Clinical trial NCT02014922: A Study to Determine the Relief of Dry Eye Symptoms With the Use of TheraTears® Products (DUNLIN)
Official title: A Study to Determine the Relief of Dry Eye Symptoms With the Use of TheraTears® Products
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: Advanced Vision Research
First posted: 2013-12-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Is between 18 and 65 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Exhibits symptoms of dry eye for at least 3 months;
5. Has an OSDI score of ≥ 23;
6. 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;
7. Has an average non-invasive tear breakup time ≤ 5.00 seconds in at least one eye.

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. 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.
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
6. Is pregnant, lactating or planning a pregnancy at the time of enrollment, as determined verbally;
7. Is aphakic;
8. Has undergone refractive error surgery;
9. Has taken part in another (pharmaceutical) research study within the last 30 days;
10. Has worn contact lenses within the past 5 years;
11. Is currently using or have used omega 3 supplements in the past 3 months.

Primary outcomes:
measure: Change over time of OSDI score
timeFrame: At screening, 2 weeks, 1 month and 3 months
measure: Change over time of Visual analogue scores
timeFrame: At screening, 2 weeks, 1 month and 3 months
measure: Change over time of Tear osmolarity
timeFrame: At screening, 1 month and 3 months
measure: Change over time of Tear film breakup time
timeFrame: At screening, 1 month and 3 months
measure: Change over time of Corneal staining
timeFrame: At screening, 1 month and 3 months
Secondary outcomes:
measure: Change over time of Lid wiper epitheliopathy
timeFrame: At screening, 1 month and 3 months
measure: Change over time of Meibomian gland expressibility
timeFrame: At screening, 1 month and 3 months
measure: Change over time of Meibum quality
timeFrame: At screening, 1 month and 3 months
measure: Change over time of Tear film lipid layer thickness
timeFrame: At screening, 1 month and 3 months
measure: Change over time of Tear meniscus height
timeFrame: At screening, 1 month and 3 months
measure: Change over time of Schirmer's I scores
timeFrame: At screening, 1 month and 3 months
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research, University of Waterloo School of Optometry & Vision Science
state: Ontario
Study officials:
References: