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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

Tracking Information
First Submitted Date  ICMJE December 12, 2013
First Posted Date  ICMJE December 18, 2013
Last Update Posted Date March 11, 2015
Study Start Date  ICMJE December 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2013)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Determine the Relief of Dry Eye Symptoms With the Use of TheraTears® Products (DUNLIN)
Official Title  ICMJE A Study to Determine the Relief of Dry Eye Symptoms With the Use of TheraTears® Products
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye Syndromes
Intervention  ICMJE
  • Drug: TheraTears® Lubricant Eye Drop
  • Drug: TheraTears® preservative-free single-use containers
  • Dietary Supplement: TheraTears® Nutrition
  • Other: TheraTears® TheraLid® Eyelid Cleanser
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: TheraTears® Lubricant Eye Drop
    • Drug: TheraTears® preservative-free single-use containers
    • Dietary Supplement: TheraTears® Nutrition
    • Other: TheraTears® TheraLid® Eyelid Cleanser
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2015)
33
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2013)
40
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02014922
Other Study ID Numbers  ICMJE P/439/13/AVR
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Waterloo
Study Sponsor  ICMJE University of Waterloo
Collaborators  ICMJE Advanced Vision Research
Investigators  ICMJE Not Provided
PRS Account University of Waterloo
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP