Dry Eye
Conditions
Keywords
Systane BALANCE, Dry eye, lipid deficiency, NITFBUT
Brief summary
The purpose of this study was to evaluate the ability of SYSTANE® BALANCE dosed 4 times a day for 30 days to increase non-invasive tear film break up time over baseline, compared to a saline control, in dry eye subjects with lipid deficiency.
Interventions
OTHERPropylene glycol 0.6% ocular emulsion
OTHERSodium chloride 0.9% saline solution
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
* Read, sign, and date an information consent; * Willing and able to follow instructions and maintain the appointment schedule; * Best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed at Visit 1; * Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1; * Meet protocol-specified criteria for dry eye at Visit 1; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* History or evidence of ocular or intraocular surgery or serious ocular trauma in either eye within the past six months; * Current punctal occlusion of any type (e.g., collagen plugs, silicon plugs); * History of intolerance or hypersensitivity to any component of the study medications; * History or evidence of epithelial herpes simplex keratitis (dendritic keratitis); vaccinia; active or recent varicella viral disease of the cornea and/or conjunctiva; chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye; * Use of any concomitant topical ocular medications during the study period; * Use of systemic medications that may contribute to dry eye unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1; * Ocular conditions such as conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of either drop under investigation; * Unwilling to discontinue contact lens wear during the study period. Contact lens wear must have been discontinued at least one week prior to Visit 1. * Participation in an investigational drug or device study within 30 days of entering this study; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in NITFBUT at Day 30 | Baseline (Day 0), Day 30 | NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in NITFBUT at Day 14 | Baseline (Day 0), Day 14 | NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers. |
| Mean NITFBUT by Visit | Baseline (Day 0), Day 14, Day 30 | NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A longer tear film break-up time indicates a more stable tear film, which may improve dry eye symptoms in dry eye sufferers. |
| Percent Change From Baseline in NITFBUT by Visit | Baseline (Day 0), Day 14, Day 30 | NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. The percentage of participants with a lengthening in tear film break up time relative to baseline is reported. A positive value indicates an improvement in film stability, which may improve dry eye symptoms in dry eye sufferers. |
Countries
Argentina
Participant flow
Recruitment details
Participants were recruited from 1 study center located in Argentina.
Pre-assignment details
Of the 51 enrolled, 2 participants withdrew their consent prior to receiving treatment and were exited from the study. This reporting group includes all participants who received treatment.
Participants by arm
| Arm | Count |
|---|---|
| SYSTANE® BALANCE Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days | 25 |
| LARMABAK® Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days | 24 |
| Total | 49 |
Baseline characteristics
| Characteristic | SYSTANE® BALANCE | LARMABAK® | Total |
|---|---|---|---|
| Age Continuous | 45.52 years STANDARD_DEVIATION 20.06 | 42.96 years STANDARD_DEVIATION 17.71 | 44.27 years STANDARD_DEVIATION 18.79 |
| Region of Enrollment Argentina | 25 participants | 24 participants | 49 participants |
| Sex: Female, Male Female | 18 Participants | 15 Participants | 33 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 |
Outcome results
Primary
Mean Change From Baseline in NITFBUT at Day 30
NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.
Time frame: Baseline (Day 0), Day 30
Population: Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SYSTANE® BALANCE | Mean Change From Baseline in NITFBUT at Day 30 | 2.83 seconds | Standard Deviation 0.74 |
| LARMABAK® | Mean Change From Baseline in NITFBUT at Day 30 | 0.66 seconds | Standard Deviation 0.55 |
Secondary
Mean Change From Baseline in NITFBUT at Day 14
NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A positive change value indicates an improvement in tear film stability, which may improve dry eye symptoms in dry eye sufferers.
Time frame: Baseline (Day 0), Day 14
Population: Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SYSTANE® BALANCE | Mean Change From Baseline in NITFBUT at Day 14 | 1.98 seconds | Standard Deviation 0.6 |
| LARMABAK® | Mean Change From Baseline in NITFBUT at Day 14 | 0.65 seconds | Standard Deviation 0.77 |
Secondary
Mean NITFBUT by Visit
NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. A longer tear film break-up time indicates a more stable tear film, which may improve dry eye symptoms in dry eye sufferers.
Time frame: Baseline (Day 0), Day 14, Day 30
Population: Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SYSTANE® BALANCE | Mean NITFBUT by Visit | Baseline | 4.60 seconds | Standard Deviation 0.69 |
| SYSTANE® BALANCE | Mean NITFBUT by Visit | Day 14 | 6.58 seconds | Standard Deviation 0.74 |
| SYSTANE® BALANCE | Mean NITFBUT by Visit | Day 30 | 7.43 seconds | Standard Deviation 0.51 |
| LARMABAK® | Mean NITFBUT by Visit | Baseline | 4.93 seconds | Standard Deviation 0.8 |
| LARMABAK® | Mean NITFBUT by Visit | Day 14 | 5.57 seconds | Standard Deviation 0.93 |
| LARMABAK® | Mean NITFBUT by Visit | Day 30 | 5.59 seconds | Standard Deviation 0.66 |
Secondary
Percent Change From Baseline in NITFBUT by Visit
NITFBUT is defined as the time elapsed between eye opening after a blink and the appearance of the first break in the tear film, ie, dry area. NITFBUT was evaluated noninvasively with a Tearscope. One eye from each participant was chosen as the study eye, and only data for the study eye contributed to the analysis. The percentage of participants with a lengthening in tear film break up time relative to baseline is reported. A positive value indicates an improvement in film stability, which may improve dry eye symptoms in dry eye sufferers.
Time frame: Baseline (Day 0), Day 14, Day 30
Population: Intent-to-treat: All randomized participants who received test product and attended at least one on-therapy study visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SYSTANE® BALANCE | Percent Change From Baseline in NITFBUT by Visit | Percent Change from Baseline at Day 14 | 44.99 percent change | Standard Deviation 19.46 |
| SYSTANE® BALANCE | Percent Change From Baseline in NITFBUT by Visit | Percent Change from Baseline at Day 30 | 65.03 percent change | Standard Deviation 28.41 |
| LARMABAK® | Percent Change From Baseline in NITFBUT by Visit | Percent Change from Baseline at Day 14 | 14.35 percent change | Standard Deviation 17.88 |
| LARMABAK® | Percent Change From Baseline in NITFBUT by Visit | Percent Change from Baseline at Day 30 | 15.06 percent change | Standard Deviation 14.48 |