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

NCT02014922 | Completed Phase 4

• 1 other identifier: P/439/13/AVR
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• 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

Study Arms (2)

Control

NO INTERVENTION

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

Treatment

EXPERIMENTAL

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

Interventions

TheraTears® Lubricant Eye Drop DRUG

Treatment

TheraTears® preservative-free single-use containers DRUG

Treatment

TheraTears® Nutrition DIETARY_SUPPLEMENT

Treatment

TheraTears® TheraLid® Eyelid Cleanser OTHER

Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Waterloo: lead
• Advanced Vision Research: collaborator

Study Sites (1)

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

Waterloo, Ontario, N2L3G1, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: December 18, 2013
• Study Start: December 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 11, 2015

Record last verified: 2015-03

Locations

CA (1)