A Study to Determine the Relief of Dry Eye Symptoms With the Use of TheraTears® Products (DUNLIN) (DUNLIN)
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ClinicalTrials.gov Identifier: NCT02014922 |
Recruitment Status :
Completed
First Posted : December 18, 2013
Last Update Posted : March 11, 2015
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Condition or disease | Intervention/treatment | Phase |
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Dry Eye Syndromes | Drug: TheraTears® Lubricant Eye Drop Drug: TheraTears® preservative-free single-use containers Dietary Supplement: TheraTears® Nutrition Other: TheraTears® TheraLid® Eyelid Cleanser | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 33 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Study to Determine the Relief of Dry Eye Symptoms With the Use of TheraTears® Products |
Study Start Date : | December 2013 |
Actual Primary Completion Date : | November 2014 |
Actual Study Completion Date : | November 2014 |

Arm | Intervention/treatment |
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No Intervention: Control
Participants randomized to the control group will be allowed to continue using their habitual artificial tears, and / or additional habitual concurrent dry eye treatments.
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Experimental: Treatment
Participants in the study treatment group will receive all four products:
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Drug: TheraTears® Lubricant Eye Drop Drug: TheraTears® preservative-free single-use containers Dietary Supplement: TheraTears® Nutrition Other: TheraTears® TheraLid® Eyelid Cleanser |
- 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 ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014922
Canada, Ontario | |
Centre for Contact Lens Research, University of Waterloo School of Optometry & Vision Science | |
Waterloo, Ontario, Canada, N2L3G1 |
Responsible Party: | University of Waterloo |
ClinicalTrials.gov Identifier: | NCT02014922 |
Other Study ID Numbers: |
P/439/13/AVR |
First Posted: | December 18, 2013 Key Record Dates |
Last Update Posted: | March 11, 2015 |
Last Verified: | March 2015 |
Keratoconjunctivitis Sicca Dry Eye Syndromes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Eye Diseases Keratitis Corneal Diseases Lacrimal Apparatus Diseases Vitamin E alpha-Tocopherol Tocopherols Carboxymethylcellulose Sodium |
Ophthalmic Solutions Lubricant Eye Drops Pharmaceutical Solutions Laxatives Gastrointestinal Agents Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Vitamins Micronutrients Nutrients Growth Substances |