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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Waterloo
Sponsor:
Collaborator:
Advanced Vision Research
Information provided by (Responsible Party):
University of Waterloo
ClinicalTrials.gov Identifier:
NCT02014922
First received: December 12, 2013
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Study to Determine the Relief of Dry Eye Symptoms With the Use of TheraTears® Products

Resource links provided by NLM:


Further study details as provided by University of Waterloo:

Primary Outcome Measures:
  • Change over time of OSDI score [ Time Frame: At screening, 2 weeks, 1 month and 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change over time of Tear osmolarity [ Time Frame: At screening, 1 month and 3 months ] [ Designated as safety issue: No ]
  • Change over time of Tear film breakup time [ Time Frame: At screening, 1 month and 3 months ] [ Designated as safety issue: No ]
  • Change over time of Corneal staining [ Time Frame: At screening, 1 month and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change over time of Lid wiper epitheliopathy [ Time Frame: At screening, 1 month and 3 months ] [ Designated as safety issue: No ]
  • Change over time of Meibomian gland expressibility [ Time Frame: At screening, 1 month and 3 months ] [ Designated as safety issue: No ]
  • Change over time of Meibum quality [ Time Frame: At screening, 1 month and 3 months ] [ Designated as safety issue: No ]
  • Change over time of Tear film lipid layer thickness [ Time Frame: At screening, 1 month and 3 months ] [ Designated as safety issue: No ]
  • Change over time of Tear meniscus height [ Time Frame: At screening, 1 month and 3 months ] [ Designated as safety issue: No ]
  • Change over time of Schirmer's I scores [ Time Frame: At screening, 1 month and 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02014922

Contacts
Contact: Lyndon Jones, PhD 519-888-4065 lwjones@uwaterloo.ca
Contact: Sruthi Srinivasan, PhD 519-888-4567 ext 37311 s2srinivasan@uwaterloo.ca

Locations
Canada, Ontario
Centre for Contact Lens Research, University of Waterloo School of Optometry & Vision Science Recruiting
Waterloo, Ontario, Canada, N2L3G1
Contact: William Ngo, OD    519-888-4567 ext 31311    william.ngo@uwaterloo.ca   
Contact: Sruthi Srinivasan, PhD    519-888-4567 ext 37311    s2srinivasan@uwaterloo.ca   
Sub-Investigator: William Ngo, OD         
Sponsors and Collaborators
University of Waterloo
Advanced Vision Research
  More Information

No publications provided

Responsible Party: University of Waterloo
ClinicalTrials.gov Identifier: NCT02014922     History of Changes
Other Study ID Numbers: P/439/13/AVR
Study First Received: December 12, 2013
Last Updated: July 17, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Tetrahydrozoline
Carboxymethylcellulose Sodium
Vitamin E
Alpha-Tocopherol
Tocopherols
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Laxatives
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins

ClinicalTrials.gov processed this record on July 23, 2014