Dry EyeNCT05902364

Systane® Ultra Preservative Free Lubricant Eye Drops

A study testing Systane Ultra PF lubricant eye drops in people with Dry Eye, run by Alcon Research at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Ultra Preservative-Free (PF) in subjects experiencing dry eye symptoms (Group 1) and contact lens (CL) wearers experiencing discomfort due to CL-related dryness (Group 2). Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Dry Eye
What is being tested?: Systane Ultra PF lubricant eye drops
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 69 participants
Where: 4 sitesin 2 countries
Study dates: 28 Oct 2023to 14 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject must be able to understand and sign an informed consent form.
Subject with mild to moderate dry eye.
Subject with contact lens-related dry eye symptoms.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Has suffered any ocular injury to either eye in the past 3 months prior to screening.
Has undergone any other ocular surgery (including intraocular surgery) within the past 6 months or has any ocular surgery planned during the study.
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Canada2 sites

Integra Eye Care
Burnaby, British Columbia, V5E 1G3
University of Waterloo School of Optometry
Waterloo, Ontario, N2L 3G1

Other trials in Canada

New Zealand2 sites

Rose Optometry
Frankton, Otago, 3204
University of Auckland
Grafton, Auckland, 1142

Other trials in New Zealand

About this study

Read the detailed description

Subjects will participate in the study for approximately 30 days, with a phone call scheduled on Day 15 ± 2 (Visit 2) and a follow-up visit scheduled on Day 30 ± 2 (Visit 3). Subjects will be asked to complete patient questionnaires on Day 1 and at Visit 3 (Impact of Dry Eye on Everyday Life - Symptom Bother [IDEEL-SB] or Contact Lens Dry Eye Questionnaire [CLDEQ-8] and Comfortable Wear Time questions).

Conditions: Dry Eye
Being tested: Systane Ultra PF lubricant eye drops
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Systane Ultra PF lubricant eye dropsOther
Also called Systane Ultra Preservative-Free
Commercially available preservative free eye drops

Study groups in NCT05902364
Study group	Role	What they receive
Group 1 - Dry Eye Symptoms	Experimental	1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days Receives: Other: Systane Ultra PF lubricant eye drops
Group 2 - CL-Related Dryness Discomfort	Experimental	1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days Receives: Other: Systane Ultra PF lubricant eye drops

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Overall IDEEL SB Score - Group 1
The Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) module is a 20-item, patient-reported outcome questionnaire that assesses the subject's symptoms of dry eye. For each item, the subject selected a single response for both eyes, where 0 = "None of the time" (Q1) or "I did not have this symptom/Not Applicable" (Q2-20) to 4 = "All of the time" (Q1) or "Very Much" (Q2-20). The overall score was calculated as the mean value of the non-missing item scores (Q1-20) multiplied by 25 and ranged from 0 (minimum) to 100 (maximum). Baseline was defined as the last non-missing value prior to the start date of the study treatment. For subjects who were not exposed, Baseline was defined as the value from Visit 1 (Screening). Higher scores indicate greater symptom bother. No statistical hypothesis was pre-specified for this endpoint. This endpoint was pre-specified for Group 1
Measured: Baseline (Day 1), Day 30
Mean Overall CLDEQ-8 Score - Group 2
The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) is an 8-item, patient-reported outcome questionnaire that evaluates the severity of dry eye symptoms in soft contact lens wearers within the past 2 weeks. For each item, the subject selected a single response for both eyes using a 0-4, 0-5, or 1-6 Likert scale. The overall score was calculated as the sum of the numerical responses for each of the 8 items and ranged from 1 (minimum) to 37 (maximum). A lower CLDEQ-8 score indicates less frequent or less intense symptoms. Baseline was defined as the last non-missing value prior to the start date of the study treatment. For subjects who were not exposed, Baseline was defined as the value from Visit 1 (Screening). No statistical hypothesis is pre-specified for this endpoint. This endpoint was prespecified for Group 2 only.
Measured: Baseline (Day 1), Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 202314 Aug 2024

First posted15 Jun 2023
Study start28 Oct 2023
Primary completion14 Aug 2024
Study completion14 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry EyeStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 69 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05902364
Sponsor's protocol ID: DEU894-I001
Status last verified: Aug 2025
First submitted: 2 Jun 2023
Last updated: 27 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Systane® Ultra Preservative Free Lubricant Eye Drops
ClinicalTrials.gov ID: NCT05902364
Acronym / sponsor ID: DEU894-I001
Conditions: Dry Eye
Study type: Interventional
Recruitment status: Completed
Enrolment: 69 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 28 Oct 2023 (actual)
Primary completion: 14 Aug 2024 (actual)
Study completion: 14 Aug 2024 (actual)
First posted: 15 Jun 2023 (actual)
Results: Posted 27 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1 - Dry Eye Symptoms	Experimental	Other: Systane Ultra PF lubricant eye drops1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days
Group 2 - CL-Related Dryness Discomfort	Experimental	Other: Systane Ultra PF lubricant eye drops1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subject must be able to understand and sign an informed consent form.
Subject with mild to moderate dry eye.
Subject with contact lens-related dry eye symptoms.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (3 listed)

Has suffered any ocular injury to either eye in the past 3 months prior to screening.
Has undergone any other ocular surgery (including intraocular surgery) within the past 6 months or has any ocular surgery planned during the study.
Other protocol-defined exclusion criteria may apply.

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
Systane Ultra PF lubricant eye dropsAlso: Systane Ultra Preservative-FreeCommercially available preservative free eye drops	Other	Group 1 - Dry Eye Symptoms, Group 2 - CL-Related Dryness Discomfort

Primary outcome

Mean Overall IDEEL SB Score - Group 1
Time frame: Baseline (Day 1), Day 30
The Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) module is a 20-item, patient-reported outcome questionnaire that assesses the subject's symptoms of dry eye. For each item, the subject selected a single response for both eyes, where 0 = "None of the time" (Q1) or "I did not have this symptom/Not Applicable" (Q2-20) to 4 = "All of the time" (Q1) or "Very Much" (Q2-20). The overall score was calculated as the mean value of the non-missing item scores (Q1-20) multiplied by 25 and ranged from 0 (minimum) to 100 (maximum). Baseline was defined as the last non-missing value prior to the start date of the study treatment. For subjects who were not exposed, Baseline was defined as the value from Visit 1 (Screening). Higher scores indicate greater symptom bother. No statistical hypothesis was pre-specified for this endpoint. This endpoint was pre-specified for Group 1
Mean Overall CLDEQ-8 Score - Group 2
Time frame: Baseline (Day 1), Day 30
The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) is an 8-item, patient-reported outcome questionnaire that evaluates the severity of dry eye symptoms in soft contact lens wearers within the past 2 weeks. For each item, the subject selected a single response for both eyes using a 0-4, 0-5, or 1-6 Likert scale. The overall score was calculated as the sum of the numerical responses for each of the 8 items and ranged from 1 (minimum) to 37 (maximum). A lower CLDEQ-8 score indicates less frequent or less intense symptoms. Baseline was defined as the last non-missing value prior to the start date of the study treatment. For subjects who were not exposed, Baseline was defined as the value from Visit 1 (Screening). No statistical hypothesis is pre-specified for this endpoint. This endpoint was prespecified for Group 2 only.

Results and safety

Results posted to the registry on 27 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 - Dry Eye Symptoms	34	33
Group 2 - CL-Related Dryness Discomfort	34	34

Primary outcome: Mean Overall IDEEL SB Score - Group 1

Time frame: Baseline (Day 1), Day 30. Mean (Standard Deviation). Unit: score on a scale

Measure	Group 1 - Dry Eye Symptoms n = 33
Day 1	45.53 (11.784)
Day 30	31.23 (10.854)

Population analysed: Full Analysis Set with data at visit

Primary outcome: Mean Overall CLDEQ-8 Score - Group 2

Time frame: Baseline (Day 1), Day 30. Mean (Standard Deviation). Unit: score on a scale

Measure	Group 2 - CL-Related Dryness Discomfort n = 34
Day 1	19.4 (5.84)
Day 30	10.3 (4.64)

Population analysed: Full Analysis Set

Adverse events

Time frame: Adverse events (AEs) were collected from time of consent until study exit, approximately one month. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects. This analysis population includes all subjects/eyes exposed to any study lenses, as treated.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 - Ocular Adverse Events	0 of 68 (0%)	0 of 68 (0%)	0
Group 1 - Nonocular Adverse Events	0 of 34 (0%)	2 of 34 (5.9%)	0 of 34
Group 2 - Ocular Adverse Events	0 of 68 (0%)	0 of 68 (0%)	0
Group 2 - Nonocular Adverse Events	0 of 34 (0%)	1 of 34 (2.9%)	0 of 34

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Clinical Lead, Vision Care study director

Alcon Research, LLC

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Systane Ultra PF lubricant eye drops in people with Dry Eye, run by Alcon Research at 4 sites in 2 countries.

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 4 inclusion and 3 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 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada, New Zealand. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Mean Overall IDEEL SB Score - Group 1 (time frame: Baseline (Day 1), Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05902364.

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 27 Aug 2025.