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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Systane Complete Preservative-Free | Experimental | 1-2 drops in each eye four times a day for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propylene glycol solution/drops | Other | Commercially available eye drops |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline (Day 1 pretreatment), 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 | ||
| Aggarwal and Associates Limited |
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Of the 71 enrolled, 3 participants did not meet the inclusion criteria and were exited from the study. This reporting group includes all eligible subjects (68).
Subjects were recruited from 4 investigative sites located in Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aqueous Deficient Dry Eye | 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient tear gland production. |
| FG001 | Evaporative Dry Eye | 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient oil in their tears (meibomian gland dysfunction). |
| FG002 | Mixed Dry Eye | 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient tear gland production and insufficient oil in their tears (meibomian gland dysfunction). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All eligible participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Aqueous Deficient Dry Eye | 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient tear gland production. |
| BG001 | Evaporative Dry Eye |
| Units | Counts |
|---|---|
| Participants |
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| 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 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. | Full Analysis Set: All subjects/eyes exposed to at least one dose of Systane Complete PF with data at visit | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1 pretreatment), Day 30 |
|
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.
AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. "At Risk" population for ocular AEs is included with unit of "eyes." The Other (Not Including Serious) Adverse Event table reports only the AEs that occurred above a 5% threshold in one or more reporting group. This analysis population includes all subjects/eyes exposed to at least one dose of Systane Complete PF.
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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 | Pretreatment | All subjects prior to exposure to Systane Complete PF | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Lead, CDMA Trial Management Operations | 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 | Apr 24, 2023 | Feb 21, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 29, 2023 | Feb 21, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Brampton |
| Ontario |
| L6T 0G1 |
| Canada |
| Eyes on Sheppard Clinic | North York | Ontario | M2N 3A1 | Canada |
| University of Waterloo Centre for Contact Lens Research | Waterloo | Ontario | N2L 3G1 | Canada |
| As detailed in the Clinical Study Report |
|
1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient oil in their tears (meibomian gland dysfunction).
| BG002 | Mixed Dry Eye | 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient tear gland production and insufficient oil in their tears (meibomian gland dysfunction). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
|
1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient tear gland production. |
| OG001 | Evaporative Dry Eye | 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient oil in their tears (meibomian gland dysfunction). |
| OG002 | Mixed Dry Eye | 1-2 drops of Systane Complete PF in each eye four times a day for 30 days. Participants in this group experienced dry eye symptoms due to insufficient tear gland production and insufficient oil in their tears (meibomian gland dysfunction). |
|
|
| Primary | 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. | Full Analysis Set: All subjects/eyes exposed to at least one dose of Systane Complete PF with data at visit | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1 pretreatment), Day 30 |
|
|
|
| 68 |
| 0 |
| 68 |
| 0 |
| 68 |
| EG001 | Aqueous Deficient Dry Eye - Ocular | Subgroup of subjects exposed to at least one dose of Systane Complete PF | 0 | 28 | 0 | 28 | 0 | 28 |
| EG002 | Aqueous Deficient Dry Eye - Nonocular | Subgroup of subjects exposed to at least one dose of Systane Complete PF | 0 | 14 | 0 | 14 | 0 | 14 |
| EG003 | Evaporative Dry Eye - Ocular | Subgroup of subjects exposed to at least one dose of Systane Complete PF | 0 | 64 | 0 | 64 | 0 | 64 |
| EG004 | Evaporative Dry Eye - Nonocular | Subgroup of subjects exposed to at least one dose of Systane Complete PF | 0 | 32 | 0 | 32 | 0 | 32 |
| EG005 | Mixed Dry Eye - Ocular | Subgroup of subjects exposed to at least one dose of Systane Complete PF | 0 | 44 | 0 | 44 | 0 | 44 |
| EG006 | Mixed Dry Eye - Nonocular | Subgroup of subjects exposed to at least one dose of Systane Complete PF | 0 | 22 | 0 | 22 | 0 | 22 |
| EG007 | Overall - Ocular | All subjects exposed to at least one dose of Systane Complete PF | 0 | 136 | 0 | 136 | 0 | 136 |
| EG008 | Overall - Nonocular | All subjects exposed to at least one dose of Systane Complete PF | 0 | 68 | 0 | 68 | 0 | 68 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
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