Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the clinical effectiveness of SYSTANE® BALANCE compared to REFRESH OPTIVE® Advanced in subjects with lipid-deficient dry eye.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYSTANE BALANCE | Experimental | Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days |
|
| REFRESH OPTIVE | Active Comparator | Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propylene glycol, 0.6% eye drops | Other |
|
| |
| Lubricant eye drops |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Tear Film Break-Up Time (TFBUT) at Day 35 | TFBUT (the time required for dry spots to appear on the surface of the eye after blinking) was assessed with a fluorescein strip and measured in seconds. Using a stopwatch, the investigator measured the time from the last blink until one or more black (dry) spots appeared in the precorneal tear film. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. Only one eye (analysis eye) contributed to the analysis. | Baseline (Day 0), Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in TFBUT at Day 35 | TFBUT (the time required for dry spots to appear on the surface of the eye after blinking) was assessed with a fluorescein strip and measured in seconds. Using a stopwatch, the investigator measured the time from the last blink until one or more black (dry) spots appeared in the precorneal tear film. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. Only one eye (analysis eye) contributed to the analysis. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Project Manager, PLS | Alcon, a Novartis Company | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Of the 308 enrolled, 77 were exited as screen failures prior to randomization. This reporting group includes all randomized and treated subjects (231).
Subjects were recruited from 14 study centers located in Australia (2), Taiwan (1), Singapore (1), United Kingdom (1) and the US (9).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SYSTANE BALANCE | Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days |
| FG001 | REFRESH OPTIVE | Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This analysis population includes all subjects who were randomized to one of the study treatment arms (Randomized Set).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SYSTANE BALANCE | Propylene glycol, 0.6% eye drops, 1 drop in each eye 4 times per day for 35 days |
| BG001 | REFRESH OPTIVE | Lubricant eye drops, 1 drop in each eye 4 times per day for 35 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 | Mean Change From Baseline in Tear Film Break-Up Time (TFBUT) at Day 35 | TFBUT (the time required for dry spots to appear on the surface of the eye after blinking) was assessed with a fluorescein strip and measured in seconds. Using a stopwatch, the investigator measured the time from the last blink until one or more black (dry) spots appeared in the precorneal tear film. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. Only one eye (analysis eye) contributed to the analysis. | Per Protocol Analysis Set. At each time point, only subjects with a value at both Baseline and that time point are included. | Posted | Mean | Standard Deviation | seconds | Baseline (Day 0), Day 35 |
|
Baseline (Day 0) through study completion, an average of 35 days. Adverse Events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
This analysis population includes all subjects exposed to post-randomization study treatment (Safety Analysis Set), as treated. Two subjects were randomized to one of the study drugs but received the other instead. Specifically, one subject was randomized to REFRESH OPTIVE®, but received SYSTANE® BALANCE instead; and a different subject was randomized to SYSTANE® BALANCE, but received REFRESH OPTIVE® instead.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SYSTANE BALANCE | All subjects exposed to SYSTANE® BALANCE | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess neck | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal dystrophy | Congenital, familial and genetic disorders | MedDRA (19.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head, CDMA Vision Care | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 9, 2017 | Nov 19, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 19, 2018 | Nov 19, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019946 | Propylene Glycol |
| D009883 | Ophthalmic Solutions |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
|
|
| Baseline (Day 0), Day 35 |
| Lipid Layer Thickness (LLT) Area Under the Curve (AUC120) at Day 35 | LLT was measured using the LipiView® Ocular Surface Interferometer, an ophthalmic imaging device intended for use in adult patients to capture, archive, manipulate and store digital images of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented. Using these images, the LipiView® Interferometer measures the absolute thickness of the tear film lipid layer. | Day 35 |
| Mean Change From Baseline in Global Ocular Discomfort Visual Analog Scale (VAS) Score at Day 35 | Ocular discomfort frequency and severity (each graded on a separate 100-units scale) were assessed using a visual analog scale (VAS). Frequency score was in response to the question 'how often your eyes felt uncomfortable during the past week' ranging from 'Rarely' to 'All the time.' Severity score was in response to the question 'how uncomfortable your eyes felt during the past week' ranging from 'Very mildly uncomfortable' to 'Very severely uncomfortable.' The Global Ocular Discomfort Score, ranging from 0 to 100, was calculated for the given visit, as the square root of the product of the ocular discomfort frequency score multiplied by the ocular discomfort severity score. Improvement results in a reduction of the ocular discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort score as compared to baseline. A negative change from baseline indicates improvement. | Baseline (Day 0), Day 35 |
| Withdrawal by Subject |
|
| Other - Reason not given |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | REFRESH OPTIVE | Lubricant eye drops, 1 drop in each eye 4 times per day for 35 days |
|
|
|
| Secondary | Change From Baseline in TFBUT at Day 35 | TFBUT (the time required for dry spots to appear on the surface of the eye after blinking) was assessed with a fluorescein strip and measured in seconds. Using a stopwatch, the investigator measured the time from the last blink until one or more black (dry) spots appeared in the precorneal tear film. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. Only one eye (analysis eye) contributed to the analysis. | Full Analysis Set. At each time point, only subjects with a value at both Baseline and that time point are included. | Posted | Least Squares Mean | Standard Error | seconds | Baseline (Day 0), Day 35 |
|
|
|
|
| Secondary | Lipid Layer Thickness (LLT) Area Under the Curve (AUC120) at Day 35 | LLT was measured using the LipiView® Ocular Surface Interferometer, an ophthalmic imaging device intended for use in adult patients to capture, archive, manipulate and store digital images of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented. Using these images, the LipiView® Interferometer measures the absolute thickness of the tear film lipid layer. | Area under the curve (AUC) lipid layer thickness (LLT) was removed from formal analysis as a secondary endpoint via amendment of the standalone Statistical Analysis Plan (SAP) due to a large proportion of data that were above the limit of detection. | Posted | Day 35 |
|
|
| Secondary | Mean Change From Baseline in Global Ocular Discomfort Visual Analog Scale (VAS) Score at Day 35 | Ocular discomfort frequency and severity (each graded on a separate 100-units scale) were assessed using a visual analog scale (VAS). Frequency score was in response to the question 'how often your eyes felt uncomfortable during the past week' ranging from 'Rarely' to 'All the time.' Severity score was in response to the question 'how uncomfortable your eyes felt during the past week' ranging from 'Very mildly uncomfortable' to 'Very severely uncomfortable.' The Global Ocular Discomfort Score, ranging from 0 to 100, was calculated for the given visit, as the square root of the product of the ocular discomfort frequency score multiplied by the ocular discomfort severity score. Improvement results in a reduction of the ocular discomfort frequency or severity, or both, translating into a reduction of the resulting Global Ocular Discomfort score as compared to baseline. A negative change from baseline indicates improvement. | Full Analysis Set. At each time point, only subjects with a value at both Baseline and that time point are included. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), Day 35 |
|
|
|
|
| 117 |
| 0 |
| 117 |
| 6 |
| 117 |
| EG001 | REFRESH OPTIVE | All subjects exposed to REFRESH OPTIVE® | 0 | 114 | 1 | 114 | 13 | 114 |
| Conjunctival hyperaemia | Eye disorders | MedDRA (19.1) | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (19.1) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (19.1) | Systematic Assessment |
|
| Posterior capsule opacification | Eye disorders | MedDRA (19.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Vital dye staining cornea present | Investigations | MedDRA (19.1) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| D019999 |
| Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D054327 | Lubricants |