Dry Eye Syndrome
Conditions
Brief summary
The purpose of this study is to evaluate the clinical benefits of SYSTANE® ULTRA Lubricant Eye Drops using total ocular surface staining scores in subjects with dry eye administering it either as a scheduled regimen or as-needed after 28 days of treatment.
Detailed description
This study consists of a 14-day Run-in Phase (between the Screening Visit and Baseline/Visit 1) and a Treatment Phase. During the Run-in Phase, subjects will discontinue current artificial tears and will be dispensed SYSTANE® ULTRA to be administered 1 drop in each eye as needed (PRN). Subjects who meet the re-evaluation criteria after the Run-in Phase will be randomized in a 1:2 manner to receive treatment with SYSTANE® ULTRA 4 times per day (QID) or PRN, respectively, for 28 days.
Interventions
DRUGSYSTANE® ULTRA Lubricant Eye Drops
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing and able to attend all study visits. * Use of BAK-free artificial tear drops on an as needed basis, at least once a week, for at least 3 months prior to Screening Visit (maximum use of 4 drops a day). * At least one '8 hour waking period' per week during the run-in phase without using the provided artificial tear. * Use provided artificial tear at least once a week during run-in phase. * Willing to take study treatment as directed for the entire study and able to complete the study diaries as required. * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Use of artificial tears, as specified in the protocol. * Use of topical ocular medications, as specified in the protocol. * Women of childbearing potential who are pregnant, breast feeding, plan to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study. * Any hypersensitivity to the use of the study product formulations or an allergy to any ingredient(s) contained within product formulations. * Ocular abnormalities, infection, or active inflammation (not associated with dry eye) as specified in the protocol. * Ocular or intraocular surgery or serious ocular trauma in either eye within the past 6 months prior to Screening Visit. * Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study. * Contact lens use within 2 weeks prior to Screening Visit, and unwilling to avoid contact lens use during the course of the study. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28 | Baseline (Day 0), Day 28 | The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded three areas of the ocular surface for dryness on a scale from 0 to 5, where 0 is Absent and 5 is Severe. The three scores were summed for a resultant overall 0-15 score. The change from baseline was calculated as the TOSS score at Day 28 minus the TOSS score at baseline. A more negative change value indicates greater efficacy. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score at Day 28 | Baseline (Day 0), Day 28 | The IDEEL SB module is a 20 question patient reported outcome questionnaire that assesses the subject's symptoms of dry eye. An overall resultant calculated score ranges from 0 to 100, with higher scores indicating greater symptom bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses. |
| Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28 | Baseline (Day 0), Day 28 | The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use (Treatment Effectiveness and Treatment Inconvenience). A resultant overall 0-100 treatment satisfaction score was calculated separately for Treatment Effectiveness and Treatment Inconvenience, with higher scores indicating greater satisfaction and less treatment-related bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses. |
Participant flow
Recruitment details
Subjects were recruited from 6 study centers located in the US and 2 study centers located in Australia.
Pre-assignment details
Of the 159 enrolled, 58 subjects were exited as screen failures prior to randomization. An additional 4 subjects were randomized in error and did not receive investigational product (IP). This reporting group includes all treated subjects (97).
Participants by arm
| Arm | Count |
|---|---|
| Systane Ultra QID SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days | 34 |
| Systane Ultra PRN SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days | 63 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Systane Ultra PRN | Total | Systane Ultra QID |
|---|---|---|---|
| Age, Continuous | 52.2 years STANDARD_DEVIATION 18.1 | 50.4 years STANDARD_DEVIATION 17.7 | 47.2 years STANDARD_DEVIATION 16.6 |
| IDEEL Treatment Satisfaction Scores Effectiveness | 57.54 units on a scale STANDARD_DEVIATION 20.428 | 57.41 units on a scale STANDARD_DEVIATION 20.419 | 57.17 units on a scale STANDARD_DEVIATION 20.708 |
| IDEEL Treatment Satisfaction Scores Inconvenience | 84.03 units on a scale STANDARD_DEVIATION 14.189 | 84.15 units on a scale STANDARD_DEVIATION 14.52 | 84.38 units on a scale STANDARD_DEVIATION 15.329 |
| Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score | 46.75 units on a scale STANDARD_DEVIATION 9.854 | 45.50 units on a scale STANDARD_DEVIATION 10.372 | 43.20 units on a scale STANDARD_DEVIATION 11.049 |
| Sex: Female, Male Female | 51 Participants | 77 Participants | 26 Participants |
| Sex: Female, Male Male | 12 Participants | 20 Participants | 8 Participants |
| Total Ocular Surface Staining (TOSS) Score | 5.0 units on a scale STANDARD_DEVIATION 1.07 | 5.0 units on a scale STANDARD_DEVIATION 1.14 | 5.1 units on a scale STANDARD_DEVIATION 1.28 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 159 | 0 / 34 | 0 / 63 |
| other Total, other adverse events | 0 / 159 | 0 / 34 | 0 / 63 |
| serious Total, serious adverse events | 0 / 159 | 0 / 34 | 0 / 63 |
Outcome results
Primary
Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28
The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded three areas of the ocular surface for dryness on a scale from 0 to 5, where 0 is Absent and 5 is Severe. The three scores were summed for a resultant overall 0-15 score. The change from baseline was calculated as the TOSS score at Day 28 minus the TOSS score at baseline. A more negative change value indicates greater efficacy. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.
Time frame: Baseline (Day 0), Day 28
Population: Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with non-missing response.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Systane Ultra QID | Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28 | -1.19 units on a scale | Standard Error 0.26 |
| Systane Ultra PRN | Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28 | -0.94 units on a scale | Standard Error 0.24 |
Secondary
Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28
The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use (Treatment Effectiveness and Treatment Inconvenience). A resultant overall 0-100 treatment satisfaction score was calculated separately for Treatment Effectiveness and Treatment Inconvenience, with higher scores indicating greater satisfaction and less treatment-related bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.
Time frame: Baseline (Day 0), Day 28
Population: Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with non-missing response.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Systane Ultra QID | Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28 | Effectiveness | 2.43 units on a scale | Standard Error 3.53 |
| Systane Ultra QID | Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28 | Inconvenience | -11.56 units on a scale | Standard Error 2.94 |
| Systane Ultra PRN | Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28 | Effectiveness | 0.16 units on a scale | Standard Error 3.21 |
| Systane Ultra PRN | Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28 | Inconvenience | -2.77 units on a scale | Standard Error 2.67 |
Secondary
Change From Baseline in Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score at Day 28
The IDEEL SB module is a 20 question patient reported outcome questionnaire that assesses the subject's symptoms of dry eye. An overall resultant calculated score ranges from 0 to 100, with higher scores indicating greater symptom bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.
Time frame: Baseline (Day 0), Day 28
Population: Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with non-missing response.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Systane Ultra QID | Change From Baseline in Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score at Day 28 | -7.00 units on a scale | Standard Error 2.01 |
| Systane Ultra PRN | Change From Baseline in Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score at Day 28 | -2.94 units on a scale | Standard Error 1.85 |