Dry Eye SymptomsPhase 4SPHINXNCT07451184
Comparison of Ocular Lubricants in People With Symptoms of Dry Eye
A Phase 4 study testing Propylene glycol 0.6% and 3% trehalose and 0.15% sodium hyaluronate in people with Dry Eye Symptoms, run by University of Waterloo at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Symptoms
- What is being tested?
- Propylene glycol 0.6% and 3% trehalose and 0.15% sodium hyaluronate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 23 Feb 2026to 10 Aug 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 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;
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- Have an absence of active* anterior segment disease;
- 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;
- Are correctable to a visual acuity of +0.20 LogMAR or better (in at least one eye) with refraction results.
Who cannot join
- 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;
- Had any ocular injury or surgery within the 1 year prior to screening, nor have ocular surgery planned/ anticipated;
- Have biomicroscopy signs of grade 3 or more (Efron scale);
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- Have known sensitivity to the diagnostic pharmaceuticals or to any ingredients in the study products;
- Are pregnant, lactating or planning a pregnancy at the time of enrolment;
- Are a member of the Centre for Ocular Research \& Education directly involved in this study (on the delegation log);
- Are an employee of Alcon.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Ocular Research & Education (CORE)
Waterloo, Ontario, N2L 3G1
About this study
Official title: Symptomology Changes With Systane PRO PF Versus Thealoz Duo
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.
- Conditions
- Dry Eye Symptoms
- Being tested
- Propylene glycol 0.6%, 3% trehalose and 0.15% sodium hyaluronate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propylene glycol 0.6%Drug
1 drop per eye multiple times per day for 4 weeks
3% trehalose and 0.15% sodium hyaluronateDevice
1 drop per eye multiple times per day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Systane Pro PF/ Thealoz Duo | Experimental | Use of Systane Pro PF for 4 weeks, followed by use of Thealoz Duo for 4 weeks Receives: Drug: Propylene glycol 0.6%; Device: 3% trehalose and 0.15% sodium hyaluronate |
| Thealoz Duo / Systane Pro PF | Experimental | Use of Thealoz Duo for 4 weeks, followed by use of Systane Pro PF for 4 weeks Receives: Drug: Propylene glycol 0.6%; Device: 3% trehalose and 0.15% sodium hyaluronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference Ocular Surface Disease Index (OSDI) Score between Baseline and 4 Weeks
Within-subject difference in OSDI scores between baseline and after 4 weeks of use with each drop
Measured: From baseline (dispense) to 4 weeks of ocular lubricant use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start23 Feb 2026
- Primary completion10 Aug 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Jill Woods, MSc, MCOptom, Principal investigator, Centre for Ocular Research & Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451184
- Sponsor's protocol ID
- 47903
- Other IDs
- 98631981
- Acronym
- SPHINX
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptomology Changes With Systane PRO PF Versus Thealoz Duo
- ClinicalTrials.gov ID
- NCT07451184
- Acronym / sponsor ID
- SPHINX / 47903
- Conditions
- Dry Eye Symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 10 Aug 2026 (actual)
- Study completion
- 10 Aug 2026 (actual)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systane Pro PF/ Thealoz Duo | Experimental | Drug: Propylene glycol 0.6%, Device: 3% trehalose and 0.15% sodium hyaluronateUse of Systane Pro PF for 4 weeks, followed by use of Thealoz Duo for 4 weeks |
| Thealoz Duo / Systane Pro PF | Experimental | Drug: Propylene glycol 0.6%, Device: 3% trehalose and 0.15% sodium hyaluronateUse of Thealoz Duo for 4 weeks, followed by use of Systane Pro PF for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
- Have dry eye symptomatology as per Tear Film \& Ocular Surface Society Dry Eye WorkShop (TFOS DEWS) II definition:
Key exclusion criteria (10 listed)
- 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;
- Had any ocular injury or surgery within the 1 year prior to screening, nor have ocular surgery planned/ anticipated;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propylene glycol 0.6%1 drop per eye multiple times per day for 4 weeks | Drug | Systane Pro PF/ Thealoz Duo, Thealoz Duo / Systane Pro PF |
| 3% trehalose and 0.15% sodium hyaluronate1 drop per eye multiple times per day for 4 weeks | Device | Systane Pro PF/ Thealoz Duo, Thealoz Duo / Systane Pro PF |
Primary outcome
Difference Ocular Surface Disease Index (OSDI) Score between Baseline and 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Woods, MSc, MCOptom principal investigator
Centre for Ocular Research & Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propylene glycol 0.6% and 3% trehalose and 0.15% sodium hyaluronate in people with Dry Eye Symptoms, run by University of Waterloo at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference Ocular Surface Disease Index (OSDI) Score between Baseline and 4 Weeks (time frame: From baseline (dispense) to 4 weeks of ocular lubricant use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.