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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYSTANE HYDRATION | Experimental | SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days |
|
| Hyabak 0.15% | Active Comparator | Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYSTANE HYDRATION lubricant eye drops | Device | Preserved with POLYQUAD (polidronium chloride) 0.001% |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 0), Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 0), Day 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Trial Leader, Global Development Operations | Alcon, A Novartis Division | Study Director |
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Of the 114 enrolled, 15 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (99).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | SYSTANE HYDRATION | SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days |
| FG001 | Hyabak 0.15% | Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This analysis population includes all subjects who were exposed to study drug (including the run-in therapy) (Safety Analysis Set).
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| ID | Title | Description |
|---|---|---|
| BG000 | SYSTANE HYDRATION | SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days |
| BG001 | Hyabak 0.15% | Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Day 0), Day 42 |
|
Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 63 days). AEs are reported as pretreatment and treatment-emergent.
An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments from subjects and through observations by the Investigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pretreatment | All subjects who consented to participate in the study prior to the initiation of study treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intervertebral disc operation | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| WW Medical Affairs Director, GMA Ophthalmics | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Hyabak 0.15% eye drops | Device | Preservative-free |
|
|
| 0.9% saline eye drops | Drug | Preservative-free, one drop 4 times a day in each eye (run-in period) |
|
| 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. | Baseline (Day 0), Day 42 |
| 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. | Baseline (Day 0), Day 42 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Total Ocular Surface Staining (TOSS) Score | 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. | This analysis population includes all subjects who received at least 1 dose of the randomized study drug (Intent-to-Treat (ITT) Analysis Set). | Mean | Standard Deviation | units on a scale |
|
| IDEEL Treatment Score | The IDEEL (Impact of dry eye on everyday life) 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. | ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response. | Mean | Standard Deviation | units on a scale |
|
| Tear Film Break-up Time (TFBUT) | TFBUT is defined as the time elapsed from the last blink until 1 or more dry spots appeared in the precorneal tear film. | ITT Analysis Set. | Mean | Standard Deviation | seconds |
|
| Hyabak 0.15% |
Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days |
|
|
| 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. | ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Day 0), Day 42 |
|
|
|
| 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. | ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline (Day 0), Day 42 |
|
|
|
| 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. | ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response. | Posted | Least Squares Mean | Standard Error | seconds | Baseline (Day 0), Day 42 |
|
|
|
| 0 |
| 114 |
| 0 |
| 114 |
| 2 |
| 114 |
| EG001 | SYSTANE HYDRATION | All subjects treated with SYSTANE HYDRATION lubricant eye drops | 0 | 50 | 1 | 50 | 12 | 50 |
| EG002 | Hyabak 0.15% | All subjects treated with Hyabak 0.15% eye drops | 0 | 49 | 1 | 49 | 6 | 49 |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (18.0) | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.