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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: TheraTears® Lubricant Eye Drop; Drug: TheraTears® preservative-free single-use containers; Dietary supplement: TheraTears® Nutrition; Other: TheraTears® TheraLid® Eyelid Cleanser

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L3G1
      • Centre for Contact Lens Research, University of Waterloo School of Optometry & Vision Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change over time of OSDI score	Ocular Surface Disease Index (OSDI) questionnaire score	At screening, 2 weeks, 1 month and 3 months
Change over time of Visual analogue scores		At screening, 2 weeks, 1 month and 3 months
Change over time of Tear osmolarity		At screening, 1 month and 3 months
Change over time of Tear film breakup time		At screening, 1 month and 3 months
Change over time of Corneal staining		At screening, 1 month and 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change over time of Lid wiper epitheliopathy	At screening, 1 month and 3 months
Change over time of Meibomian gland expressibility	At screening, 1 month and 3 months
Change over time of Meibum quality	At screening, 1 month and 3 months
Change over time of Tear film lipid layer thickness	At screening, 1 month and 3 months
Change over time of Tear meniscus height	At screening, 1 month and 3 months
Change over time of Schirmer's I scores	At screening, 1 month and 3 months

Collaborators and Investigators

• Sponsor: University of Waterloo
• Collaborators: Advanced Vision Research

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: December 12, 2013
• First Submitted That Met QC Criteria: December 12, 2013
• First Posted (Estimate): December 18, 2013

Study Record Updates

• Last Update Posted (Estimate): March 11, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Protective Agents; Micronutrients; Vitamins; Antioxidants; Pharmaceutical Solutions; Laxatives; Ophthalmic Solutions; Vitamin E; Tocopherols; alpha-Tocopherol; Lubricant Eye Drops; Carboxymethylcellulose Sodium
• Other Study ID Numbers: P/439/13/AVR