Comparison of Ocular Lubricants in People With Symptoms of Dry Eye

Symptomology Changes With Systane PRO PF Versus Thealoz Duo

Comparison of Ocular Lubricants in People With Symptoms of Dry Eye (NCT07451184) is a Phase 4 interventional studying Dry Eye Symptoms, sponsored by University of Waterloo. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Dry Eye Symptoms subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Are at least 18 years of age and have full legal capacity to volunteer; 2. Have understood and signed an institutional review board (IRB)/ independent ethics committee (IEC) approved willing to sign a consent form form; 3. Are willing and able to attend all study visits as required per protocol; 4. Are willing to discontinue use of all habitual artificial tear supplements and use only the study drops as directed for the entire study duration; 5. Have dry eye symptomatology as per Tear Film \& Ocular Surface Society Dry Eye WorkShop (TFOS DEWS) II definition: - Have an Ocular Surface Disease Index (OSDI) score ≥13; 6. Have an absence of active\* anterior segment disease; 7. Have not worn contact lenses for the previous 14 days before screening, and are willing to not wear contact lenses for the duration of the study; 8. Are correctable to a visual acuity of +0.20 LogMAR or better (in at least one eye) with refraction results. Who Should NOT Join This Trial: 1. Have taken part in an interventional clinical study within the previous 14 days before screening; 2. Are participating in any concurrent ocular or interventional clinical trial; 3. Have any active\* ocular inflammation, infection, or are using ocular topical treatment (other than dry eye drops); 4. 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; 5. Had any ocular injury or surgery within the 1 year prior to screening, nor have ocular surgery planned/ anticipated; 6. Have biomicroscopy signs of grade 3 or more (Efron scale); 7. Have known sensitivity to the diagnostic pharmaceuticals or to any ingredients in the study products; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Are at least 18 years of age and have full legal capacity to volunteer; 2. Have understood and signed an institutional review board (IRB)/ independent ethics committee (IEC) approved informed consent form; 3. Are willing and able to attend all study visits as required per protocol; 4. Are willing to discontinue use of all habitual artificial tear supplements and use only the study drops as directed for the entire study duration; 5. Have dry eye symptomatology as per Tear Film \& Ocular Surface Society Dry Eye WorkShop (TFOS DEWS) II definition: * Have an Ocular Surface Disease Index (OSDI) score ≥13; 6. Have an absence of active\* anterior segment disease; 7. Have not worn contact lenses for the previous 14 days before screening, and are willing to not wear contact lenses for the duration of the study; 8. Are correctable to a visual acuity of +0.20 LogMAR or better (in at least one eye) with refraction results. Exclusion Criteria: 1. Have taken part in an interventional clinical study within the previous 14 days before screening; 2. Are participating in any concurrent ocular or interventional clinical trial; 3. Have any active\* ocular inflammation, infection, or are using ocular topical treatment (other than dry eye drops); 4. 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; 5. Had any ocular injury or surgery within the 1 year prior to screening, nor have ocular surgery planned/ anticipated; 6. Have biomicroscopy signs of grade 3 or more (Efron scale); 7. Have known sensitivity to the diagnostic pharmaceuticals or to any ingredients in the study products; 8. Are pregnant, lactating or planning a pregnancy at the time of enrolment; 9. Are a member of the Centre for Ocular Research \& Education directly involved in this study (on the delegation log); 10. Are an employee of Alcon.

Treatments Being Tested

DRUG

Propylene glycol 0.6%

1 drop per eye multiple times per day for 4 weeks

DEVICE

3% trehalose and 0.15% sodium hyaluronate

1 drop per eye multiple times per day for 4 weeks

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Centre for Ocular Research & Education (CORE)

Waterloo, Ontario, Canada

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07451184), the sponsor (University of Waterloo), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07451184 clinical trial studying?

Who can participate in NCT07451184?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07451184?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07451184. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07451184. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.