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 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.
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).
Interventions
OTHERSystane Ultra PF lubricant eye drops
Commercially available preservative free 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. * Subject with contact lens-related dry eye symptoms. * 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 IDEEL SB Score - Group 1 | Baseline (Day 1), Day 30 | 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 |
| Mean Overall CLDEQ-8 Score - Group 2 | Baseline (Day 1), Day 30 | 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. |
Countries
Canada, New Zealand
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 34 |
| 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 | 34 |
| Total | 68 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Group 2 - CL-Related Dryness Discomfort | Group 1 - Dry Eye Symptoms |
|---|---|---|---|
| Age, Continuous | 38.6 years STANDARD_DEVIATION 14.71 | 35.2 years STANDARD_DEVIATION 11.05 | 41.9 years STANDARD_DEVIATION 17.15 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 26 Participants | 16 Participants | 10 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Multi-racial | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Unknown | 14 Participants | 6 Participants | 8 Participants |
| Race/Ethnicity, Customized White | 22 Participants | 8 Participants | 14 Participants |
| Region of Enrollment Canada | 39 participants | 15 participants | 24 participants |
| Region of Enrollment New Zealand | 29 participants | 19 participants | 10 participants |
| Sex: Female, Male Female | 57 Participants | 29 Participants | 28 Participants |
| Sex: Female, Male Male | 11 Participants | 5 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 34 | 0 / 0 | 0 / 34 |
| other Total, other adverse events | 0 / 68 | 2 / 34 | 0 / 68 | 1 / 34 |
| serious Total, serious adverse events | 0 / 68 | 0 / 34 | 0 / 68 | 0 / 34 |
Outcome results
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.
Time frame: Baseline (Day 1), Day 30
Population: Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 - Dry Eye Symptoms | Mean Overall CLDEQ-8 Score - Group 2 | Day 1 | 19.4 score on a scale | Standard Deviation 5.84 |
| Group 1 - Dry Eye Symptoms | Mean Overall CLDEQ-8 Score - Group 2 | Day 30 | 10.3 score on a scale | Standard Deviation 4.64 |
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
Time frame: Baseline (Day 1), Day 30
Population: Full Analysis Set with data at visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 - Dry Eye Symptoms | Mean Overall IDEEL SB Score - Group 1 | Day 1 | 45.53 score on a scale | Standard Deviation 11.784 |
| Group 1 - Dry Eye Symptoms | Mean Overall IDEEL SB Score - Group 1 | Day 30 | 31.23 score on a scale | Standard Deviation 10.854 |