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

NCT ID: NCT02014922

Last Updated: 2015-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-11-30

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.

Conditions

Dry Eye Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

TheraTears® Lubricant Eye Drop

Intervention Type: DRUG

TheraTears® preservative-free single-use containers

Intervention Type: DRUG

TheraTears® Nutrition

Intervention Type: DIETARY_SUPPLEMENT

TheraTears® TheraLid® Eyelid Cleanser

Intervention Type: OTHER

Interventions

TheraTears® Lubricant Eye Drop

Intervention Type: DRUG

TheraTears® preservative-free single-use containers

Intervention Type: DRUG

TheraTears® Nutrition

Intervention Type: DIETARY_SUPPLEMENT

TheraTears® TheraLid® Eyelid Cleanser

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Advanced Vision Research

INDUSTRY

Sponsor Role: collaborator

University of Waterloo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre for Contact Lens Research, University of Waterloo School of Optometry & Vision Science

Waterloo, Ontario, Canada

Countries

Canada

Other Identifiers

P/439/13/AVR

Identifier Type: -

Identifier Source: org_study_id