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

Dry Eye Syndromes Clinical Trial

— DUNLIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02014922
• Other study ID #: P/439/13/AVR
• Status: Completed
• Phase: Phase 4
• First received: December 12, 2013
• Last updated: March 9, 2015
• Start date: December 2013
• Est. completion date: November 2014

Study information

• Verified date: March 2015
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• TheraTears® Lubricant Eye Drop

• TheraTears® preservative-free single-use containers

Dietary Supplement:
• TheraTears® Nutrition

Other:
• TheraTears® TheraLid® Eyelid Cleanser

Locations

Country	Name	City	State
Canada	Centre for Contact Lens Research, University of Waterloo School of Optometry & Vision Science	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Waterloo	Advanced Vision Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change over time of OSDI score	Ocular Surface Disease Index (OSDI) questionnaire score	At screening, 2 weeks, 1 month and 3 months	No
Primary	Change over time of Visual analogue scores		At screening, 2 weeks, 1 month and 3 months	No
Primary	Change over time of Tear osmolarity		At screening, 1 month and 3 months	No
Primary	Change over time of Tear film breakup time		At screening, 1 month and 3 months	No
Primary	Change over time of Corneal staining		At screening, 1 month and 3 months	No
Secondary	Change over time of Lid wiper epitheliopathy		At screening, 1 month and 3 months	No
Secondary	Change over time of Meibomian gland expressibility		At screening, 1 month and 3 months	No
Secondary	Change over time of Meibum quality		At screening, 1 month and 3 months	No
Secondary	Change over time of Tear film lipid layer thickness		At screening, 1 month and 3 months	No
Secondary	Change over time of Tear meniscus height		At screening, 1 month and 3 months	No
Secondary	Change over time of Schirmer's I scores		At screening, 1 month and 3 months	No