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| Name | Class |
|---|---|
| Advanced Vision Research | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TheraTears® Lubricant Eye Drop | Drug |
| ||
| TheraTears® preservative-free single-use containers |
| Measure | Description | Time Frame |
|---|---|---|
| Change over time of OSDI score | Ocular Surface Disease Index (OSDI) questionnaire score | At screening, 2 weeks, 1 month and 3 months |
| Change over time of Visual analogue scores | At screening, 2 weeks, 1 month and 3 months | |
| Change over time of Tear osmolarity | At screening, 1 month and 3 months | |
| Change over time of Tear film breakup time | At screening, 1 month and 3 months | |
| Change over time of Corneal staining | At screening, 1 month and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change over time of Lid wiper epitheliopathy | At screening, 1 month and 3 months | |
| Change over time of Meibomian gland expressibility | At screening, 1 month and 3 months | |
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Inclusion Criteria:
Exclusion Criteria:
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;
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Contact Lens Research, University of Waterloo School of Optometry & Vision Science | Waterloo | Ontario | N2L3G1 | Canada |
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| Drug |
|
| TheraTears® Nutrition | Dietary Supplement |
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| TheraTears® TheraLid® Eyelid Cleanser | Other |
|
| Change over time of Meibum quality |
| At screening, 1 month and 3 months |
| Change over time of Tear film lipid layer thickness | At screening, 1 month and 3 months |
| Change over time of Tear meniscus height | At screening, 1 month and 3 months |
| Change over time of Schirmer's I scores | At screening, 1 month and 3 months |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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