A Study to Determine the Relief of Dry Eye Symptoms With the Use of TheraTears® Products (DUNLIN) (DUNLIN)

• ClinicalTrials.gov Identifier: NCT02014922
• Recruitment Status: Completed
• First Posted: December 18, 2013
• Last Update Posted: March 11, 2015
• Sponsor: University of Waterloo
• Collaborator: Advanced Vision Research
• Information provided by (Responsible Party): University of Waterloo

Tracking Information

• First Submitted Date: December 12, 2013
• First Posted Date: December 18, 2013
• Last Update Posted Date: March 11, 2015
• Study Start Date: December 2013
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Determine the Relief of Dry Eye Symptoms With the Use of TheraTears® Products (DUNLIN)
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: Dry Eye Syndromes

Intervention

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

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 9, 2015): 33
• Original Estimated Enrollment (submitted: December 12, 2013): 40
• Actual Study Completion Date: November 2014
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02014922
• Other Study ID Numbers: P/439/13/AVR
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Waterloo
• Study Sponsor: University of Waterloo
• Collaborators: Advanced Vision Research
• Investigators: Not Provided
• PRS Account: University of Waterloo
• Verification Date: March 2015