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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). Statistical analyses will be presented by group. This study will be conducted in Canada, Australia, and New Zealand.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systane Ultra PF lubricant eye drops | Other | Commercially available preservative free eye drops |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Baseline (Day 1), Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Lead, Vision Care | Alcon Research, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Integra Eye Care | Burnaby | British Columbia | V5E 1G3 | Canada | ||
| University of Waterloo School of Optometry |
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Of the 69 subjects enrolled in the study (signed an informed consent), 1 subject was determined to be ineligible and was exited from the study prior to treatment. This reporting group includes all eligible subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 - Dry Eye Symptoms | 1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days |
| FG001 | Group 2 - CL-Related Dryness Discomfort | 1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set: All subjects exposed to at least one dose of Systane Ultra PF
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 - Dry Eye Symptoms | 1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days |
| BG001 | Group 2 - CL-Related Dryness Discomfort | 1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Full Analysis Set with data at visit | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1), Day 30 |
|
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.
All participants were monitored for serious and other ocular and nonocular AEs. All-Cause Mortality was not monitored for the ocular arms. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 - Ocular Adverse Events | 1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Naspoharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Lead, Dry Eye | Alcon Research, LLC | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 3, 2023 | Aug 6, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 29, 2023 | Aug 6, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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|
| Waterloo |
| Ontario |
| N2L 3G1 |
| Canada |
| University of Auckland | Grafton | Auckland | 1142 | New Zealand |
| Rose Optometry | Frankton | Otago | 3204 | New Zealand |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Group 1 - Dry Eye Symptoms |
1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days |
|
|
| Primary | 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. | Full Analysis Set | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1), Day 30 |
|
|
|
| 0 |
| 0 |
| 0 |
| 68 |
| 0 |
| 68 |
| EG001 | Group 1 - Nonocular Adverse Events | 1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days | 0 | 34 | 0 | 34 | 2 | 34 |
| EG002 | Group 2 - Ocular Adverse Events | 1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days | 0 | 0 | 0 | 68 | 0 | 68 |
| EG003 | Group 2 - Nonocular Adverse Events | 1-2 drops of Systane Ultra PF lubricant eye drops in each eye four times a day for 30 days | 0 | 34 | 0 | 34 | 1 | 34 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.