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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
Sponsor:
Collaborator:
Advanced Vision Research
Information provided by (Responsible Party):
University of Waterloo

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
Experimental: Treatment

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
 Drug: TheraTears® Lubricant Eye Drop
Drug: TheraTears® preservative-free single-use containers
Dietary Supplement: TheraTears® Nutrition
Other: TheraTears® TheraLid® Eyelid Cleanser


Outcome Measures
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Primary Outcome Measures :
  1. Change over time of OSDI score [ Time Frame: At screening, 2 weeks, 1 month and 3 months ]
    Ocular Surface Disease Index (OSDI) questionnaire score

  2. Change over time of Visual analogue scores [ Time Frame: At screening, 2 weeks, 1 month and 3 months ]
  3. Change over time of Tear osmolarity [ Time Frame: At screening, 1 month and 3 months ]
  4. Change over time of Tear film breakup time [ Time Frame: At screening, 1 month and 3 months ]
  5. Change over time of Corneal staining [ Time Frame: At screening, 1 month and 3 months ]

Secondary Outcome Measures :
  1. Change over time of Lid wiper epitheliopathy [ Time Frame: At screening, 1 month and 3 months ]
  2. Change over time of Meibomian gland expressibility [ Time Frame: At screening, 1 month and 3 months ]
  3. Change over time of Meibum quality [ Time Frame: At screening, 1 month and 3 months ]
  4. Change over time of Tear film lipid layer thickness [ Time Frame: At screening, 1 month and 3 months ]
  5. Change over time of Tear meniscus height [ Time Frame: At screening, 1 month and 3 months ]
  6. Change over time of Schirmer's I scores [ Time Frame: At screening, 1 month and 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Centre for Contact Lens Research, University of Waterloo School of Optometry & Vision Science
Waterloo, Ontario, Canada, N2L3G1
Sponsors and Collaborators
University of Waterloo
Advanced Vision Research
More Information
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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
Additional relevant MeSH terms:
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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