Dry Eye SyndromesNCT03706443
Tear Lipid Layer Thickness Changes With Use of Emollient and Non-Emollient Eye Drops
A study testing Systane Complete and Systane Ultra in people with Dry Eye Syndromes and Keratoconjunctivitis Sicca, run by Ohio State University at 1 site in United States.
Trial summary
Cross-over comparison of lipid layer thickness and dry eye symptoms with two artificial tear formulations. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes, Keratoconjunctivitis Sicca, Lacrimal Apparatus Diseases
- What is being tested?
- Systane Complete and Systane Ultra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2018to 28 Feb 2019
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age - at least 30 years
- Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI)
- Ability to give informed consent
- Willing to spend time for the study; approximately one hour for a screening visit and two eye drop exposure visits lasting approximately 6 hours each. Part 2 of the study will include using an eye drop of Systane® Complete 4x/day for 1 month and returning for one visit lasting approximately 1 hour.
- Either gender
- Any racial or ethnic origin
- SVCM tear lipid thickness ≤ 75 nm
- Contact lens wearers must refrain from lens wear for two days before the screening visit, including the day of the baseline visit, and during the entire study.
Who cannot join
- Use of any ocular prescription medication (such as but not limited to, glaucoma medications, anti-inflammatory eye drops and Restasis) used within 14 days of the screening visit or started prior to the measurement visit(s).
- Currently having punctal plugs inserted in lacrimal puncta
- Current eye disease, infection or inflammation that affects the surface of the eye such as, but not limited to moderate or greater blepharitis and ocular allergy. Clinically significant (active treatment) of blepharitis, Sjogren's disease or other systemic disease that could influence MGD, corneal, conjunctival, or eyelid abnormalities that could influence lipid layer thickness, conjunctivitis of any cause, ocular infection or systemic medication such as diuretics, SSRIs, that could influence tear secretion, or sensitivity to any of the ingredient in the eye drop being tested,
- Past eye surgery, such as, but not limited to, refractive surgery. Subjects who have had cataract removal surgery more than one year ago may be considered as potential subjects.
- Female subjects may not be pregnant or lactating. (Subject will be asked to self report these conditions.)
- Infectious diseases (for example, hepatitis, tuberculosis) or an immuno-suppressive disease (for example, HIV). (Subjects will be asked to self-report these conditions.)
- Inability to complete the screening and examination
- Inability to provide analyzable data. For example, subjects who cannot keep their eye open during the entire measurement interval (due to early blinking) or provide a readable eye image (due to eyelid laxity) or cannot sit still for 1 minute.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Optometry
Columbus, Ohio, 43210
About this study
Cross-over comparison of lipid layer thickness and dry eye symptoms with two artificial tear formulations.
Read the detailed description
This study will objectively evaluate two US lubricant eye drop formulations produced by Alcon, INC. Systane® Ultra, a non-emollient eye drop, will be compared to Systane® Complete, an emollient eye drop, in subjects with dry eye symptoms and lipid layer thickness < 75 nm at baseline in a randomized, cross-over (masked subject) design. We seek to objectively evaluate the increase in lipid layer thickness from baseline at 15 minutes and 1, 2, 4 and 6 hours after each eye drop has been instilled. Non-invasive measurements of tear break-up time will be also conducted at each visit. Subjects will then be dispensed the emollient eye drop (Systane® Complete) for use four times daily for one month and return to the study site for final measurements of dry eye symptoms, lipid layer thickness, and tear break-up time. The Stroboscopic Video Color Microscope of King-Smith is used for non-invasive lipid layer thickness measurement, and the Oculus Keratograph (K5M) is used for non-invasive measurements of tear break-up time.
- Conditions
- Dry Eye Syndromes, Keratoconjunctivitis Sicca, Lacrimal Apparatus Diseases, Keratoconjunctivitis, Eye Diseases, Keratitis
- Being tested
- Systane Complete, Systane Ultra
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis Sicca, Lacrimal Apparatus Diseases, Keratoconjunctivitis, Eye Diseases, Keratitis, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systane CompleteOther
Lubricant eye drop which is based on propylene glycol 0.6%. Used for temporary relief of burning and irritation due to dryness of the eye.
Systane UltraOther
Lubricant eye drop which is based on polyethylene glycol 400 0.4% and propylene glycol 0.3%. Used for temporary relief of burning and irritation due to dryness of the eye.
| Study group | Role | What they receive |
|---|---|---|
| Systane® Complete | Active comparator | All subjects are randomly assigned to arm one or arm two. Subjects are assigned to be treated with one drop of Systane® Complete, and the tear lipid layer thickness is to be measured at 15 minutes, 1, 2, 4, and 6 hours after instillation of the eye drop. Following a minimum of a 2-day washout, the same subjects will proceed to the second arm. Receives: Other: Systane Complete |
| Systane® Ultra | Active comparator | All subjects are randomly assigned to arm one or arm two. Subjects are assigned to be treated with one drop of Systane® Ultra, and the tear lipid layer thickness is to be measured at 15 minutes, 1, 2, 4, and 6 hours after instillation of the eye drop. Following a minimum of a 2-day washout, the same subjects will proceed to the second arm. Receives: Other: Systane Ultra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Lipid Layer Thickness
Interference microscopy
Measured: 1 minute
Secondary outcomes (1)
Tear Break-Up Time
Oculus Keratograph (K5M)
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start5 Dec 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single masked; randomized
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Principal investigator, Jennifer Fogt, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706443
- Sponsor's protocol ID
- 2018H0433
- Status last verified
- May 2019
- First submitted
- 11 Oct 2018
- Last updated
- 23 May 2019
- Results posted
- 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 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tear Lipid Layer Thickness Changes With Use of Emollient and Non-Emollient Eye Drops
- ClinicalTrials.gov ID
- NCT03706443
- Acronym / sponsor ID
- 2018H0433
- Conditions
- Dry Eye Syndromes, Keratoconjunctivitis Sicca, Lacrimal Apparatus Diseases, Keratoconjunctivitis, Eye Diseases, Keratitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 16 Oct 2018 (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.
Cross-over comparison of lipid layer thickness and dry eye symptoms with two artificial tear formulations.
Detailed description
This study will objectively evaluate two US lubricant eye drop formulations produced by Alcon, INC. Systane® Ultra, a non-emollient eye drop, will be compared to Systane® Complete, an emollient eye drop, in subjects with dry eye symptoms and lipid layer thickness < 75 nm at baseline in a randomized, cross-over (masked subject) design. We seek to objectively evaluate the increase in lipid layer thickness from baseline at 15 minutes and 1, 2, 4 and 6 hours after each eye drop has been instilled. Non-invasive measurements of tear break-up time will be also conducted at each visit. Subjects will then be dispensed the emollient eye drop (Systane® Complete) for use four times daily for one month and return to the study site for final measurements of dry eye symptoms, lipid layer thickness, and tear break-up time. The Stroboscopic Video Color Microscope of King-Smith is used for non-invasive lipid layer thickness measurement, and the Oculus Keratograph (K5M) is used for non-invasive measurements of tear break-up time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single masked; randomized
| Arm | Type | Receives |
|---|---|---|
| Systane® Complete | Active comparator | Other: Systane CompleteAll subjects are randomly assigned to arm one or arm two. Subjects are assigned to be treated with one drop of Systane® Complete, and the tear lipid layer thickness is to be measured at 15 minutes, 1, 2, 4, and 6 hours after instillation of the eye drop. Following a minimum of a 2-day washout, the same subjects will proceed to the second arm. |
| Systane® Ultra | Active comparator | Other: Systane UltraAll subjects are randomly assigned to arm one or arm two. Subjects are assigned to be treated with one drop of Systane® Ultra, and the tear lipid layer thickness is to be measured at 15 minutes, 1, 2, 4, and 6 hours after instillation of the eye drop. Following a minimum of a 2-day washout, the same subjects will proceed to the second arm. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age - at least 30 years
- Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI)
- Ability to give informed consent
- Willing to spend time for the study; approximately one hour for a screening visit and two eye drop exposure visits lasting approximately 6 hours each. Part 2 of the study will include using an eye drop of Systane® Complete 4x/day for 1 month and returning for one visit lasting approximately 1 hour.
- Either gender
Key exclusion criteria (8 listed)
- Use of any ocular prescription medication (such as but not limited to, glaucoma medications, anti-inflammatory eye drops and Restasis) used within 14 days of the screening visit or started prior to the measurement visit(s).
- Currently having punctal plugs inserted in lacrimal puncta
- Current eye disease, infection or inflammation that affects the surface of the eye such as, but not limited to moderate or greater blepharitis and ocular allergy. Clinically significant (active treatment) of blepharitis, Sjogren's disease or other systemic disease that could influence MGD, corneal, conjunctival, or eyelid abnormalities that could influence lipid layer thickness, conjunctivitis of any cause, ocular infection or systemic medication such as diuretics, SSRIs, that could influence tear secretion, or sensitivity to any of the ingredient in the eye drop being tested,
- Past eye surgery, such as, but not limited to, refractive surgery. Subjects who have had cataract removal surgery more than one year ago may be considered as potential subjects.
- Female subjects may not be pregnant or lactating. (Subject will be asked to self report these conditions.)
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 |
|---|---|---|
| Systane CompleteLubricant eye drop which is based on propylene glycol 0.6%. Used for temporary relief of burning and irritation due to dryness of the eye. | Other | Systane® Complete |
| Systane UltraLubricant eye drop which is based on polyethylene glycol 400 0.4% and propylene glycol 0.3%. Used for temporary relief of burning and irritation due to dryness of the eye. | Other | Systane® Ultra |
Primary outcome
Tear Lipid Layer Thickness
Time frame: 1 minute
Interference microscopy
1 secondary outcome
Tear Break-Up Time
Time frame: 1 minute
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 23 May 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systane Complete and Systane Ultra in people with Dry Eye Syndromes and Keratoconjunctivitis Sicca, run by Ohio State 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 8 inclusion and 8 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 23 May 2019. 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.
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?
Tear Lipid Layer Thickness (time frame: 1 minute). 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 23 May 2019.