Dry Eye DiseaseNCT01321424
Diurnal Variation in Tear Osmolarity
An observational study of Dry Eye Disease, run by Ophthalmic Consultants of Long Island at 6 sites in United States.
Trial summary
The purpose of this study is to measure the change in Tear Osmolarity during the course of the day to support clinical diagnosis of aqueous deficiency or meibomian gland disease and differentiate between the two forms of dry eye. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Disease
- How many people
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2011to Mar 2016
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care facility
Who may be able to join
- Healthy males and females ≥ 18 years old
- Negative urine pregnancy results for females of childbearing potential
- Able to read and sign an informed consent form and show willingness to comply with the study protocol visits and procedures
- Has 20/40 BCVA or better in at least one eye
- Does not currently wear contact lenses
- For Aqueous-Deficiency Group:
Show all 24Show fewer
- Has symptoms of Dry Eye
- Schirmer testing ≤ 10 mm
- Tear Break Up Time ≤ 8 seconds
- Conjunctival staining ≥ 1+
- Meibomian gland inspissations ≤ 1+
- No lid thickening, lid erythema, or thickened, turbid meibomian gland secretions
- For Meibomian Gland Disease Group:
- Has symptoms of Dry Eye
- Schirmer testing ≥ 10 mm
- Tear Break Up Time ≤ 8 seconds
- Conjunctival staining ≥ 1+
- Meibomian gland inspissations ≥ 2+
- For Normal Group:
- Has no symptoms of Dry Eye
- Schirmer testing > 10 mm
- Tear Break Up Time > 8 seconds
- No or trace Conjunctival staining
- No Meibomian gland inspissations
Who cannot join
- Any topical medication within the last three months, except for artificial tears
- Unable to discontinue use of artificial tears during the course of the day for Visit 2
- Any Systemic disease, which in the opinion of the Investigator, may affect ocular health or confound study results
- Any active ocular disease other than Dry Eye Disease, Meibomian Gland Disease or Sjogren's Syndrome, which in the opinion of the Investigator, may affect ocular health or confound study results
- Clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities
- Clinically significant limbal or bulbar injection, or corneal staining not due to DES
Show all 11Show fewer
- Has worn hard or rigid gas permeable contact lenses within 1 year
- Has worn soft contact lenses within 1 week
- Has had eye surgery or an eye injury within 6 months
- Positive urine pregnancy results for females of childbearing potential
- Any changes in current medication within 30 days of Visit 2 or anticipated change during course of study, which in the opinion of the Investigator may confound study results
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Ophthalmic Consultants of Connecticut
Fairfield, Connecticut, 06824
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563
Ophthalmic Consultants of Long Island
Manhasset, New York, 11030
Ophthalmic Consultants of Long Island
Port Jefferson, New York, 11777
Ophthalmic Consultants of Long Island
Rockville Centre, New York, 11570
Ophthalmic Consultants of Long Island
Valley Stream, New York, 11581
About this study
Official title: Investigator Sponsored, Pilot Study to Assess the Diurnal Variation in Tear Osmolarity as a Predictor of Dry Eye Disease Etiology
The purpose of this study is to measure the change in Tear Osmolarity during the course of the day to support clinical diagnosis of aqueous deficiency or meibomian gland disease and differentiate between the two forms of dry eye.
Read the detailed description
The premise of this study is that dry eye disease, specifically tear osmolarity, changes during the course of the day based on the etiology of the dry eye and that aqueous-deficiency dry eye will worsen during the course of the day while meibomian gland deficiency will stabilize or possibly even improve during the course of the day.
- Conditions
- Dry Eye Disease
- Keywords
- Dry Eye, Tear Osmolarity, Meibomain Gland Disease, Aqueous Dificiency, Tear film abnormality
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Aqueous Dificiency Dry Eye | 20 Participants | |
| Meibomian Gland Disease Dry Eye | 20 Participants | |
| Normal Eye | 20 Participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measured difference in Tear Osmolarity during the course of the day to support clinical diagnosis and differentiate between aqueous-deficiency and meibomian gland disease.
Measured: 1 Day (AM and PM Diurnal)
Secondary outcomes (1)
Ocular Improvement
Improvement in Ocular Surface Disease Index, Best Corrected Visual Acuity, Uncorrected Visual Acuity, Slit Lamp Exam, Schirmer test, Lissamine green conjunctival staining, Fluorescein corneal staining and Tear Break Up Time
Measured: 31 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionFeb 2016
- Study completionMar 2016
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ophthalmic Consultants of Long Island
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Eric D Donnenfeld, MD, Principal investigator, Ophthalmic Consultants of Long IslandBarbara Burger, RN, Study director, Ophthalmic Consultants of Long Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321424
- Sponsor's protocol ID
- ALRGN01
- Status last verified
- Apr 2016
- First submitted
- 21 Mar 2011
- Last updated
- 25 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: PI will present study outcomes to associates
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator Sponsored, Pilot Study to Assess the Diurnal Variation in Tear Osmolarity as a Predictor of Dry Eye Disease Etiology
- ClinicalTrials.gov ID
- NCT01321424
- Acronym / sponsor ID
- ALRGN01
- Conditions
- Dry Eye Disease
- Keywords
- Dry Eye, Tear Osmolarity, Meibomain Gland Disease, Aqueous Dificiency, Tear film abnormality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ophthalmic Consultants of Long IslandUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Mar 2011
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 23 Mar 2011 (estimated)
- 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.
The purpose of this study is to measure the change in Tear Osmolarity during the course of the day to support clinical diagnosis of aqueous deficiency or meibomian gland disease and differentiate between the two forms of dry eye.
Detailed description
The premise of this study is that dry eye disease, specifically tear osmolarity, changes during the course of the day based on the etiology of the dry eye and that aqueous-deficiency dry eye will worsen during the course of the day while meibomian gland deficiency will stabilize or possibly even improve during the course of the day.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aqueous Dificiency Dry Eye | – | –20 Participants |
| Meibomian Gland Disease Dry Eye | – | –20 Participants |
| Normal Eye | – | –20 Participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care facility
Key inclusion criteria (24 listed)
- Healthy males and females ≥ 18 years old
- Negative urine pregnancy results for females of childbearing potential
- Able to read and sign an informed consent form and show willingness to comply with the study protocol visits and procedures
- Has 20/40 BCVA or better in at least one eye
- Does not currently wear contact lenses
Key exclusion criteria (11 listed)
- Any topical medication within the last three months, except for artificial tears
- Unable to discontinue use of artificial tears during the course of the day for Visit 2
- Any Systemic disease, which in the opinion of the Investigator, may affect ocular health or confound study results
- Any active ocular disease other than Dry Eye Disease, Meibomian Gland Disease or Sjogren's Syndrome, which in the opinion of the Investigator, may affect ocular health or confound study results
- Clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The measured difference in Tear Osmolarity during the course of the day to support clinical diagnosis and differentiate between aqueous-deficiency and meibomian gland disease.
Time frame: 1 Day (AM and PM Diurnal)
1 secondary outcome
Ocular Improvement
Time frame: 31 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 25 Apr 2016.
- Individual participant dataSharing planned: Yes. PI will present study outcomes to associates
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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.
Eric D Donnenfeld, MD principal investigator
Ophthalmic Consultants of Long Island
Barbara Burger, RN study director
Ophthalmic Consultants of Long Island
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Disease, run by Ophthalmic Consultants of Long Island at 6 sites 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 24 inclusion and 11 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 25 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The measured difference in Tear Osmolarity during the course of the day to support clinical diagnosis and differentiate between aqueous-deficiency and meibomian gland disease. (time frame: 1 Day (AM and PM Diurnal)). 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 25 Apr 2016.