CataractPhase 3NCT04568213
Hypochlorous Acid Disinfection Prior to Cataract Surgery
A Phase 3 study testing Hypochlorous Acid Gel 0.02% in people with Cataract and Endophthalmitis, run by Loma Linda University at 1 site in United States.
Trial summary
Antibiotics are commonly utilized to reduce the bacterial population of the eye prior to surgery with the assumption that this reduces the risk of endophthalmitis, although it is not clear if this actually occurs. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Cataract, Endophthalmitis
- What is being tested?
- Hypochlorous Acid Gel 0.02%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2020to 9 Dec 2022
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing cataract surgery.
Who cannot join
- Age <18 years old
- Vulnerable subjects
- Non-English Speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Health
Loma Linda, California, 92354
About this study
Official title: Effect of Hypochlorous Acid Disinfection on Ocular Flora Prior to Cataract Surgery
Antibiotics are commonly utilized to reduce the bacterial population of the eye prior to surgery with the assumption that this reduces the risk of endophthalmitis, although it is not clear if this actually occurs. This study will investigate the use of Hypochlorous Acid, a commercially available over the counter (OTC) medication to see if this will reduce the bacterial population prior the cataract surgery.
- Conditions
- Cataract, Endophthalmitis
- Being tested
- Hypochlorous Acid Gel 0.02%
- Keywords
- Ocular/Eyelid Flora
- Medical subject headings
- Cataract, Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypochlorous Acid Gel 0.02%Drug
0.02% Hypochlorous Acid Gel (OCusoft Hypochlor GEL) will be sprayed onto the closed eyelid of the surgical eye while covering the fellow eye with palm of the hand, left for 60 seconds, then wiped off with a clean gauze, tissue, or cotton ball.
| Study group | Role | What they receive |
|---|---|---|
| Hypochlorous Gel Application | Experimental | Not described Receives: Drug: Hypochlorous Acid Gel 0.02% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in bacterial flora in eyelashes of treatment eye compared to fellow eye
Swab will be used to obtain samples from the eyelashes bilaterally and cultured
Measured: On day of surgery prior to surgical prep
Reduction in bacterial flora in conjunctiva of treatment eye compared to fellow
Swab will be used to obtain samples from the conjunctiva bilaterally and cultured
Measured: On day of surgery prior to surgical prep
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start29 Oct 2020
- Primary completion9 Dec 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Loma Linda 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey J Ing, MD, Principal investigator, Loma Linda University Department of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568213
- Sponsor's protocol ID
- 5200306
- Status last verified
- Feb 2023
- First submitted
- 24 Sep 2020
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hypochlorous Acid Disinfection on Ocular Flora Prior to Cataract Surgery
- ClinicalTrials.gov ID
- NCT04568213
- Acronym / sponsor ID
- 5200306
- Conditions
- Cataract, Endophthalmitis
- Keywords
- Ocular/Eyelid Flora
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 9 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 29 Sep 2020 (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.
Antibiotics are commonly utilized to reduce the bacterial population of the eye prior to surgery with the assumption that this reduces the risk of endophthalmitis, although it is not clear if this actually occurs. This study will investigate the use of Hypochlorous Acid, a commercially available over the counter (OTC) medication to see if this will reduce the bacterial population prior the cataract surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypochlorous Gel Application | Experimental | Drug: Hypochlorous Acid Gel 0.02% |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing cataract surgery.
Key exclusion criteria (3 listed)
- Age <18 years old
- Vulnerable subjects
- Non-English Speakers
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 |
|---|---|---|
| Hypochlorous Acid Gel 0.02%0.02% Hypochlorous Acid Gel (OCusoft Hypochlor GEL) will be sprayed onto the closed eyelid of the surgical eye while covering the fellow eye with palm of the hand, left for 60 seconds, then wiped off with a clean gauze, tissue, or cotton ball. | Drug | Hypochlorous Gel Application |
Primary outcome
Reduction in bacterial flora in eyelashes of treatment eye compared to fellow eye
Time frame: On day of surgery prior to surgical prep
Swab will be used to obtain samples from the eyelashes bilaterally and cultured
Reduction in bacterial flora in conjunctiva of treatment eye compared to fellow
Time frame: On day of surgery prior to surgical prep
Swab will be used to obtain samples from the conjunctiva bilaterally and cultured
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 21 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Jeffrey J Ing, MD principal investigator
Loma Linda University Department of Ophthalmology
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 Hypochlorous Acid Gel 0.02% in people with Cataract and Endophthalmitis, run by Loma Linda University at 1 site in United States.
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 3 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 21 Feb 2023. 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 United States. 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 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?
Reduction in bacterial flora in eyelashes of treatment eye compared to fellow eye (time frame: On day of surgery prior to surgical prep). The study lists 2 primary outcomes in all. 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 21 Feb 2023.