Ocular Lubricants for Dry Eye Syndrome
(SPHINX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Jill Woods, MSc, MCOptom
Principal Investigator
Centre for Ocular Research & Education
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase 1
Participants use Systane Pro PF for 4 weeks, with assessments before and after the treatment period
Washout Period
A 2-week period with no eye drops to clear the effects of the first treatment
Treatment Phase 2
Participants use Thealoz Duo for 4 weeks, with assessments before and after the treatment period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Comparison of Ocular Lubricants
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Use of Thealoz Duo for 4 weeks, followed by use of Systane Pro PF for 4 weeks
Use of Systane Pro PF for 4 weeks, followed by use of Thealoz Duo for 4 weeks
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Waterloo
Lead Sponsor
Alcon Research
Industry Sponsor
Raquel C. Bono
Alcon Research
Chief Medical Officer since 2022
MD from Harvard Medical School
David Endicott
Alcon Research
Chief Executive Officer since 2018
MBA from University of Southern California
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