Centre for Ocular Research & Education (CORE)
Waterloo, Ontario, N2L 3G1, Canada
Location status: Recruiting
Location contact
Jill Woods, MSc, MCOptom
CONTACT
1-519-888-4567 ext. 36743
Jill Woods, MSc, MCOptom
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07451184
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Waterloo, Ontario, N2L 3G1, Canada
Location status: Recruiting
Jill Woods, MSc, MCOptom
CONTACT
1-519-888-4567 ext. 36743
Jill Woods, MSc, MCOptom
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 drop per eye multiple times per day for 4 weeks
1 drop per eye multiple times per day for 4 weeks
Time frame: From baseline (dispense) to 4 weeks of ocular lubricant use
Within-subject difference in OSDI scores between baseline and after 4 weeks of use with each drop
Contact information is provided by the study sponsor or research team.
University of Waterloo
Other
Symptomology Changes With Systane PRO PF Versus Thealoz Duo
Acronym: SPHINX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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