Clinical Trial

Comparison of Ocular Lubricants in People With Symptoms of Dry Eye

Study acronym: SPHINX
Recruiting Phase 4
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Summary
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.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-04-29
Trial Details
NCT Number NCT07451184
Lead Sponsor University of Waterloo
Collaborators: Alcon Research
Conditions Dry Eye Symptoms
Enrollment 100 participants
Start Date 2026-02-23
Primary Completion 2027-05-23 (estimated)
Study Completion 2027-05-23 (estimated)
Updated on ClinicalTrials.gov 2026-04-28