patient Comfort
Time frame: I minute after disinfectant drop instilled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Background: PubMed 28984794Grzybowski A, Kanclerz P, Myers WG. The use of povidone-iodine in ophthalmology. Curr Opin Ophthalmol. 2018 Jan;29(1):19-32. doi: 10.1097/ICU.0000000000000437.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Chlorhexidine and Povidone-Iodine in people with Disinfectant Causing Toxic Effect, run by Assiut University.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact asmaa mohamed, master (01094109699 ext. 01065637228, am650124@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Comfort (time frame: day three post operative). 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 NCT03957291, which also lists 1 linked publication.
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 21 May 2019.