Dry Eye SyndromesPhase 4NCT03380624
Tear Lipid Layer Thickness With Emollient Eye Drops
A Phase 4 study testing Refresh Optive and Refresh Optive MEGA-3 in people with Dry Eye Syndromes, run by Ohio State University at 1 site in United States.
Trial summary
Crossover comparison of lipid layer thickness 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
- What is being tested?
- Refresh Optive and Refresh Optive MEGA-3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 30 Jun 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 additional 4 hours for the study assessments. Study assessment will be conducted over 2 visit days, approximately 1 1/2 hours per day.
- Either gender
- Any racial or ethnic origin
- Stroboscopic Video Color Microscope tear lipid thickness ≤ 75 nm
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 Meibomian Gland Dysfunction, corneal, conjunctival, or eyelid abnormalities that could influence lipid layer thickness, conjunctivitis of any cause, ocular infection or systemic medication such as diuretics or drugs 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, but less than 10 years 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.
About this study
Crossover comparison of lipid layer thickness with two artificial tear formulations
Read the detailed description
This study will objectively evaluate two US Monograph lubricant eyedrop formulations (Allergan, plc). Refresh Optive ADVANCED will be compared to an investigational formula with additional compendial ingredients (Refresh Optive MEGA 3) 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 hour after each eye drop has been instilled. The Stroboscopic Video Color Microscope of King-Smith is used for non-invasive lipid layer thickness measurement.
- Conditions
- Dry Eye Syndromes
- Being tested
- Refresh Optive, Refresh Optive MEGA-3
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Refresh OptiveDrug
Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose
Refresh Optive MEGA-3Drug
Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose and with flaxseed oil and trehalose
| Study group | Role | What they receive |
|---|---|---|
| Refresh Optive, then Refresh Optive MEGA-3 | Experimental | Participants first utilized one drop of Refresh Optive in each eye before taking lipid layer thickness measurements occurring at 15 minutes and 1 hour after instillation. After a washout period, they returned to repeat the testing using one drop of Refresh Optive MEGA-3 before taking lipid layer thickness measurements.
. Receives: Drug: Refresh Optive; Drug: Refresh Optive MEGA-3 |
| Refresh Optive MEGA-3, then Refresh Optive | Experimental | Participants first utilized one drop of Refresh Optive MEGA-3 in each eye before taking lipid layer thickness measurements occurring at 15 minutes and 1 hour after instillation. After a washout period, they returned to repeat the testing using one drop of Refresh Optive before taking lipid layer thickness measurements. Receives: Drug: Refresh Optive; Drug: Refresh Optive MEGA-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tear Lipid Layer Thickness
Change in tear lipid layer thickness
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start1 Mar 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double masked, randomized
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Jennifer Fogt, Ohio State University
- Investigators
- Jennifer Fogt, OD MS, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380624
- Sponsor's protocol ID
- 2016H0354
- Status last verified
- Jan 2021
- First submitted
- 5 Apr 2017
- Last updated
- 3 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tear Lipid Layer Thickness With Emollient Eye Drops
- ClinicalTrials.gov ID
- NCT03380624
- Acronym / sponsor ID
- 2016H0354
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 21 Dec 2017 (actual)
- Results
- Posted 3 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Crossover comparison of lipid layer thickness with two artificial tear formulations
Detailed description
This study will objectively evaluate two US Monograph lubricant eyedrop formulations (Allergan, plc). Refresh Optive ADVANCED will be compared to an investigational formula with additional compendial ingredients (Refresh Optive MEGA 3) 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 hour after each eye drop has been instilled. The Stroboscopic Video Color Microscope of King-Smith is used for non-invasive lipid layer thickness measurement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double masked, randomized
| Arm | Type | Receives |
|---|---|---|
| Refresh Optive, then Refresh Optive MEGA-3 | Experimental | Drug: Refresh Optive, Drug: Refresh Optive MEGA-3Participants first utilized one drop of Refresh Optive in each eye before taking lipid layer thickness measurements occurring at 15 minutes and 1 hour after instillation. After a washout period, they returned to repeat the testing using one drop of Refresh Optive MEGA-3 before taking lipid layer thickness measurements. . |
| Refresh Optive MEGA-3, then Refresh Optive | Experimental | Drug: Refresh Optive, Drug: Refresh Optive MEGA-3Participants first utilized one drop of Refresh Optive MEGA-3 in each eye before taking lipid layer thickness measurements occurring at 15 minutes and 1 hour after instillation. After a washout period, they returned to repeat the testing using one drop of Refresh Optive before taking lipid layer thickness measurements. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age - at least 30 years
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).
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 |
|---|---|---|
| Refresh OptiveLubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose | Drug | Refresh Optive MEGA-3, then Refresh Optive, Refresh Optive, then Refresh Optive MEGA-3 |
| Refresh Optive MEGA-3Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose and with flaxseed oil and trehalose | Drug | Refresh Optive MEGA-3, then Refresh Optive, Refresh Optive, then Refresh Optive MEGA-3 |
Primary outcome
Change in Tear Lipid Layer Thickness
Time frame: 15 minutes
Change in tear lipid layer thickness
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Sjögren's Syndrome
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.
Jennifer Fogt, OD MS principal investigator
Ohio State University
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 Refresh Optive and Refresh Optive MEGA-3 in people with Dry Eye Syndromes, 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 7 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 3 Feb 2021. 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 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?
Yes. Results are posted in the registry (first posted 3 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Tear Lipid Layer Thickness (time frame: 15 minutes). 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 3 Feb 2021; AzTrials last refreshed its copy on 2 Nov 2026.