Dry Eye SyndromesPhase 4DUNLINNCT02014922
A Study to Determine the Relief of Dry Eye Symptoms With the Use of TheraTears® Products (DUNLIN)
A Phase 4 study testing TheraTears® Lubricant Eye Drop, TheraTears® preservative-free single-use containers and TheraTears® Nutrition in people with Dry Eye Syndromes, run by University of Waterloo at 1 site in Canada.
Trial summary
Dry eye is a very common condition that most often affects women and the elderly, and can be caused when the eyes do not produce enough tears, or when the tears evaporate too quickly. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- TheraTears® Lubricant Eye Drop, TheraTears® preservative-free single-use containers and TheraTears® Nutrition
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Nov 2014
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Is between 18 and 65 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Exhibits symptoms of dry eye for at least 3 months;
- Has an OSDI score of ≥ 23;
- Is currently on a non-omega 3 dry eye treatment regimen that, at the minimum consists of instilling artificial tears at least once a day for the past 3 months;
- Has an average non-invasive tear breakup time ≤ 5.00 seconds in at least one eye.
Who cannot join
- Is participating in any concurrent clinical or research study;
- Has any known active* ocular disease and/or infection and/or allergies;
- For the purposes of study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are typical findings and are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
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- Is pregnant, lactating or planning a pregnancy at the time of enrollment, as determined verbally;
- Is aphakic;
- Has undergone refractive error surgery;
- Has taken part in another (pharmaceutical) research study within the last 30 days;
- Has worn contact lenses within the past 5 years;
- Is currently using or have used omega 3 supplements in the past 3 months.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Contact Lens Research, University of Waterloo School of Optometry & Vision Science
Waterloo, Ontario, N2L3G1
About this study
Official title: A Study to Determine the Relief of Dry Eye Symptoms With the Use of TheraTears® Products
Dry eye is a very common condition that most often affects women and the elderly, and can be caused when the eyes do not produce enough tears, or when the tears evaporate too quickly. Although there isn't a simple cure for dry eye, there are numerous products on the market that attempt to help relieve some of the discomfort caused by this condition. Some of these products include artificial tears, omega-3 supplements, and/or anti-inflammatory medications. The purpose of this study is to evaluate the performance of a combination of TheraTears® products, and to compare them with the product(s) you have been using.
- Conditions
- Dry Eye Syndromes
- Being tested
- TheraTears® Lubricant Eye Drop, TheraTears® preservative-free single-use containers, TheraTears® Nutrition, TheraTears® TheraLid® Eyelid Cleanser
- 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.
TheraTears® Lubricant Eye DropDrug
TheraTears® preservative-free single-use containersDrug
TheraTears® NutritionDietary supplement
TheraTears® TheraLid® Eyelid CleanserOther
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants randomized to the control group will be allowed to continue using their habitual artificial tears, and / or additional habitual concurrent dry eye treatments. |
| Treatment | Experimental | Participants in the study treatment group will receive all four products:
* TheraTears® Lubricant Eye Drop (15mL) - Dosage: Ophthalmic, 1 or 2 drops, prn
* TheraTears® preservative-free single-use containers (32-pack, 0.6mL each) - Dosage: Ophthalmic, 1 or 2 drops, prn
* TheraTears® Nutrition (90 pack) - Dosage: Oral, 3 capsules QD
* TheraTears® TheraLid® Eyelid Cleanser (48mL) - Dosage: Ophthalmic, 1 or 2 application OU, QD Receives: Drug: TheraTears® Lubricant Eye Drop; Drug: TheraTears® preservative-free single-use containers; Dietary Supplement: TheraTears® Nutrition; Other: TheraTears® TheraLid® Eyelid Cleanser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change over time of OSDI score
Ocular Surface Disease Index (OSDI) questionnaire score
Measured: At screening, 2 weeks, 1 month and 3 months
Change over time of Visual analogue scores
Measured: At screening, 2 weeks, 1 month and 3 months
Change over time of Tear osmolarity
Measured: At screening, 1 month and 3 months
Change over time of Tear film breakup time
Measured: At screening, 1 month and 3 months
Change over time of Corneal staining
Measured: At screening, 1 month and 3 months
Secondary outcomes (6)
Change over time of Lid wiper epitheliopathy
Measured: At screening, 1 month and 3 months
Change over time of Meibomian gland expressibility
Measured: At screening, 1 month and 3 months
Change over time of Meibum quality
Measured: At screening, 1 month and 3 months
Change over time of Tear film lipid layer thickness
Measured: At screening, 1 month and 3 months
Change over time of Tear meniscus height
Measured: At screening, 1 month and 3 months
Change over time of Schirmer's I scores
Measured: At screening, 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionNov 2014
- Study completionNov 2014
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.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Vision Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014922
- Sponsor's protocol ID
- P/439/13/AVR
- Acronym
- DUNLIN
- Status last verified
- Mar 2015
- First submitted
- 12 Dec 2013
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Relief of Dry Eye Symptoms With the Use of TheraTears® Products
- ClinicalTrials.gov ID
- NCT02014922
- Acronym / sponsor ID
- DUNLIN / P/439/13/AVR
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Advanced Vision Research
- Study start
- Dec 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 18 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.
Dry eye is a very common condition that most often affects women and the elderly, and can be caused when the eyes do not produce enough tears, or when the tears evaporate too quickly. Although there isn't a simple cure for dry eye, there are numerous products on the market that attempt to help relieve some of the discomfort caused by this condition. Some of these products include artificial tears, omega-3 supplements, and/or anti-inflammatory medications. The purpose of this study is to evaluate the performance of a combination of TheraTears® products, and to compare them with the product(s) you have been using.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants randomized to the control group will be allowed to continue using their habitual artificial tears, and / or additional habitual concurrent dry eye treatments. |
| Treatment | Experimental | Drug: TheraTears® Lubricant Eye Drop, Drug: TheraTears® preservative-free single-use containers, Dietary Supplement: TheraTears® Nutrition, Other: TheraTears® TheraLid® Eyelid CleanserParticipants in the study treatment group will receive all four products: * TheraTears® Lubricant Eye Drop (15mL) - Dosage: Ophthalmic, 1 or 2 drops, prn * TheraTears® preservative-free single-use containers (32-pack, 0.6mL each) - Dosage: Ophthalmic, 1 or 2 drops, prn * TheraTears® Nutrition (90 pack) - Dosage: Oral, 3 capsules QD * TheraTears® TheraLid® Eyelid Cleanser (48mL) - Dosage: Ophthalmic, 1 or 2 application OU, QD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Is between 18 and 65 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Exhibits symptoms of dry eye for at least 3 months;
- Has an OSDI score of ≥ 23;
Key exclusion criteria (12 listed)
- Is participating in any concurrent clinical or research study;
- Has any known active* ocular disease and/or infection and/or allergies;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
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 |
|---|---|---|
| TheraTears® Lubricant Eye Drop | Drug | Treatment |
| TheraTears® preservative-free single-use containers | Drug | Treatment |
| TheraTears® Nutrition | Dietary supplement | Treatment |
| TheraTears® TheraLid® Eyelid Cleanser | Other | Treatment |
Primary outcome
Change over time of OSDI score
Time frame: At screening, 2 weeks, 1 month and 3 months
Ocular Surface Disease Index (OSDI) questionnaire score
Change over time of Visual analogue scores
Time frame: At screening, 2 weeks, 1 month and 3 months
Change over time of Tear osmolarity
Time frame: At screening, 1 month and 3 months
Change over time of Tear film breakup time
Time frame: At screening, 1 month and 3 months
Change over time of Corneal staining
Time frame: At screening, 1 month and 3 months
6 secondary outcomes
Change over time of Lid wiper epitheliopathy
Time frame: At screening, 1 month and 3 months
Change over time of Meibomian gland expressibility
Time frame: At screening, 1 month and 3 months
Change over time of Meibum quality
Time frame: At screening, 1 month and 3 months
Change over time of Tear film lipid layer thickness
Time frame: At screening, 1 month and 3 months
Change over time of Tear meniscus height
Time frame: At screening, 1 month and 3 months
Change over time of Schirmer's I scores
Time frame: At screening, 1 month and 3 months
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 11 Mar 2015.
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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 Phase 4 study testing TheraTears® Lubricant Eye Drop, TheraTears® preservative-free single-use containers and TheraTears® Nutrition in people with Dry Eye Syndromes, run by University of Waterloo 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 7 inclusion and 12 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 11 Mar 2015. 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.
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?
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 over time of OSDI score (time frame: At screening, 2 weeks, 1 month and 3 months). The study lists 5 primary outcomes in all. 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 11 Mar 2015.