Dry EyeNCT05932225

Systane® Complete Preservative Free Lubricant Eye Drops

A study testing Propylene glycol solution/drops in people with Dry Eye, run by Alcon Research at 4 sites in Canada.

Completed

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

Trial summary

The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Complete Preservative Free (PF) lubricant eye drops in subjects experiencing dry eye symptoms. Statistical analyses will be presented overall and by Dry Eye Disease (DED) group. 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?: Propylene glycol solution/drops
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 4 sitesCanada
Study dates: 18 Aug 2023to 20 Feb 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
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 1 country.

Canada4 sites

Aggarwal and Associates Limited
Brampton, Ontario, L6T 0G1
Integra Eye Care
Burnaby, British Columbia, V5E 1G3
Eyes on Sheppard Clinic
North York, Ontario, M2N 3A1
University of Waterloo Centre for Contact Lens Research
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

Read the detailed description

Subjects will participate in the study for approximately 30 days, with a Screening/Baseline visit scheduled on Day 1, 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 the Impact of Dry Eye on Everyday Life - Symptom Bother [IDEEL-SB]) questionnaire on Day 1 and Visit 3. In addition, subjects will be instructed to document Systane Complete PF dosing information on a daily basis using a subject diary.

Conditions: Dry Eye
Being tested: Propylene glycol solution/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.

Propylene glycol solution/dropsOther
Also called Systane Complete Preservative-Free
Commercially available eye drops

Study groups in NCT05932225
Study group	Role	What they receive
Systane Complete Preservative-Free	Experimental	1-2 drops in each eye four times a day for 30 days Receives: Other: Propylene glycol solution/drops

What is being measured

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

Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - By Dry Eye Group
The IDEEL SB module is a 20-question, patient-reported outcome questionnaire that assesses the subject's symptoms of dry eye. For each question, 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 Symptom Bother score was calculated as the mean value of the non-missing item scores (Q1-20) multiplied by 25, for an overall resultant score ranging from 0 to 100. Higher scores indicate greater symptom bother. No statistical hypothesis was pre-specified for this endpoint.
Measured: Baseline (Day 1 pretreatment), Day 30
Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - All Subjects
The IDEEL SB module is a 20-question, patient-reported outcome questionnaire that assesses the subject's symptoms of dry eye. For each question, 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 Symptom Bother score was calculated as the mean value of the non-missing item scores (Q1-20) multiplied by 25, for an overall resultant score ranging from 0 to 100. Higher scores indicate greater symptom bother. No statistical hypothesis was pre-specified for this endpoint.
Measured: Baseline (Day 1 pretreatment), Day 30

Timeline

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

18 Aug 202320 Feb 2024

First posted6 Jul 2023
Study start18 Aug 2023
Primary completion20 Feb 2024
Study completion20 Feb 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: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05932225
Sponsor's protocol ID: DEC262-I001
Status last verified: Mar 2025
First submitted: 27 Jun 2023
Last updated: 4 Apr 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 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Systane® Complete Preservative Free Lubricant Eye Drops
ClinicalTrials.gov ID: NCT05932225
Acronym / sponsor ID: DEC262-I001
Conditions: Dry Eye
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 18 Aug 2023 (actual)
Primary completion: 20 Feb 2024 (actual)
Study completion: 20 Feb 2024 (actual)
First posted: 6 Jul 2023 (actual)
Results: Posted 4 Apr 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: 1

Arm	Type	Receives
Systane Complete Preservative-Free	Experimental	Other: Propylene glycol solution/drops1-2 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 (3 listed)

Subject must be able to understand and sign an informed consent form
Subject with mild to moderate dry eye
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
Propylene glycol solution/dropsAlso: Systane Complete Preservative-FreeCommercially available eye drops	Other	Systane Complete Preservative-Free

Primary outcome

Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - By Dry Eye Group
Time frame: Baseline (Day 1 pretreatment), Day 30
The IDEEL SB module is a 20-question, patient-reported outcome questionnaire that assesses the subject's symptoms of dry eye. For each question, 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 Symptom Bother score was calculated as the mean value of the non-missing item scores (Q1-20) multiplied by 25, for an overall resultant score ranging from 0 to 100. Higher scores indicate greater symptom bother. No statistical hypothesis was pre-specified for this endpoint.
Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - All Subjects
Time frame: Baseline (Day 1 pretreatment), Day 30
The IDEEL SB module is a 20-question, patient-reported outcome questionnaire that assesses the subject's symptoms of dry eye. For each question, 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 Symptom Bother score was calculated as the mean value of the non-missing item scores (Q1-20) multiplied by 25, for an overall resultant score ranging from 0 to 100. Higher scores indicate greater symptom bother. No statistical hypothesis was pre-specified for this endpoint.

Results and safety

Results posted to the registry on 4 Apr 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
Aqueous Deficient Dry Eye	14	13
Evaporative Dry Eye	32	29
Mixed Dry Eye	22	22

Primary outcome: Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - By Dry Eye Group

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

Measure	Aqueous Deficient Dry Eye n = 14	Evaporative Dry Eye n = 32	Mixed Dry Eye n = 22
Baseline (Day 1 pretreatment)	41.36 (11.095)	47.08 (12.689)	47.63 (11.756)
Day 30	31.26 (9.449)	32.16 (11.080)	32.91 (10.016)

Population analysed: Full Analysis Set: All subjects/eyes exposed to at least one dose of Systane Complete PF with data at visit

Primary outcome: Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - All Subjects

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

Measure	Systane Complete PF n = 68
Baseline (Day 1 pretreatment)	46.08 (12.150)
Day 30	32.24 (10.265)

Population analysed: Full Analysis Set: All subjects/eyes exposed to at least one dose of Systane Complete PF with data at visit

Adverse events

Time frame: Adverse events (AEs) were collected from time of consent until study exit. The total expected duration of participation for each subject was approximately 30 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pretreatment	0 of 68 (0%)	0 of 68 (0%)	0 of 68
Aqueous Deficient Dry Eye - Ocular	0 of 28 (0%)	0 of 28 (0%)	0 of 28
Aqueous Deficient Dry Eye - Nonocular	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Evaporative Dry Eye - Ocular	0 of 64 (0%)	0 of 64 (0%)	0 of 64
Evaporative Dry Eye - Nonocular	0 of 32 (0%)	0 of 32 (0%)	0 of 32
Mixed Dry Eye - Ocular	0 of 44 (0%)	0 of 44 (0%)	0 of 44
Mixed Dry Eye - Nonocular	0 of 22 (0%)	0 of 22 (0%)	0 of 22
Overall - Ocular	0 of 136 (0%)	0 of 136 (0%)	0 of 136
Overall - Nonocular	0 of 68 (0%)	0 of 68 (0%)	0 of 68

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 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 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Propylene glycol solution/drops in people with Dry Eye, run by Alcon Research at 4 sites 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 3 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 4 Apr 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. 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 4 Apr 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 Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - By Dry Eye Group (time frame: Baseline (Day 1 pretreatment), 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 NCT05932225.

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 4 Apr 2025.