Dry EyeNCT02005874
A Study To Investigate The Effects Of A Low Humidity Environment And Visual Tasking On Tear Film Protein Composition
An observational study of Dry Eye, run by Inflamax Research Incorporated at 1 site in Canada.
Trial summary
The purpose of the study is to collect valuable data on the role of controlled humidity, temperature, airflow, and visual tasking in altering the tear film protein composition. The results from this preliminary study will help to explore the role of tear film markers in inflammatory and disease conditions. 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
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Nov 2013
- 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: Approximately 16 healthy adult volunteers (male or female), aged 18 and older, of which 50% must have signs and symptoms of mild-moderate dry eye syndrome.
Who may be able to join
- Male or female, aged 18 or older in good general health on the basis of medical history and ophthalmic examination
- Subjects must have no known systemic disease or need for medication which may interfere with the study
- Subjects must have healthy eyes (no ophthalmic medication use nor current ocular infection) and concomitant medication may be permitted at the discretion of the investigator as long as there is no interference with study objectives or subject's safety.
- Subjects must have visual acuity best corrected to 20/50 or better for each eye with optometrist discretion for subjects with amblyopia.
- Subjects must be willing to discontinue their own contact lens wear for the period 7 days before Screening Visit 1 through to the end of the study.
- Ability to comply with study protocol, provide written consent and complete study
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- INCLUSION CRITERIA FOR THE MILD - MODERATE DRY EYE SUBJECTS WILL INCLUDE:
- OSDI questionnaire score of ≥15
- Ocular dryness score of >1 (0-4)
- TBUT <7 sec
- Biomicroscopic assessment of superficial punctate keratitis (SPK) of at least 1 in a scale of (0-4) indicative of dry eye syndrome over the 5 zone NEI cornea
- INCLUSION CRITERIA FOR THE NON-DRY EYE SUBJECTS WILL INCLUDE:
- OSDI questionnaire score <15
- TBUT ≥7 sec
- Biomicroscopic assessment reveals no SPK and good tear meniscus
- Ocular dryness score of 0 (0-4)
Who cannot join
- Any ocular disease including keratoconus and Sjogren's syndrome
- Any tarsal abnormalities or corneal neovascularization >Grade2
- Ocular surgery including refractive surgery within the last 12 months
- Intraocular Pressure (IOP)>23mmHg and utilization of any prescribed ophthalmic medication
- Clinically significant disease or abnormality which the investigator may judge unsafe to participate in the study and/or interfere with the outcome of the study, including clinically significant physical findings on slitlamp examination or fundus evaluation.
- Pregnancy or breastfeeding, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period, or for 30 days following the study period.
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- Subjects who require the use of antihistamines, corticosteroids or anti-glaucoma medications on a regular basis and who are unwilling to discontinue the use of these medications for appropriate periods prior to the study visits. (Section 4.3 Table 1: Prohibited Medication)
- Current participation in another clinical study involving an experimental treatment, or participation in such a study within 30 days prior to study entry.
- A known or suspected hypersensitivity, and/or contraindication to any of the ingredients of the investigational products.
- Not meeting concomitant medication washouts
- Inability to discontinue any ophthalmic eyedrops including OTC therapies.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to collect valuable data on the role of controlled humidity, temperature, airflow, and visual tasking in altering the tear film protein composition. The results from this preliminary study will help to explore the role of tear film markers in inflammatory and disease conditions. This can also be extended to understand the role of the tear film in protecting the ocular surface when individuals are exposed to low humidity environments which may incite discomfort symptoms.
Read the detailed description
An investigational study, to evaluate the effects of a low humidity environment and visual tasking on tear film protein composition Screening Visit 1A: Subjects will be screened based on their medical history, symptom questionnaires (e.g. OSDI) and a full ophthalmic examination.
Screening Visit 1A: Subjects will be screened based on their medical history, symptom questionnaires (e.g. OSDI) and a full ophthalmic examination which will include baseline measures including visual acuity and biomicroscopic evaluations of the anterior segment (i.e. Tear Break Up Time (TBUT), corneal and conjunctival staining, lid wiper epitheliopathy, conjunctival redness and tear film evaluation).
Post-screening, approximately sixteen (16) subjects, meeting the inclusion and exclusion criteria, will be asked to participate in the study. Of those enrolled in the study, approximately eight (8) subjects will have mild to moderate symptoms and signs of dry eye syndrome and approximately eight (8) subject will not have signs or symptoms of dry eye syndrome.
On Visit IB, subjects will have VA and biomicroscopy performed. A basal tear sample of approximately 5 µL will be collected via capillary tubes from the outer canthus of each eye and stored on dry ice then placed in a -80c ± 10°C freezer for storage. Photographic assessments of the ocular surface may be taken. After waiting 5 minutes for the tear film to stabilize, tear osmolarity may be measured in each eye.
Prior to entered the low humidity Environmental Exposure Chamber (EEC), subjects will be asked to fill out their baseline symptoms. Subjects will then enter and remain in the EEC for approximately 180 minutes and symptom diary cards will be completed after entry at pre-specified timepoints. Throughout the EEC visit, subjects will be asked to complete visual tasks on a digital screen to ensure the ocular surface is exposed to the airflow and humidity levels in the room.
After approximately 180 minutes of exposure to dry eye conditions, prior to exiting chamber, basal tears will be collected via capillary tubes for each eye and stored on dry ice then placed in a -80°C ± 10°C freezer for storage. Photographic assessments of the ocular surface may be taken. After waiting 5 minutes for the tear film to stabilize, tear osmolarity may be measured for each eye.
After exiting the EEC, subjects will remain in the medical clinic for an additional 60 minutes and will continue to conduct visual tasks during this period. Symptom diary cards will then be completed at pre-specified time points after leaving the EEC.
Following 60 minutes in the clinic and prior to study exit, a final collection of basal tears via capillary tubes will be taken and stored on dry ice and then placed in a -80°C ± 10°C freezer for storage. Once again photographic assessments may be taken. Biomicroscopy will be performed.
The tear samples collected before and after exposure to the chamber will be taken from (-80°C) freezer storage and packaged on dry ice for shipment to the University of Waterloo Centre for Contact Lens Research (CCLR) for analysis. A variety of proteins and cytokines will be analyzed.
- Conditions
- Dry Eye
- 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 |
|---|---|---|
| Dry eye | Not described | |
| Non-dry eye | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tear Protein and/or Cytokine Composition
Measured: Measured at time 0, then 10, 20, 30, 60, 90, 120, 150, 180 min after entering the EEC and time 10, 20, 30, 60 min after exiting the EEC
Secondary outcomes (5)
Clinical and Subjective Sign and Symptom Scores
MCFB in total ocular symptom score (TOSS)
Measured: Measured at time 0, then 10, 20, 30, 60, 90, 120, 150, 180 min after entering the EEC and time 10, 20, 30, 60 min after exiting the EEC
Clinical and Subjective Sign and Symptom Scores
MCFB in total corneal staining using fluorescein
Measured: Measured at time 0, and 60 min after exiting the EEC
Clinical and Subjective Sign and Symptom Scores
MCFB in total conjunctival staining using lissamine green
Measured: Measured at time 0, and 60 min after exiting the EEC
Clinical and Subjective Sign and Symptom Scores
MCFB in individual symptom scores
Measured: Measured at time 0, then 10, 20, 30, 60, 90, 120, 150, 180 min after entering the EEC and time 10, 20, 30, 60 min after exiting the EEC
Clinical and Subjective Sign and Symptom Scores
MCFB in Tear film Break Up Time (TBUT)
Measured: Measured at time 0, and 60 min after exiting the EEC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2013
- Study completionNov 2013
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inflamax Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005874
- Sponsor's protocol ID
- 13-RD-01
- Other IDs
- EGP #445977-12
- Status last verified
- Dec 2013
- First submitted
- 28 Nov 2013
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study To Investigate The Effects Of A Low Humidity Environment And Visual Tasking On Tear Film Protein Composition
- ClinicalTrials.gov ID
- NCT02005874
- Acronym / sponsor ID
- 13-RD-01
- Conditions
- Dry Eye
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Inflamax Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 9 Dec 2013 (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 the study is to collect valuable data on the role of controlled humidity, temperature, airflow, and visual tasking in altering the tear film protein composition. The results from this preliminary study will help to explore the role of tear film markers in inflammatory and disease conditions. This can also be extended to understand the role of the tear film in protecting the ocular surface when individuals are exposed to low humidity environments which may incite discomfort symptoms.
Detailed description
An investigational study, to evaluate the effects of a low humidity environment and visual tasking on tear film protein composition Screening Visit 1A: Subjects will be screened based on their medical history, symptom questionnaires (e.g. OSDI) and a full ophthalmic examination.
Screening Visit 1A: Subjects will be screened based on their medical history, symptom questionnaires (e.g. OSDI) and a full ophthalmic examination which will include baseline measures including visual acuity and biomicroscopic evaluations of the anterior segment (i.e. Tear Break Up Time (TBUT), corneal and conjunctival staining, lid wiper epitheliopathy, conjunctival redness and tear film evaluation).
Post-screening, approximately sixteen (16) subjects, meeting the inclusion and exclusion criteria, will be asked to participate in the study. Of those enrolled in the study, approximately eight (8) subjects will have mild to moderate symptoms and signs of dry eye syndrome and approximately eight (8) subject will not have signs or symptoms of dry eye syndrome.
On Visit IB, subjects will have VA and biomicroscopy performed. A basal tear sample of approximately 5 µL will be collected via capillary tubes from the outer canthus of each eye and stored on dry ice then placed in a -80c ± 10°C freezer for storage. Photographic assessments of the ocular surface may be taken. After waiting 5 minutes for the tear film to stabilize, tear osmolarity may be measured in each eye.
Prior to entered the low humidity Environmental Exposure Chamber (EEC), subjects will be asked to fill out their baseline symptoms. Subjects will then enter and remain in the EEC for approximately 180 minutes and symptom diary cards will be completed after entry at pre-specified timepoints. Throughout the EEC visit, subjects will be asked to complete visual tasks on a digital screen to ensure the ocular surface is exposed to the airflow and humidity levels in the room.
After approximately 180 minutes of exposure to dry eye conditions, prior to exiting chamber, basal tears will be collected via capillary tubes for each eye and stored on dry ice then placed in a -80°C ± 10°C freezer for storage. Photographic assessments of the ocular surface may be taken. After waiting 5 minutes for the tear film to stabilize, tear osmolarity may be measured for each eye.
After exiting the EEC, subjects will remain in the medical clinic for an additional 60 minutes and will continue to conduct visual tasks during this period. Symptom diary cards will then be completed at pre-specified time points after leaving the EEC.
Following 60 minutes in the clinic and prior to study exit, a final collection of basal tears via capillary tubes will be taken and stored on dry ice and then placed in a -80°C ± 10°C freezer for storage. Once again photographic assessments may be taken. Biomicroscopy will be performed.
The tear samples collected before and after exposure to the chamber will be taken from (-80°C) freezer storage and packaged on dry ice for shipment to the University of Waterloo Centre for Contact Lens Research (CCLR) for analysis. A variety of proteins and cytokines will be analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry eye | – | – |
| Non-dry eye | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 16 healthy adult volunteers (male or female), aged 18 and older, of which 50% must have signs and symptoms of mild-moderate dry eye syndrome.
Key inclusion criteria (16 listed)
- Male or female, aged 18 or older in good general health on the basis of medical history and ophthalmic examination
- Subjects must have no known systemic disease or need for medication which may interfere with the study
- Subjects must have healthy eyes (no ophthalmic medication use nor current ocular infection) and concomitant medication may be permitted at the discretion of the investigator as long as there is no interference with study objectives or subject's safety.
- Subjects must have visual acuity best corrected to 20/50 or better for each eye with optometrist discretion for subjects with amblyopia.
- Subjects must be willing to discontinue their own contact lens wear for the period 7 days before Screening Visit 1 through to the end of the study.
Key exclusion criteria (11 listed)
- Any ocular disease including keratoconus and Sjogren's syndrome
- Any tarsal abnormalities or corneal neovascularization >Grade2
- Ocular surgery including refractive surgery within the last 12 months
- Intraocular Pressure (IOP)>23mmHg and utilization of any prescribed ophthalmic medication
- Clinically significant disease or abnormality which the investigator may judge unsafe to participate in the study and/or interfere with the outcome of the study, including clinically significant physical findings on slitlamp examination or fundus evaluation.
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
Change in Tear Protein and/or Cytokine Composition
Time frame: Measured at time 0, then 10, 20, 30, 60, 90, 120, 150, 180 min after entering the EEC and time 10, 20, 30, 60 min after exiting the EEC
5 secondary outcomes
Clinical and Subjective Sign and Symptom Scores
Time frame: Measured at time 0, then 10, 20, 30, 60, 90, 120, 150, 180 min after entering the EEC and time 10, 20, 30, 60 min after exiting the EEC
Clinical and Subjective Sign and Symptom Scores
Time frame: Measured at time 0, and 60 min after exiting the EEC
Clinical and Subjective Sign and Symptom Scores
Time frame: Measured at time 0, and 60 min after exiting the EEC
Clinical and Subjective Sign and Symptom Scores
Time frame: Measured at time 0, then 10, 20, 30, 60, 90, 120, 150, 180 min after entering the EEC and time 10, 20, 30, 60 min after exiting the EEC
Clinical and Subjective Sign and Symptom Scores
Time frame: Measured at time 0, and 60 min after exiting the EEC
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 9 Dec 2013.
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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?
An observational study of Dry Eye, run by Inflamax Research Incorporated 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 16 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 9 Dec 2013. 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.
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 in Tear Protein and/or Cytokine Composition (time frame: Measured at time 0, then 10, 20, 30, 60, 90, 120, 150, 180 min after entering the EEC and time 10, 20, 30, 60 min after exiting the EEC). 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 9 Dec 2013.