Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07451184

Comparison of Ocular Lubricants in People With Symptoms of Dry Eye

Led by University of Waterloo · Updated on 2026-04-28

100

Participants Needed

1

Research Sites

64 weeks

Total Duration

On this page

Sponsors

U

University of Waterloo

Lead Sponsor

A

Alcon Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

Ocular dryness and discomfort are symptoms commonly associated with dry eye. Lubricating eye drops, also called artificial tears, are often used to moisten the eye and provide relief from these symptoms. There are currently several types of lubricating eye drops available, differing in their ingredients, consistency, and recommended frequency of application. The aim of this study is to compare the effectiveness of two lubricating eye drops that differ in their ingredients and recommended frequency of application. The goal is to see whether they perform the same or if one of them provides better relief for people with dry eye symptoms. One of the eye drops is commercially available in Canada, the other one is not commercially available in Canada and therefore considered an investigational eye drop. This eye drop is available in the United States of America. In this study, participants will use one drop twice per day and the other drop four times per day. Each product will be used for 4 weeks and all participants will use both products (one after the other). There will be a 2-week period of no drops between the two study products. Before starting each drop and after 4 weeks of drop use, we will assess the eyes of the participants and ask them how their eyes feel. Participants will also be asked to answer a series of questions regarding the drops. Participants will encounter procedures that they normally experience in an eye care setting. The results will help the funding company to better understand the performance of the products used in this study. It may also help eyecare practitioners in managing their patients with dry eye symptoms. The hypothesis is that the drop used twice a day will be non-inferior to the drop used 4 times per day for the change in dry eye symptoms (assessed with the Ocular Surface Disease Index questionnaire) after 4 weeks of use.

CONDITIONS

Official Title

Comparison of Ocular Lubricants in People With Symptoms of Dry Eye

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age with full legal capacity to participate
  • Signed an approved informed consent form
  • Willing and able to attend all study visits
  • Willing to stop all habitual artificial tear use and use only the study drops during the study
  • Have dry eye symptoms with an Ocular Surface Disease Index (OSDI) score of 13 or higher
  • No active anterior segment eye disease
  • Have not worn contact lenses for 14 days before screening and willing to avoid them during the study
  • Correctable to visual acuity of +0.20 LogMAR or better in at least one eye with refraction results
Not Eligible

You will not qualify if you...

  • Participated in another interventional clinical study within 14 days before screening
  • Currently involved in any other ocular or interventional clinical trial
  • Have active ocular inflammation, infection, or using ocular topical treatment other than dry eye drops
  • Started systemic medications known to cause dry eye within 30 days before screening (stable dosing for over 30 days allowed)
  • Had ocular injury or surgery within 1 year before screening or have planned ocular surgery
  • Show signs of grade 3 or higher on the Efron biomicroscopy scale
  • Known sensitivity to study product ingredients or diagnostic pharmaceuticals
  • Pregnant, lactating, or planning pregnancy at enrollment
  • Member of the Centre for Ocular Research & Education involved in this study
  • Employee of Alcon

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Centre for Ocular Research & Education (CORE)

Waterloo, Ontario, Canada, N2L 3G1

Actively Recruiting

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Research Team

J

Julia Jones

CONTACT

J

Jill Woods, MSc, MCOptom

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Comparison of Ocular Lubricants in People With Symptoms of Dry Eye | DecenTrialz