Dry Eye
Conditions
Brief 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.
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.
Interventions
OTHERPropylene glycol solution/drops
Commercially available eye drops
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - By Dry Eye Group | 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 | 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. |
Countries
Canada
Participant flow
Recruitment details
Subjects were recruited from 4 investigative sites located in Canada.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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). | 32 |
| 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). | 22 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | As detailed in the Clinical Study Report | 0 | 2 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Aqueous Deficient Dry Eye | Total | Mixed Dry Eye | Evaporative Dry Eye |
|---|---|---|---|---|
| Age, Continuous | 49.0 years STANDARD_DEVIATION 17.62 | 51.1 years STANDARD_DEVIATION 14.43 | 55.0 years STANDARD_DEVIATION 11.99 | 49.2 years STANDARD_DEVIATION 14.34 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 22 participants | 10 participants | 11 participants |
| Race/Ethnicity, Customized Black or African American | 0 participants | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 participants | 16 participants | 3 participants | 10 participants |
| Race/Ethnicity, Customized Mixed | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 11 participants | 51 participants | 19 participants | 21 participants |
| Race/Ethnicity, Customized Other | 1 participants | 3 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Unconfirmed | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Unknown | 0 participants | 15 participants | 2 participants | 9 participants |
| Race/Ethnicity, Customized White | 8 participants | 26 participants | 9 participants | 9 participants |
| Region of Enrollment Canada | 14 participants | 68 participants | 22 participants | 32 participants |
| Sex: Female, Male Female | 12 Participants | 47 Participants | 11 Participants | 24 Participants |
| Sex: Female, Male Male | 2 Participants | 21 Participants | 11 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 28 | 0 / 14 | 0 / 64 | 0 / 32 | 0 / 44 | 0 / 22 | 0 / 136 | 0 / 68 |
| other Total, other adverse events | 0 / 68 | 0 / 28 | 0 / 14 | 0 / 64 | 0 / 32 | 0 / 44 | 0 / 22 | 0 / 136 | 0 / 68 |
| serious Total, serious adverse events | 0 / 68 | 0 / 28 | 0 / 14 | 0 / 64 | 0 / 32 | 0 / 44 | 0 / 22 | 0 / 136 | 0 / 68 |
Outcome results
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.
Time frame: Baseline (Day 1 pretreatment), Day 30
Population: Full Analysis Set: All subjects/eyes exposed to at least one dose of Systane Complete PF with data at visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aqueous Deficient Dry Eye | Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - All Subjects | Baseline (Day 1 pretreatment) | 46.08 score on a scale | Standard Deviation 12.15 |
| Aqueous Deficient Dry Eye | Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - All Subjects | Day 30 | 32.24 score on a scale | Standard Deviation 10.265 |
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.
Time frame: Baseline (Day 1 pretreatment), Day 30
Population: Full Analysis Set: All subjects/eyes exposed to at least one dose of Systane Complete PF with data at visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aqueous Deficient Dry Eye | Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - By Dry Eye Group | Baseline (Day 1 pretreatment) | 41.36 score on a scale | Standard Deviation 11.095 |
| Aqueous Deficient Dry Eye | Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - By Dry Eye Group | Day 30 | 31.26 score on a scale | Standard Deviation 9.449 |
| Evaporative Dry Eye | Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - By Dry Eye Group | Baseline (Day 1 pretreatment) | 47.08 score on a scale | Standard Deviation 12.689 |
| Evaporative Dry Eye | Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - By Dry Eye Group | Day 30 | 32.16 score on a scale | Standard Deviation 11.08 |
| Mixed Dry Eye | Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - By Dry Eye Group | Baseline (Day 1 pretreatment) | 47.63 score on a scale | Standard Deviation 11.756 |
| Mixed Dry Eye | Mean Overall Impact of Dry Eye on Everyday Life Symptom Bother (IDEEL SB) Score - By Dry Eye Group | Day 30 | 32.91 score on a scale | Standard Deviation 10.016 |