A Study to Determine the Relief of Dry Eye Symptoms With the Use of TheraTears® Products (DUNLIN)
- Conditions
- Dry Eye Syndromes
- Interventions
- Dietary Supplement: TheraTears® NutritionOther: TheraTears® TheraLid® Eyelid Cleanser
- Registration Number
- NCT02014922
- Lead Sponsor
- University of Waterloo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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.
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Is participating in any concurrent clinical or research study;
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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.
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Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
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Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
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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;
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Is aphakic;
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Has undergone refractive error surgery;
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Has taken part in another (pharmaceutical) research study within the last 30 days;
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Has worn contact lenses within the past 5 years;
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Is currently using or have used omega 3 supplements in the past 3 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment TheraTears® preservative-free single-use containers 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 Treatment TheraTears® Lubricant Eye Drop 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 Treatment TheraTears® TheraLid® Eyelid Cleanser 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 Treatment TheraTears® Nutrition 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
- Primary Outcome Measures
Name Time Method Change over time of OSDI score At screening, 2 weeks, 1 month and 3 months Ocular Surface Disease Index (OSDI) questionnaire score
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
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (1)
Centre for Contact Lens Research, University of Waterloo School of Optometry & Vision Science
🇨🇦Waterloo, Ontario, Canada