Dry Eye Syndrome
Conditions
Keywords
Dry eye syndrome, Systane Ultra, Optive, Ocular Surface Staining, OSDI, Eye drops
Brief summary
The purpose of this study is to compare Systane® ULTRA lubricant eye drops to OPTIVE® lubricating eye drops for ocular surface staining within dry eye subjects and to evaluate the safety of Systane® ULTRA after 3 months of use.
Detailed description
Following a 2-week washout phase with saline eye drops, subjects were randomized to receive either Systane® ULTRA or OPTIVE® for the remainder of the study.
Interventions
OTHERPreservative-free saline solution eyedrops
1 drop in each eye, 4 times a day, for up to two weeks as washout prior to Phase I and Phase II.
OTHERSystane® ULTRA lubricant eyedrops
OTHEROPTIVE® lubricating eyedrops
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing and able to attend all study visits. * Diagnosis of dry eye, as specified in protocol. * Uses artificial tears, as specified in protocol. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Poor visual acuity, as specified in protocol. * Women of childbearing potential who are pregnant, lactating, or not using adequate birth control, as specified in protocol. * Any hypersensitivity or allergy to the investigational products or ingredients. * Any eye disorder, ocular surgery, medication, medical condition, or systemic disease, as specified in protocol. * Contact lens use within 2 weeks of Screening Visit. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I) | Baseline, Day 35 | The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I) | Day 35 | The OSDI is a 12-item, quality of life questionnaire that evaluates symptoms based on 3 modules (type of discomfort, environmental triggers, and tasking) on a 0-4 Likert scale (0=None of the time, 4=All of the time). A resultant overall 0-100 score was calculated, where 0=No disability and 100=Complete disability. Both eyes contributed to the analysis. |
| Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I) | Day 35 | The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment effectiveness scored on a 0-4 Likert-type scale, where 0=None of the time, 1=A little of the time, 2=Some of the time, 3=Most of the time, and 4=All of the time. The IDEEL score for treatment effectiveness was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis. |
| Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I) | Day 35 | The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment inconvenience scored on a 0-4 Likert-type scale, where 0=All of the time, 1=Most of the time, 2=Some of the time, 3=A little of the time, and 4=None of the time. The IDEEL score for treatment inconvenience was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis. |
Participant flow
Recruitment details
Subjects were recruited from 13 study centers located in France and 3 study centers located in Germany.
Pre-assignment details
Of the 105 enrolled, 11 subjects were exited prior to randomization: 9 screen failures, 1 adverse event, and 1 lost to follow-up. This reporting group includes all randomized subjects (94).
Participants by arm
| Arm | Count |
|---|---|
| Systane Ultra Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II). | 46 |
| Optive Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II). | 48 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Phase I, Day 0 to Day 35 | Adverse Event | 2 | 4 |
| Phase I, Day 0 to Day 35 | Lost to Follow-up | 1 | 0 |
| Phase I, Day 0 to Day 35 | Withdrawal by Subject | 0 | 2 |
| Phase I, Day 0 to Day 35 | Withdrawal by subject prior to treatment | 0 | 1 |
| Phase II, Day 35 to Day 90 | Adverse Event | 1 | 0 |
| Phase II, Day 35 to Day 90 | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Systane Ultra | Optive | Total |
|---|---|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 13.1 | 65.2 years STANDARD_DEVIATION 14.3 | 64.4 years STANDARD_DEVIATION 13.7 |
| Mean Total Ocular Surface Staining (TOSS) Score | 5.5 units on a scale STANDARD_DEVIATION 1.9 | 5.5 units on a scale STANDARD_DEVIATION 1.7 | 5.5 units on a scale STANDARD_DEVIATION 1.8 |
| Sex: Female, Male Female | 39 Participants | 40 Participants | 79 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 105 | 2 / 46 | 3 / 47 |
| serious Total, serious adverse events | 1 / 105 | 1 / 46 | 0 / 47 |
Outcome results
Primary
Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I)
The TOSS score is a composite score of corneal fluorescein staining, nasal conjunctival lissamine green staining, and temporal conjunctival lissamine green staining, each scored on a 0-5 Likert scale (0=absent, 5=severe). TOSS scores can range from 0 to 15. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Day 35
Population: This analysis group includes all randomized subjects with data at visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Systane Ultra | Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I) | -2.2 units on a scale | Standard Deviation 2.3 |
| Optive | Mean Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 35 (Phase I) | -1.7 units on a scale | Standard Deviation 2.4 |
Secondary
Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I)
The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment effectiveness scored on a 0-4 Likert-type scale, where 0=None of the time, 1=A little of the time, 2=Some of the time, 3=Most of the time, and 4=All of the time. The IDEEL score for treatment effectiveness was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.
Time frame: Day 35
Population: This analysis group includes all subjects with data at visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Systane Ultra | Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I) | 62.2 units on a scale | Standard Deviation 27.3 |
| Optive | Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Effectiveness Score at Day 35 (Phase I) | 55.7 units on a scale | Standard Deviation 29.4 |
Secondary
Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I)
The IDEEL is a 10-item, patient-reported questionnaire used to measure treatment satisfaction. The subject answered 4 questions pertaining to treatment inconvenience scored on a 0-4 Likert-type scale, where 0=All of the time, 1=Most of the time, 2=Some of the time, 3=A little of the time, and 4=None of the time. The IDEEL score for treatment inconvenience was calculated based upon the mean value of the 4 questions multiplied by 25, for a resultant overall score of 0-100, where 0=Complete disability and 100=No disability. Both eyes contributed to the analysis.
Time frame: Day 35
Population: This analysis group includes all subjects with data at visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Systane Ultra | Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I) | 69.5 units on a scale | Standard Deviation 15.8 |
| Optive | Mean Impact of Dry Eye on Everyday Life (IDEEL) Treatment Inconvenience Score at Day 35 (Phase I) | 67.1 units on a scale | Standard Deviation 23.6 |
Secondary
Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I)
The OSDI is a 12-item, quality of life questionnaire that evaluates symptoms based on 3 modules (type of discomfort, environmental triggers, and tasking) on a 0-4 Likert scale (0=None of the time, 4=All of the time). A resultant overall 0-100 score was calculated, where 0=No disability and 100=Complete disability. Both eyes contributed to the analysis.
Time frame: Day 35
Population: This analysis group includes all subjects with data at visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Systane Ultra | Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I) | 31.0 units on a scale | Standard Deviation 18.3 |
| Optive | Mean Ocular Surface Disease Index (OSDI) Score at Day 35 (Phase I) | 35.4 units on a scale | Standard Deviation 17.1 |