Dry Eye
Conditions
Brief summary
The purpose of this study is to compare SYSTANE® HYDRATION to Hyabak 0.15% based on total ocular surface staining scores (TOSS) at Day 42.
Detailed description
Subjects will first be dispensed preservative-free 0.9% saline eye drops (saline eye drops) to be used during the Run-in phase between Screening Visit and Day 0 (Visit 1). Subjects who qualify will be randomized in a 1:1 manner to receive either treatment with SYSTANE® HYDRATION Lubricant Eye Drops or Hyabak 0.15% Eye Drops.
Interventions
Preserved with POLYQUAD (polidronium chloride) 0.001%
DEVICEHyabak 0.15% eye drops
Preservative-free
DRUG0.9% saline eye drops
Preservative-free, one drop 4 times a day in each eye (run-in period)
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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 non-BAK (Benzalkonium Chloride) artificial tears at least once a day, for at least 3 months prior to Screening Visit; * Diagnosis of Dry Eye (by a health care professional) for at least 3 months prior to Screening Visit; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Women of childbearing potential who are pregnant or breast feeding; * Any hypersensitivity to the use of the study products or an allergy to any ingredient(s) contained within study products; * Ocular abnormalities in either eye that could adversely affect the safety or efficacy outcome; * Active ocular infection (bacterial, viral, or fungal) or active inflammation not associated with dry eye; * Use of chronic systemic medications: (prescription, over the counter, vitamins/supplements) on a stable dose for less than 30 days prior to Screening Visit, or any anticipated change in dosing regimen during the course of the study; * History of ocular or intraocular surgery or serious ocular trauma in either eye within 6 months prior to Screening Visit; * Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of study products or safe participation in the study; * Use of any topical ocular over-the-counter or prescribed medications in either eye (with the exception of artificial tears/gels/ lubricants) 2 weeks prior to Screening Visit; * Contact lens use within 2 weeks prior to Screening Visit and unwilling to avoid contact lens use during the course of the study; * Unwilling to avoid the use of additional artificial tears (other than the study products) throughout the study; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42 | Baseline (Day 0), Day 42 | The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded 3 areas of the ocular surface for dryness on a scale from 0 to 5, where 0=Absent and 5=Severe. The 3 scores were summed for a resultant overall 0-15 score. A more negative change value indicates greater efficacy. One eye (study eye) contributed to the analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42 | Baseline (Day 0), Day 42 | The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 satisfaction score was calculated, with a higher score indicating greater satisfaction and less treatment-related bother. |
| Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42 | Baseline (Day 0), Day 42 | The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 satisfaction score was calculated, with a higher score indicating greater satisfaction and less treatment-related bother. |
| Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42 | Baseline (Day 0), Day 42 | TFBUT is defined as the time elapsed from the last blink until 1 or more dry spots appeared in the precorneal tear film. A longer tear film break-up time indicates a more stable tear film and may lead to improvement in dry eye symptoms. One eye (study eye) contributed to the analysis. |
Participant flow
Recruitment details
Subjects were recruited from 3 study centers located in Germany, 3 study centers located in France, 2 study centers located in the UK, and 2 study centers located in Spain.
Pre-assignment details
Of the 114 enrolled, 15 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (99).
Participants by arm
| Arm | Count |
|---|---|
| SYSTANE HYDRATION SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days | 50 |
| Hyabak 0.15% Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days | 49 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | SYSTANE HYDRATION | Hyabak 0.15% | Total |
|---|---|---|---|
| Age, Continuous | 61.7 years STANDARD_DEVIATION 12.29 | 56.7 years STANDARD_DEVIATION 14.29 | 59.2 years STANDARD_DEVIATION 13.49 |
| IDEEL Treatment Score Treatment Effectiveness | 52.04 units on a scale STANDARD_DEVIATION 29.602 | 51.56 units on a scale STANDARD_DEVIATION 28.641 | 51.80 units on a scale STANDARD_DEVIATION 28.979 |
| IDEEL Treatment Score Treatment Inconvenience | 83.42 units on a scale STANDARD_DEVIATION 17.749 | 81.90 units on a scale STANDARD_DEVIATION 17.829 | 82.67 units on a scale STANDARD_DEVIATION 17.712 |
| Sex: Female, Male Female | 41 Participants | 38 Participants | 79 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 20 Participants |
| Tear Film Break-up Time (TFBUT) | 3.20 seconds STANDARD_DEVIATION 2.01 | 3.58 seconds STANDARD_DEVIATION 2.222 | 3.39 seconds STANDARD_DEVIATION 2.115 |
| Total Ocular Surface Staining (TOSS) Score | 5.26 units on a scale STANDARD_DEVIATION 1.411 | 4.98 units on a scale STANDARD_DEVIATION 1.09 | 5.12 units on a scale STANDARD_DEVIATION 1.264 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 114 | 0 / 50 | 0 / 49 |
| other Total, other adverse events | 2 / 114 | 12 / 50 | 6 / 49 |
| serious Total, serious adverse events | 0 / 114 | 1 / 50 | 1 / 49 |
Outcome results
Primary
Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42
The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded 3 areas of the ocular surface for dryness on a scale from 0 to 5, where 0=Absent and 5=Severe. The 3 scores were summed for a resultant overall 0-15 score. A more negative change value indicates greater efficacy. One eye (study eye) contributed to the analysis.
Time frame: Baseline (Day 0), Day 42
Population: ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SYSTANE HYDRATION | Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42 | -1.16 units on a scale | Standard Error 0.24 |
| Hyabak 0.15% | Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42 | -0.92 units on a scale | Standard Error 0.23 |
Secondary
Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42
The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 satisfaction score was calculated, with a higher score indicating greater satisfaction and less treatment-related bother.
Time frame: Baseline (Day 0), Day 42
Population: ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SYSTANE HYDRATION | Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42 | 9.62 units on a scale | Standard Error 3.19 |
| Hyabak 0.15% | Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42 | 12.80 units on a scale | Standard Error 3.17 |
Secondary
Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42
The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 satisfaction score was calculated, with a higher score indicating greater satisfaction and less treatment-related bother.
Time frame: Baseline (Day 0), Day 42
Population: ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SYSTANE HYDRATION | Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42 | -10.32 units on a scale | Standard Error 2.22 |
| Hyabak 0.15% | Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42 | 2.24 units on a scale | Standard Error 2.22 |
Secondary
Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42
TFBUT is defined as the time elapsed from the last blink until 1 or more dry spots appeared in the precorneal tear film. A longer tear film break-up time indicates a more stable tear film and may lead to improvement in dry eye symptoms. One eye (study eye) contributed to the analysis.
Time frame: Baseline (Day 0), Day 42
Population: ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SYSTANE HYDRATION | Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42 | 0.39 seconds | Standard Error 0.38 |
| Hyabak 0.15% | Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42 | 0.68 seconds | Standard Error 0.37 |