Dry EyeNCT05932238
Systane® Hydration PF and Systane® Hydration Preserved
A study testing Polyethylene glycol 400 and propylene glycol solution/drops - Preservative Free (PF) and Polyethylene glycol 400 and propylene glycol solution/drops - Preserved in people with Dry Eye, run by Alcon Research at 3 sites in Canada.
Trial summary
The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Hydration Preservative Free (PF) in subjects experiencing dry eye symptoms (Group 1) and in contact lens (CL) wearers experiencing discomfort due to CL-related dryness (Group 2) and also Systane Hydration… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Polyethylene glycol 400 and propylene glycol solution/drops - Preservative Free (PF) and Polyethylene glycol 400 and propylene glycol solution/drops - Preserved
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 3 sitesCanada
- Study dates
- 6 Oct 2023to 5 Sep 2024
- Phase
- Interventional
- 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
- Subject must be able to understand and sign an informed consent form
- Subject with mild to moderate dry eye
- Subject with CL-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
3 sites in 1 country.
Canada3 sites
Aggarwal and Associates Limited
Brampton, Ontario, L6T 0G1
Integra Eye Care
Burnaby, British Columbia, V5E 1G3
University of Waterloo School of Optometry
Waterloo, Ontario, N2L 3G1
About this study
The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Hydration Preservative Free (PF) in subjects experiencing dry eye symptoms (Group 1) and in contact lens (CL) wearers experiencing discomfort due to CL-related dryness (Group 2) and also Systane Hydration Preserved in CL wearers experiencing discomfort due to CL-related dryness (Group 3). Statistical analyses will be presented by group.
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
- Polyethylene glycol 400 and propylene glycol solution/drops - Preservative Free (PF), Polyethylene glycol 400 and propylene glycol solution/drops - Preserved
- 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.
Polyethylene glycol 400 and propylene glycol solution/drops - Preservative Free (PF)Other
Also called Systane Hydration Preservative Free (PF)
commercially available eye drops
Polyethylene glycol 400 and propylene glycol solution/drops - PreservedOther
Also called Systane Hydration Preserved
commercially available eye drops
| Study group | Role | What they receive |
|---|---|---|
| Systane Hydration Preservative Free (PF) | Experimental | 1-2 drops in each eye four times a day for 30 days Receives: Other: Polyethylene glycol 400 and propylene glycol solution/drops - Preservative Free (PF) |
| Systane Hydration Preserved | Experimental | 1-2 drops in each eye four times a day for 30 days Receives: Other: Polyethylene glycol 400 and propylene glycol solution/drops - Preserved |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean overall IDEEL-Symptom Bother(SB) score - Group 1
The IDEEL-SB (Version 1) symptom bother module consists of 20 questions that assess general dry eye symptoms a subject experiences. The subject will be instructed to select a single response that best represents their answer. The Symptom Bother score is calculated as the mean value of the non-missing item scores 1-20 multiplied by 25. No statistical hypothesis is pre-specified for this endpoint.
Measured: Visit 3 (Day 30)
Resultant overall CLDEQ-8 score - Group 2 and Group 3
The CLDEQ-8 is an eight-item questionnaire that evaluates the severity of dry eye symptoms in soft contact lens wearers within the past 2 weeks. Each question is answered using a 0-4, 0-5, or 1-6 Likert scale for a resultant overall score of 1-37. No statistical hypothesis is pre-specified for this endpoint.
Measured: Visit 3 (Day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start6 Oct 2023
- Primary completion5 Sep 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Lead, Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932238
- Sponsor's protocol ID
- DEN923-I001
- Status last verified
- Sep 2024
- First submitted
- 27 Jun 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systane® Hydration PF and Systane® Hydration Preserved
- ClinicalTrials.gov ID
- NCT05932238
- Acronym / sponsor ID
- DEN923-I001
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 5 Sep 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 6 Jul 2023 (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.
The purpose of this post-market clinical follow-up (PMCF) study is to assess the performance and safety of Systane Hydration Preservative Free (PF) in subjects experiencing dry eye symptoms (Group 1) and in contact lens (CL) wearers experiencing discomfort due to CL-related dryness (Group 2) and also Systane Hydration Preserved in CL wearers experiencing discomfort due to CL-related dryness (Group 3). Statistical analyses will be presented by group.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systane Hydration Preservative Free (PF) | Experimental | Other: Polyethylene glycol 400 and propylene glycol solution/drops - Preservative Free (PF)1-2 drops in each eye four times a day for 30 days |
| Systane Hydration Preserved | Experimental | Other: Polyethylene glycol 400 and propylene glycol solution/drops - Preserved1-2 drops in each eye four times a day for 30 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not 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 CL-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 |
|---|---|---|
| Polyethylene glycol 400 and propylene glycol solution/drops - Preservative Free (PF)Also: Systane Hydration Preservative Free (PF)commercially available eye drops | Other | Systane Hydration Preservative Free (PF) |
| Polyethylene glycol 400 and propylene glycol solution/drops - PreservedAlso: Systane Hydration Preservedcommercially available eye drops | Other | Systane Hydration Preserved |
Primary outcome
Mean overall IDEEL-Symptom Bother(SB) score - Group 1
Time frame: Visit 3 (Day 30)
The IDEEL-SB (Version 1) symptom bother module consists of 20 questions that assess general dry eye symptoms a subject experiences. The subject will be instructed to select a single response that best represents their answer. The Symptom Bother score is calculated as the mean value of the non-missing item scores 1-20 multiplied by 25. No statistical hypothesis is pre-specified for this endpoint.
Resultant overall CLDEQ-8 score - Group 2 and Group 3
Time frame: Visit 3 (Day 30)
The CLDEQ-8 is an eight-item questionnaire that evaluates the severity of dry eye symptoms in soft contact lens wearers within the past 2 weeks. Each question is answered using a 0-4, 0-5, or 1-6 Likert scale for a resultant overall score of 1-37. No statistical hypothesis is pre-specified for this endpoint.
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 19 Sep 2024.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyethylene glycol 400 and propylene glycol solution/drops - Preservative Free (PF) and Polyethylene glycol 400 and propylene glycol solution/drops - Preserved in people with Dry Eye, run by Alcon Research at 3 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 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
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?
Mean overall IDEEL-Symptom Bother(SB) score - Group 1 (time frame: Visit 3 (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?
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 19 Sep 2024.