Dry Eye DiseaseNCT06058559
Effect of Sunflower Lecithin Supplementation on Meibomian Gland Function in Adults With Dry Eye Disease
A study testing Sunflower lecithin and Olive oil in people with Dry Eye Disease and Meibomian Gland Dysfunction, run by George Washington University at 1 site in United States.
Trial summary
This prospective study will evaluate the effect of oral sunflower lecithin dietary supplementation on meibomian gland function in adults with dry eye disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease, Meibomian Gland Dysfunction
- What is being tested?
- Sunflower lecithin and Olive oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2023to 26 Oct 2023
- Phase
- Interventional
- 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
- Age greater than18 at the time of informed consent
- Clinical diagnosis of dry eye in both eyes
- Fluorescein tear film break-up time (TBUT) less than 10s in both eyes
- The presence of lid margin scaling, telangiectasia, collarette or meibomian gland plugging on slit-lamp examination
- Best-corrected visual acuity (BCVA, Snellen) of 20/40 or better in each eye
- Patient Evaluation of Eye Dryness (SPEED) questionnaire score >6 to <14
- Must understand; be willing and able, and likely to fully comply with study procedures, visit schedule, and restrictions
Who cannot join
- Any pre-existing ocular disease other than dry eye disease
- Patients with inability to swallow soft gel capsules
- Severe illness, pregnancy or breastfeeding, smoking, and regular use of strongly anticholinergic drugs.
- Drastic change of food and/or food supplements within the last month.
- Other food supplement with fatty acids
- Evidence of acute ocular infection and⁄or intraocular inflammation within 1 month prior to the onset of this study.
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- Ocular surgery within the last 6 months.
- Patients treated with topical ocular, steroidal or non-steroidal, anti-inflammatory treatment within the last month.
- Occlusion therapy with lacrimal or punctum plugs within the last 3 months.
- Alterations of the lacrimal drainage system
- Eyelid abnormalities
- Patients on oral tetracycline or corticosteroids
- Active allergy or infection at the ocular surface
Trial locations and contacts
1 site in 1 country.
United States1 site
The GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
This prospective study will evaluate the effect of oral sunflower lecithin dietary supplementation on meibomian gland function in adults with dry eye disease.
Read the detailed description
Enrolled patients in the active arm of the study (n=20) will receive a daily dose of four sunflower lecithin 1,200 mg soft-gel capsules for a duration of 90 days. Patients in the control arm (n=10) will receive four doses of a 1,000 mg placebo soft-gel capsules (containing olive oil). Patients will be evaluated for meibomian gland function and signs and symptoms of dry eye at baseline and at the end of the study using a standardized eye dryness survey (SPEED survey), Tear Breakup Time Measurement, Meibomian Gland Score, and a rapid in-office assessment of years (InflammaDry).
- Conditions
- Dry Eye Disease, Meibomian Gland Dysfunction
- Being tested
- Sunflower lecithin, Olive oil
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunflower lecithinDietary supplement
Lecithins are a group of essential phospholipids that are involved in a number of biological functions such as lipid-cholesterol transport, transmembrane signaling, and neurological function
Olive oilDietary supplement
Extra virgin olive oil
| Study group | Role | What they receive |
|---|---|---|
| Sunflower Lecithin | Experimental | Total 4800 mg sunflower lecithin per day taken in 4 softgel capsules Receives: Dietary Supplement: Sunflower lecithin |
| Olive Oil | Placebo comparator | Total 4000 mg olive oil per day taken in 4 softgel capsules Receives: Dietary Supplement: Olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of the SPEED questionnaire score at Day 90
To assess the improvement of dry eye symptoms by SPEED questionnaire. 0 score is the minimum (no dry eye symptom); 64 is the maximum score (most symptomatic). Change = (Day 90 score - Baseline score)
Measured: 90 days
Secondary outcomes (3)
Change from Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 90
Fluorescein Tear Break-Up Time (TBUT) is a measurement in seconds of tear film stability. The shorter the TBUT, the lower the tear film stability. Lower tear film stability is associated with dry eye. Change = (Day 90 value - Baseline value)
Measured: 90 days
Change in number of MMP-positive eyes at Day 90
InflammaDry is a noninvasive immunoassay for detecting the presence of MMP-9 in tears.
Measured: 90 days
Least Squares Mean Change from Baseline in Meibomian Gland Score (MGS) at Day 90
Meibomian glands on the eyelids assessed by the examiner using a Meibomian Gland Evaluator (MGE) and a slit lamp microscope. An MGE instrument applies a standardized force simulating the pressure of a deliberate blink allowing eye care professionals to observe meibomian gland functionality through a slit lamp. 5 glands in 1 zone (nasal) evaluated for each eye and scored from 0 to 3, with a resultant overall score (MGS) of 0 to 15 for each eye. Scoring as follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best). A higher change from baseline score indicates an improvement in meibomian gland function.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start20 Jun 2023
- Primary completion26 Oct 2023
- Study completion26 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- More trials run by George Washington 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Lions Institute Foundation
- Responsible party
- Sponsor
- Investigators
- David Belyea, MD, Study chair, The George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058559
- Sponsor's protocol ID
- 101
- Status last verified
- Mar 2024
- First submitted
- 22 Sep 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sunflower Lecithin Supplementation on Meibomian Gland Function in Adults With Dry Eye Disease
- ClinicalTrials.gov ID
- NCT06058559
- Acronym / sponsor ID
- 101
- Conditions
- Dry Eye Disease, Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- Virginia Lions Institute Foundation
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 26 Oct 2023 (actual)
- Study completion
- 26 Oct 2023 (actual)
- First posted
- 28 Sep 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 prospective study will evaluate the effect of oral sunflower lecithin dietary supplementation on meibomian gland function in adults with dry eye disease.
Detailed description
Enrolled patients in the active arm of the study (n=20) will receive a daily dose of four sunflower lecithin 1,200 mg soft-gel capsules for a duration of 90 days. Patients in the control arm (n=10) will receive four doses of a 1,000 mg placebo soft-gel capsules (containing olive oil). Patients will be evaluated for meibomian gland function and signs and symptoms of dry eye at baseline and at the end of the study using a standardized eye dryness survey (SPEED survey), Tear Breakup Time Measurement, Meibomian Gland Score, and a rapid in-office assessment of years (InflammaDry).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sunflower Lecithin | Experimental | Dietary Supplement: Sunflower lecithinTotal 4800 mg sunflower lecithin per day taken in 4 softgel capsules |
| Olive Oil | Placebo comparator | Dietary Supplement: Olive oilTotal 4000 mg olive oil per day taken in 4 softgel capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age greater than18 at the time of informed consent
- Clinical diagnosis of dry eye in both eyes
- Fluorescein tear film break-up time (TBUT) less than 10s in both eyes
- The presence of lid margin scaling, telangiectasia, collarette or meibomian gland plugging on slit-lamp examination
- Best-corrected visual acuity (BCVA, Snellen) of 20/40 or better in each eye
Key exclusion criteria (13 listed)
- Any pre-existing ocular disease other than dry eye disease
- Patients with inability to swallow soft gel capsules
- Severe illness, pregnancy or breastfeeding, smoking, and regular use of strongly anticholinergic drugs.
- Drastic change of food and/or food supplements within the last month.
- Other food supplement with fatty acids
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 |
|---|---|---|
| Sunflower lecithinLecithins are a group of essential phospholipids that are involved in a number of biological functions such as lipid-cholesterol transport, transmembrane signaling, and neurological function | Dietary supplement | Sunflower Lecithin |
| Olive oilExtra virgin olive oil | Dietary supplement | Olive Oil |
Primary outcome
Change from Baseline of the SPEED questionnaire score at Day 90
Time frame: 90 days
To assess the improvement of dry eye symptoms by SPEED questionnaire. 0 score is the minimum (no dry eye symptom); 64 is the maximum score (most symptomatic). Change = (Day 90 score - Baseline score)
3 secondary outcomes
Change from Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 90
Time frame: 90 days
Change in number of MMP-positive eyes at Day 90
Time frame: 90 days
Least Squares Mean Change from Baseline in Meibomian Gland Score (MGS) at Day 90
Time frame: 90 days
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 15 Mar 2024.
- 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.
David Belyea, MD study chair
The George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sunflower lecithin and Olive oil in people with Dry Eye Disease and Meibomian Gland Dysfunction, run by George Washington 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 7 inclusion and 13 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 15 Mar 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change from Baseline of the SPEED questionnaire score at Day 90 (time frame: 90 days). 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 15 Mar 2024.