About 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.
Eligibility criteria
Qualifiers
Are at least 18 years of age and have full legal capacity to volunteer;
Have understood and signed an institutional review board (IRB)/ independent ethics committee (IEC) approved informed consent form;
Are willing and able to attend all study visits as required per protocol;
Are willing to discontinue use of all habitual artificial tear supplements and use only the study drops as directed for the entire study duration;
Disqualifiers
Have taken part in an interventional clinical study within the previous 14 days before screening;
Are participating in any concurrent ocular or interventional clinical trial;
Have any active* ocular inflammation, infection, or are using ocular topical treatment (other than dry eye drops);
Started any systemic medication known to cause dry eye (e.g., anti-histamine, antidepressants, benzodiazepines, etc.) within 30 days before screening. Stable dosing for >30 days before screening is allowed, but changes (including commencing new) of dosing of such medication within the study period would lead to early exit from the study;
Trial design
Treatments tested in this trial
- Propylene glycol 0.6%
- 3% trehalose and 0.15% sodium hyaluronate
Treatment groups
Sponsors and collaborators
University of Waterloo
Lead sponsor
Alcon Research
Collaborator