Dry EyePhase 4NCT05990712
The Effect of a Pre-cataract Surgical Ocular Hygiene Regime on Microbial Load, Tear Osmolarity, Dry Eye, and Inflammatory Markers
A Phase 4 study testing Omega-3, Trehalose and Zocular Eyelid System Treatment in people with Dry Eye and Dry Eye Syndromes, run by Uptown Eye Specialists at 1 site in Canada.
Trial summary
This study assesses the impact of two differing ocular hygiene regimens prior to cataract surgery. The first regimen includes an omega-3 supplement and the second without, and both include an at-home lid wipe and cleansing eye drops. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Dry Eye Syndromes, Cataract
- What is being tested?
- Omega-3, Trehalose and Zocular Eyelid System Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2023to 1 Jan 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 or older who underwent cataract surgical ocular hygiene treatment regimen prior to cataract surgery.
- Patients of all severity of dry eye will be included.
Who cannot join
- Patients with any other ocular comorbidities (glaucoma, iritis, traumatic eye injury, known systemic autoimmune diseases, immune disorders, anti-inflammatory medications, blood disorders (eg. altered white counts), prior surgery, prior traumatic eye injury, previous dry eye interventions such as ocular plugs, radiofrequency, and IPL).
- Patients who have any complications arise during the cataract surgery.
- Patients with altered mental state and cannot provide informed consent.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Uptown Eye
Brampton, Ontario, L6Y 0P6
Sohel Somani, MD, sohel.somani@uptowneye.ca
About this study
Official title: A Prospective Study on the Effect of Pre-cataract Surgical Ocular Hygiene Regime on Microbial Load, Tear Osmolarity, Dry Eye, and Inflammatory Markers Between Two Ocular Hygiene Regimen Groups
This study assesses the impact of two differing ocular hygiene regimens prior to cataract surgery. The first regimen includes an omega-3 supplement and the second without, and both include an at-home lid wipe and cleansing eye drops. These regimens will be assessed on microbial load, inflammation, tear osmolarity, and dry eye metrics. Patients will be randomized to either the omega-3 group + 3-part hygiene regimen, or the group with only the 3-part hygiene regimen. Data will be collected for inflammation through a test (InflammaDry) that measures an inflammatory marker, dry eye metrics via an imaging tool called Oculus 5M and the Canadian Dry Eye Assessment (CDEA) questionnaire, tear osmolarity through Tear Labs device, and area of growth for conjunctiva microbial load by swabbing the conjunctiva of the eye. Dry eye metrics (CDEA and Oculus 5M) will be collected during the patient's baseline appointment, 2-5 days prior to surgery, and post-operative month 1. Microbial load swabs will be collected at baseline, 2-5 days prior to surgery, and date of the surgery. An ocular assessment will also be completed at baseline, one week post-operation, and one month post-operation. All metrics will be compared to the fellow eye. The usage of omega-3 will be compared to the regimen without omega-3.
Read the detailed description
Prospective interventional study assessing the impact of two ocular hygiene regimens, with and without Omega-3, on microbial load, inflammation, tear osmolarity, and dry eye metrics and disease for patients soon to undergo cataract surgery. Study recruitment will occur at Uptown Eye between Sept-Nov 2023, with a target of 68 patients enrolled in the study. Patients will be consecutively randomized to group 1 (without omega 3 group) or group 2 (with omega 3 group). The intervention includes Zocular in clinic at baseline, Thealoz Duo eyedrops twice daily until surgery, and the cleansing wipes twice daily until surgery. The omega 3 group will take the supplement from baseline until one month post-operative.
Data will be collected for inflammation through a InflammaDry Matrix metallopeptidase 9 (MMP-9) test, dry eye through Oculus 5M (measures non-invasive break-up time (NIBUT), lipid layer, bulbar redness, tear meniscus height) and Canadian Dry Eye Assessment (CDEA), TearLab for osmolarity, and conjunctival swabs for microbial load. Dry eye metrics (CDEA and Oculus 5M) will be collected during the patient's baseline Cataract Dry Eye Clinic (CDEC) appointment, 2-5 days prior to surgery, and post-operative month 1. Microbial load will be collected at baseline, 2-5 days prior to surgery, and date of the surgery. Tear osmolarity and inflammation markers will be collected at baseline, 2-5 days prior to surgery, and post-operative month. An ocular assessment will also be completed at baseline, one week post-operation, and post-operative month. All metrics will be compared to the fellow eye.
- Conditions
- Dry Eye, Dry Eye Syndromes, Cataract
- Being tested
- Omega-3, Trehalose, Zocular Eyelid System Treatment, Blephadex cleansing eyelid wipes
- Keywords
- Pre-operative, Ocular hygiene, Omega 3, Microbial load, Inflammation, Tear osmolarity
- Medical subject headings
- Dry Eye Syndromes, Cataract, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3Dietary supplement
Omega-3 is a fatty acid and there is evidence that the consumption of re-esterified oral omega-3 supplements over the course of 6 to 8 weeks aid in reducing inflammation, dry eye, and optimizing tear osmolarity. The oral omega-3 supplement taken daily.
TrehaloseDrug
Also called Thealoz Duo Drops
Eyedrops consisting of trehalose and sodium hyaluronate that lubricate and hydrate the eye to relieve dry eye.
Zocular Eyelid System TreatmentDrug
Also called ZEST
A lid cleaning and debridement system that consists of okra-based gel to relieve dry eye or inflammation. The gel is applied to the eyelid margin and lashes with a cotton swab.
Blephadex cleansing eyelid wipesOther
Eyelid cleansing wipes with tea tree oil and coconut that help reduce infection.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 | Experimental | Participants in this arm will take oral omega-3 supplement for 4 weeks pre-operatively and 4 weeks post-operatively. They will also receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home. Receives: Dietary Supplement: Omega-3; Drug: Trehalose; Drug: Zocular Eyelid System Treatment; Other: Blephadex cleansing eyelid wipes |
| No Omega-3 | Active comparator | Participants in this arm will not take oral omega-3 supplement. They will only receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home. Receives: Drug: Trehalose; Drug: Zocular Eyelid System Treatment; Other: Blephadex cleansing eyelid wipes |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMP-9
Level of MMP-9, an inflammatory marker reported as positive (level of MMP-9 > 40ng/mL) or negative (level of MMP-9 < 40ng/mL).
Measured: Baseline, 2-5 days prior to surgery, post-operative month 1
Microbial load
Area of microbial growth from conjunctival swab reported as percentage of dish coverage, incubated for 48 hours
Measured: Baseline, 2-5 days prior to surgery, surgery day
Tear osmolarity
Measure of salt concentration in tear reported as mOsm/L
Measured: Baseline, 2-5 days prior to surgery, surgery day
Secondary outcomes (5)
Non-invasive break-up time (NIBUT)
Non-invasive break-up time (NIBUT) is measured using the Oculus 5M and measured in seconds, with longer NIBUT representing better outcomes.
Measured: Baseline, 2-5 days prior to surgery, post-operative month 1
Lipid layer
Lipid layer is reported in nanometres with higher/thicker lipid layers representing a better outcome.
Measured: Baseline, 2-5 days prior to surgery, post-operative month 1
Bulbar redness
Bulbar redness is reported by a score from 0-4 with lower scores representing a better outcome.
Measured: Baseline, 2-5 days prior to surgery, post-operative month 1
Tear meniscus height
Tear meniscus height (TMH) is reported in millimetres, with increases in TMH representing a better outcome.
Measured: Baseline, 2-5 days prior to surgery, post-operative month 1
Canadian Dry Eye Assessment (CDEA) Questionnaire
12 item questionnaire for reporting of dry eye symptoms on a scale of 0-4. Total scores for the CDEA questionnaire range from 0 to 48 and are interpreted as no dry eye symptoms or normal (<5), mild dry eye symptoms (5-20), moderate dry eye symptoms (21-30), or severe dry eye symptoms (31-48).
Measured: Baseline, 2-5 days prior to surgery, post-operative month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be assigned to either the omega-3 group or no omega-3 group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uptown Eye Specialists
- Sponsor type
- University, hospital or other
- Collaborators
- William Osler Health System, Forsee Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05990712
- Sponsor's protocol ID
- UptownEye4
- Status last verified
- Aug 2023
- First submitted
- 31 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- 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 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Effect of Pre-cataract Surgical Ocular Hygiene Regime on Microbial Load, Tear Osmolarity, Dry Eye, and Inflammatory Markers Between Two Ocular Hygiene Regimen Groups
- ClinicalTrials.gov ID
- NCT05990712
- Acronym / sponsor ID
- UptownEye4
- Conditions
- Dry Eye, Dry Eye Syndromes, Cataract
- Keywords
- Pre-operative, Ocular hygiene, Omega 3, Microbial load, Inflammation, Tear osmolarity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Uptown Eye SpecialistsUniversity, hospital or other
- Collaborators
- William Osler Health System, Forsee Canada
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 14 Aug 2023 (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.
This study assesses the impact of two differing ocular hygiene regimens prior to cataract surgery. The first regimen includes an omega-3 supplement and the second without, and both include an at-home lid wipe and cleansing eye drops. These regimens will be assessed on microbial load, inflammation, tear osmolarity, and dry eye metrics. Patients will be randomized to either the omega-3 group + 3-part hygiene regimen, or the group with only the 3-part hygiene regimen. Data will be collected for inflammation through a test (InflammaDry) that measures an inflammatory marker, dry eye metrics via an imaging tool called Oculus 5M and the Canadian Dry Eye Assessment (CDEA) questionnaire, tear osmolarity through Tear Labs device, and area of growth for conjunctiva microbial load by swabbing the conjunctiva of the eye. Dry eye metrics (CDEA and Oculus 5M) will be collected during the patient's baseline appointment, 2-5 days prior to surgery, and post-operative month 1. Microbial load swabs will be collected at baseline, 2-5 days prior to surgery, and date of the surgery. An ocular assessment will also be completed at baseline, one week post-operation, and one month post-operation. All metrics will be compared to the fellow eye. The usage of omega-3 will be compared to the regimen without omega-3.
Detailed description
Prospective interventional study assessing the impact of two ocular hygiene regimens, with and without Omega-3, on microbial load, inflammation, tear osmolarity, and dry eye metrics and disease for patients soon to undergo cataract surgery. Study recruitment will occur at Uptown Eye between Sept-Nov 2023, with a target of 68 patients enrolled in the study. Patients will be consecutively randomized to group 1 (without omega 3 group) or group 2 (with omega 3 group). The intervention includes Zocular in clinic at baseline, Thealoz Duo eyedrops twice daily until surgery, and the cleansing wipes twice daily until surgery. The omega 3 group will take the supplement from baseline until one month post-operative.
Data will be collected for inflammation through a InflammaDry Matrix metallopeptidase 9 (MMP-9) test, dry eye through Oculus 5M (measures non-invasive break-up time (NIBUT), lipid layer, bulbar redness, tear meniscus height) and Canadian Dry Eye Assessment (CDEA), TearLab for osmolarity, and conjunctival swabs for microbial load. Dry eye metrics (CDEA and Oculus 5M) will be collected during the patient's baseline Cataract Dry Eye Clinic (CDEC) appointment, 2-5 days prior to surgery, and post-operative month 1. Microbial load will be collected at baseline, 2-5 days prior to surgery, and date of the surgery. Tear osmolarity and inflammation markers will be collected at baseline, 2-5 days prior to surgery, and post-operative month. An ocular assessment will also be completed at baseline, one week post-operation, and post-operative month. All metrics will be compared to the fellow eye.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be assigned to either the omega-3 group or no omega-3 group.
| Arm | Type | Receives |
|---|---|---|
| Omega-3 | Experimental | Dietary Supplement: Omega-3, Drug: Trehalose, Drug: Zocular Eyelid System Treatment, Other: Blephadex cleansing eyelid wipesParticipants in this arm will take oral omega-3 supplement for 4 weeks pre-operatively and 4 weeks post-operatively. They will also receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home. |
| No Omega-3 | Active comparator | Drug: Trehalose, Drug: Zocular Eyelid System Treatment, Other: Blephadex cleansing eyelid wipesParticipants in this arm will not take oral omega-3 supplement. They will only receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 or older who underwent cataract surgical ocular hygiene treatment regimen prior to cataract surgery.
- Patients of all severity of dry eye will be included.
Key exclusion criteria (3 listed)
- Patients with any other ocular comorbidities (glaucoma, iritis, traumatic eye injury, known systemic autoimmune diseases, immune disorders, anti-inflammatory medications, blood disorders (eg. altered white counts), prior surgery, prior traumatic eye injury, previous dry eye interventions such as ocular plugs, radiofrequency, and IPL).
- Patients who have any complications arise during the cataract surgery.
- Patients with altered mental state and cannot provide informed consent.
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 |
|---|---|---|
| Omega-3Omega-3 is a fatty acid and there is evidence that the consumption of re-esterified oral omega-3 supplements over the course of 6 to 8 weeks aid in reducing inflammation, dry eye, and optimizing tear osmolarity. The oral omega-3 supplement taken daily. | Dietary supplement | Omega-3 |
| TrehaloseAlso: Thealoz Duo DropsEyedrops consisting of trehalose and sodium hyaluronate that lubricate and hydrate the eye to relieve dry eye. | Drug | No Omega-3, Omega-3 |
| Zocular Eyelid System TreatmentAlso: ZESTA lid cleaning and debridement system that consists of okra-based gel to relieve dry eye or inflammation. The gel is applied to the eyelid margin and lashes with a cotton swab. | Drug | No Omega-3, Omega-3 |
| Blephadex cleansing eyelid wipesEyelid cleansing wipes with tea tree oil and coconut that help reduce infection. | Other | No Omega-3, Omega-3 |
Primary outcome
MMP-9
Time frame: Baseline, 2-5 days prior to surgery, post-operative month 1
Level of MMP-9, an inflammatory marker reported as positive (level of MMP-9 > 40ng/mL) or negative (level of MMP-9 < 40ng/mL).
Microbial load
Time frame: Baseline, 2-5 days prior to surgery, surgery day
Area of microbial growth from conjunctival swab reported as percentage of dish coverage, incubated for 48 hours
Tear osmolarity
Time frame: Baseline, 2-5 days prior to surgery, surgery day
Measure of salt concentration in tear reported as mOsm/L
5 secondary outcomes
Non-invasive break-up time (NIBUT)
Time frame: Baseline, 2-5 days prior to surgery, post-operative month 1
Lipid layer
Time frame: Baseline, 2-5 days prior to surgery, post-operative month 1
Bulbar redness
Time frame: Baseline, 2-5 days prior to surgery, post-operative month 1
Tear meniscus height
Time frame: Baseline, 2-5 days prior to surgery, post-operative month 1
Canadian Dry Eye Assessment (CDEA) Questionnaire
Time frame: Baseline, 2-5 days prior to surgery, post-operative month 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 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.
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 Omega-3, Trehalose and Zocular Eyelid System Treatment in people with Dry Eye and Dry Eye Syndromes, run by Uptown Eye Specialists at 1 site in Canada.
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 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: status not confirmed, as of the sponsor's last update on 14 Aug 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sohel Somani, MD (416-292-0330, sohel.somani@uptowneye.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMP-9 (time frame: Baseline, 2-5 days prior to surgery, post-operative month 1). The study lists 3 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 14 Aug 2023.