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

Primary Purpose

Dry Eye Syndromes

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

TheraTears® Lubricant Eye Drop

TheraTears® preservative-free single-use containers

TheraTears® Nutrition

TheraTears® TheraLid® Eyelid Cleanser

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Is between 18 and 65 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Exhibits symptoms of dry eye for at least 3 months;
Has an OSDI score of ≥ 23;
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;
Has an average non-invasive tear breakup time ≤ 5.00 seconds in at least one eye.

Exclusion Criteria:

Is participating in any concurrent clinical or research study;
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.
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
Is pregnant, lactating or planning a pregnancy at the time of enrollment, as determined verbally;
Is aphakic;
Has undergone refractive error surgery;
Has taken part in another (pharmaceutical) research study within the last 30 days;
Has worn contact lenses within the past 5 years;
Is currently using or have used omega 3 supplements in the past 3 months.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Treatment

Arm Description

Participants randomized to the control group will be allowed to continue using their habitual artificial tears, and / or additional habitual concurrent dry eye treatments.

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

Outcomes

Primary Outcome Measures

Change over time of OSDI score

Ocular Surface Disease Index (OSDI) questionnaire score

Change over time of Visual analogue scores

Change over time of Tear osmolarity

Change over time of Tear film breakup time

Change over time of Corneal staining

Secondary Outcome Measures

Change over time of Lid wiper epitheliopathy

Change over time of Meibomian gland expressibility

Change over time of Meibum quality

Change over time of Tear film lipid layer thickness

Change over time of Tear meniscus height

Change over time of Schirmer's I scores

Full Information

NCT ID

NCT02014922

First Posted

December 12, 2013

Last Updated

March 9, 2015

Sponsor

University of Waterloo

Collaborators

Advanced Vision Research

1. Study Identification

Unique Protocol Identification Number

NCT02014922

Brief Title

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

Acronym

DUNLIN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Waterloo

Collaborators

Advanced Vision Research

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndromes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

No Intervention

Arm Description

Participants randomized to the control group will be allowed to continue using their habitual artificial tears, and / or additional habitual concurrent dry eye treatments.

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

TheraTears® Lubricant Eye Drop

Intervention Type

Drug

Intervention Name(s)

TheraTears® preservative-free single-use containers

Intervention Type

Dietary Supplement

Intervention Name(s)

TheraTears® Nutrition

Intervention Type

Other

Intervention Name(s)

TheraTears® TheraLid® Eyelid Cleanser

Primary Outcome Measure Information:

Title

Change over time of OSDI score

Description

Ocular Surface Disease Index (OSDI) questionnaire score

Time Frame

At screening, 2 weeks, 1 month and 3 months

Title

Change over time of Visual analogue scores

Time Frame

At screening, 2 weeks, 1 month and 3 months

Title

Change over time of Tear osmolarity

Time Frame