Comparing two lubricating eye drops for dry eye symptoms

Symptomology Changes With Systane PRO PF Versus Thealoz Duo

This study will try two different lubricating eye drops — one used twice daily and one used four times daily — to see which gives better relief for adults with dry eye symptoms.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Waterloo (Academic / other)
• Locations: 1 site (Waterloo, Ontario)
• Trial ID: NCT07451184 on ClinicalTrials.gov

What this trial studies

Adults with dry eye symptoms will stop their usual artificial tears and use only the study drops, trying one product on a twice-daily schedule and the other on a four-times-daily schedule for equal treatment periods. The two products differ in ingredients and availability: one is commercially available in Canada and the other is not available in Canada but is marketed in the United States. Eligible participants must have symptomatic dry eye (OSDI ≥13), no active anterior segment disease, meet visual acuity criteria, and agree to avoid contact lens wear during the study. Study visits are conducted in person at the Centre for Ocular Research & Education (CORE) in Waterloo, Ontario under a Phase 4 interventional protocol.

Who should consider this trial

Good fit: Ideal candidates are adults (age ≥18) with symptomatic dry eye (OSDI ≥13) who can attend site visits, stop other artificial tears, and refrain from contact lens wear for the study duration.

Not a fit: People with active anterior segment eye disease, those unable to discontinue their current eye-drop regimen, regular contact lens wearers, or those who do not meet the visual acuity or age criteria are unlikely to benefit from this study.

Why it matters

Potential benefit: If one drop provides better or longer-lasting relief or works with less frequent dosing, patients could have improved symptom control or a simpler dosing routine.

How similar studies have performed: Previous trials comparing artificial tears, including formulations containing hyaluronate and trehalose, have shown modest symptomatic benefits, so this comparative approach is not novel.

Eligibility criteria

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.

Where this trial is running

Waterloo, Ontario

• Centre for Ocular Research & Education (CORE) — Waterloo, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Jill Woods, MSc, MCOptom — Centre for Ocular Research & Education
• Study coordinator: Julia Jones

Conditions Dry Eye Symptoms