Dry Eye Syndrome
Conditions
Keywords
Dry eye, Lipid deficiency, Inflammatory markers
Brief summary
The purpose of this study is to evaluate the ability of SYSTANE® BALANCE and SYSTANE® Gel to improve comfort in subjects with dry eyes.
Interventions
OTHERSYSTANE® Gel
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
* Read, sign, and date the Informed Consent Document; * Must not have used any topical ocular drops for approximately 24 hours prior to Visit 1; * Meet the protocol-specified dry eye criteria at Screening Visit (Visit 1); * Intraocular pressure (IOP) less than or equal to 22 millimeters of mercury (mmHg) in both eyes; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* History or evidence of ocular or intraocular surgery or serious trauma in either eye within the past 6 months; * Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs); * 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; * Currently using Restasis but unwilling to discontinue its use 1 month prior to screening and for the entire 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 and that remains stable throughout the study; * Uncontrolled ocular conditions such as uveitis, glaucoma or any other ocular condition that may preclude the safe administration of either drop under investigation; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit | Baseline (Day 0), Day 14, Day 30 | The Ocular Surface Disease Index (OSDI) is a 12-question validated questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI scoring scale ranges from 0 to 100. The lower the score, the more symptomatic relief from dry eye symptoms a patient experiences. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates a perceived improvement in ocular comfort. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes With Normal Slit-lamp Assessment | Baseline (Day 0), Day 14, Day 30 | An undilated slit lamp exam was performed to examine the regions of the eye: orbit/lids, conjunctiva, cornea, anterior chamber, iris and lens. Each region was graded normal or abnormal. The percentage of eyes with normal assessments by region is reported. Each eye was assessed individually. Both eyes were included in the tabulation. |
| Meibomian Gland Expression | Baseline (Day 0), Day 14, Day 30 | Meibomian gland expression (ie, pressing on the meibomian glands to excrete oil) was performed by the investigator during undilated slit lamp examination and graded on a 4-point scale where 0=normal, clear oil expressed and 3=congealed or no material expressed. Each eye was assessed individually. Both eyes contributed to the mean. |
| Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit | Baseline (Day 0), Day 14, Day 30 | NIKBUT (time required for dry spots to appear on the surface of the eye after blinking) was measured in seconds using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean. |
| Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit | Baseline (Day 0), Day 14, Day 30 | TMH (the distance between the line of reflection along the top of the tear prism to the edge of the eyelid) was measured in millimeters using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean. |
| Mean Change From Baseline in Ocular Surface Staining by Visit | Baseline (Day 0), Day 14, Day 30 | Ocular surface staining (damage to the ocular surface) was assessed using non-toxic ophthalmic dye during slit-lamp review. Corneal and conjunctival staining were graded as per the National Eye Institute (NEI) pictorial scale. The ocular staining score ranges from 0 to 3. The lower the score, the less signs of dry eye disease a patient exhibits. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean. |
| Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit | Baseline (Day 0), Day 14, Day 30 | BCVA (with spectacles or other visual corrective devices) was determined using an ETDRS or modified EDTRS chart and measured in logMAR (logarithm of the minimum angle of resolution). Baseline-adjusted logMAR values were tabulated; a negative number change from baseline indicates better visual acuity. Each eye was assessed individually. Both eyes contributed to the mean. |
| Mean Change From Baseline for % HLA-DR Inflammatory Biomarker Expression at Day 30 | Baseline (Day 0), Day 30 | Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. The number of cells expressing the inflammatory marker HLA-DR (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as HLA-DR score at Day 30 minus HLA-DR score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean. |
| Mean Change From Baseline mRNA for % HLA-DR and TNF-alpha Gene Expression at Day 30 | Baseline (Day 0), Day 30 | Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. Total RNA was isolated. The number of cells expressing the inflammatory marker (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as score at Day 30 minus score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean. |
| Mean Change From Baseline in Dry Eye Status as Measured by the Schirmer's Test by Visit | Baseline (Day 0), Day 14, Day 30 | Dry eye status was assessed using the Schirmer's test. The investigator placed a paper strip on the eye under the lower lid for a specified time period. The length of the strip wetted by the tears was measured in millimeters. Baseline-adjusted values were tabulated; a positive number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean. |
| Mean Change From Baseline in Intraocular Pressure (IOP) by Visit | Baseline (Day 0), Day 14, Day 30 | IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline-adjusted values were tabulated. Each eye was assessed individually. Both eyes contributed to the mean. |
| Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30 | Baseline (Day 0), Day 30 | A tear sample was collected and cytokine (small proteins) levels were analyzed using a High Sensitive Human Cytokine MilliPlex kit and measured in picograms/milliliter (pg/mL). Baseline-adjusted scores were tabulated; a negative number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean. |
Participant flow
Recruitment details
Subjects were recruited from 1 study center located in the US.
Pre-assignment details
A total of 54 subjects were screened and randomized. This reporting group includes all randomized subjects (54).
Participants by arm
| Arm | Count |
|---|---|
| Systane Balance One drop in each eye 4 times a day for 30 days | 27 |
| Systane Gel One drop in each eye 4 times a day for 30 days | 27 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Did not attend all study visits | 1 | 0 |
Baseline characteristics
| Characteristic | Systane Balance | Systane Gel | Total |
|---|---|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 14.5 | 63.8 years STANDARD_DEVIATION 12.8 | 63.0 years STANDARD_DEVIATION 13.6 |
| Sex: Female, Male Female | 17 Participants | 16 Participants | 33 Participants |
| Sex: Female, Male Male | 10 Participants | 11 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 | 1 / 27 |
Outcome results
Primary
Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit
The Ocular Surface Disease Index (OSDI) is a 12-question validated questionnaire used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision. The OSDI scoring scale ranges from 0 to 100. The lower the score, the more symptomatic relief from dry eye symptoms a patient experiences. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates a perceived improvement in ocular comfort.
Time frame: Baseline (Day 0), Day 14, Day 30
Population: This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Systane Balance | Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit | Change from baseline at Day 14, n=25, 27 | -7.85 units on a scale | Standard Deviation 18.19 |
| Systane Balance | Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit | Change from baseline at Day 30, n=27, 27 | -10.23 units on a scale | Standard Deviation 21.72 |
| Systane Gel | Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit | Change from baseline at Day 14, n=25, 27 | -12.58 units on a scale | Standard Deviation 19.05 |
| Systane Gel | Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit | Change from baseline at Day 30, n=27, 27 | -16.74 units on a scale | Standard Deviation 21.13 |
Secondary
Mean Change From Baseline for % HLA-DR Inflammatory Biomarker Expression at Day 30
Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. The number of cells expressing the inflammatory marker HLA-DR (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as HLA-DR score at Day 30 minus HLA-DR score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean.
Time frame: Baseline (Day 0), Day 30
Population: This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Systane Balance | Mean Change From Baseline for % HLA-DR Inflammatory Biomarker Expression at Day 30 | -0.751 percentage of cells | Standard Deviation 1.934 |
| Systane Gel | Mean Change From Baseline for % HLA-DR Inflammatory Biomarker Expression at Day 30 | -0.300 percentage of cells | Standard Deviation 0.844 |
Secondary
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit
BCVA (with spectacles or other visual corrective devices) was determined using an ETDRS or modified EDTRS chart and measured in logMAR (logarithm of the minimum angle of resolution). Baseline-adjusted logMAR values were tabulated; a negative number change from baseline indicates better visual acuity. Each eye was assessed individually. Both eyes contributed to the mean.
Time frame: Baseline (Day 0), Day 14, Day 30
Population: This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Systane Balance | Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit | Change from baseline at Day 14, n=50, 53 | -0.02 LogMAR | Standard Deviation 0.06 |
| Systane Balance | Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit | Change from baseline at Day 30, n=54, 51 | -0.02 LogMAR | Standard Deviation 0.06 |
| Systane Gel | Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit | Change from baseline at Day 14, n=50, 53 | -0.01 LogMAR | Standard Deviation 0.04 |
| Systane Gel | Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit | Change from baseline at Day 30, n=54, 51 | -0.02 LogMAR | Standard Deviation 0.06 |
Secondary
Mean Change From Baseline in Dry Eye Status as Measured by the Schirmer's Test by Visit
Dry eye status was assessed using the Schirmer's test. The investigator placed a paper strip on the eye under the lower lid for a specified time period. The length of the strip wetted by the tears was measured in millimeters. Baseline-adjusted values were tabulated; a positive number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean.
Time frame: Baseline (Day 0), Day 14, Day 30
Population: This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Systane Balance | Mean Change From Baseline in Dry Eye Status as Measured by the Schirmer's Test by Visit | Change from baseline at Day 14, n=50, 54 | -0.3 millimeters | Standard Deviation 7 |
| Systane Balance | Mean Change From Baseline in Dry Eye Status as Measured by the Schirmer's Test by Visit | Change from baseline at Day 30, n=54, 54 | 4.6 millimeters | Standard Deviation 8.5 |
| Systane Gel | Mean Change From Baseline in Dry Eye Status as Measured by the Schirmer's Test by Visit | Change from baseline at Day 14, n=50, 54 | 2.8 millimeters | Standard Deviation 7.9 |
| Systane Gel | Mean Change From Baseline in Dry Eye Status as Measured by the Schirmer's Test by Visit | Change from baseline at Day 30, n=54, 54 | 2.6 millimeters | Standard Deviation 8.2 |
Secondary
Mean Change From Baseline in Intraocular Pressure (IOP) by Visit
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline-adjusted values were tabulated. Each eye was assessed individually. Both eyes contributed to the mean.
Time frame: Baseline (Day 0), Day 14, Day 30
Population: This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Systane Balance | Mean Change From Baseline in Intraocular Pressure (IOP) by Visit | Change from baseline at Day 14, n=50, 54 | 0.0 mmHg | Standard Deviation 0.5 |
| Systane Balance | Mean Change From Baseline in Intraocular Pressure (IOP) by Visit | Change from baseline at Day 30, n=54, 54 | 0.1 mmHg | Standard Deviation 1.4 |
| Systane Gel | Mean Change From Baseline in Intraocular Pressure (IOP) by Visit | Change from baseline at Day 14, n=50, 54 | 0.2 mmHg | Standard Deviation 0.9 |
| Systane Gel | Mean Change From Baseline in Intraocular Pressure (IOP) by Visit | Change from baseline at Day 30, n=54, 54 | -0.1 mmHg | Standard Deviation 0.2 |
Secondary
Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit
NIKBUT (time required for dry spots to appear on the surface of the eye after blinking) was measured in seconds using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.
Time frame: Baseline (Day 0), Day 14, Day 30
Population: This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Systane Balance | Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit | Change from baseline at Day 14, n=45, 54 | 0.587 seconds | Standard Deviation 6.696 |
| Systane Balance | Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit | Change from baseline at Day 30, n=49, 52 | -0.914 seconds | Standard Deviation 5.697 |
| Systane Gel | Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit | Change from baseline at Day 14, n=45, 54 | -0.325 seconds | Standard Deviation 4.557 |
| Systane Gel | Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit | Change from baseline at Day 30, n=49, 52 | 1.261 seconds | Standard Deviation 6.633 |
Secondary
Mean Change From Baseline in Ocular Surface Staining by Visit
Ocular surface staining (damage to the ocular surface) was assessed using non-toxic ophthalmic dye during slit-lamp review. Corneal and conjunctival staining were graded as per the National Eye Institute (NEI) pictorial scale. The ocular staining score ranges from 0 to 3. The lower the score, the less signs of dry eye disease a patient exhibits. Baseline-adjusted scores were tabulated; a negative number change from baseline indicates an improvement. Each eye was assessed individually. Both eyes contributed to the mean.
Time frame: Baseline (Day 0), Day 14, Day 30
Population: This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Systane Balance | Mean Change From Baseline in Ocular Surface Staining by Visit | Corneal staining | -1.0 units on a scale | Standard Deviation 2 |
| Systane Balance | Mean Change From Baseline in Ocular Surface Staining by Visit | Conjunctival staining | -0.7 units on a scale | Standard Deviation 1.4 |
| Systane Gel | Mean Change From Baseline in Ocular Surface Staining by Visit | Conjunctival staining | -0.7 units on a scale | Standard Deviation 1.4 |
| Systane Gel | Mean Change From Baseline in Ocular Surface Staining by Visit | Corneal staining | -0.9 units on a scale | Standard Deviation 2.3 |
| Systane Balance, Day 30 | Mean Change From Baseline in Ocular Surface Staining by Visit | Corneal staining | -1.3 units on a scale | Standard Deviation 2.2 |
| Systane Balance, Day 30 | Mean Change From Baseline in Ocular Surface Staining by Visit | Conjunctival staining | -0.9 units on a scale | Standard Deviation 1.5 |
| Systane Gel, Day 0 | Mean Change From Baseline in Ocular Surface Staining by Visit | Corneal staining | -1.6 units on a scale | Standard Deviation 2.4 |
| Systane Gel, Day 0 | Mean Change From Baseline in Ocular Surface Staining by Visit | Conjunctival staining | -1.0 units on a scale | Standard Deviation 1.4 |
Secondary
Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30
A tear sample was collected and cytokine (small proteins) levels were analyzed using a High Sensitive Human Cytokine MilliPlex kit and measured in picograms/milliliter (pg/mL). Baseline-adjusted scores were tabulated; a negative number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.
Time frame: Baseline (Day 0), Day 30
Population: This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Systane Balance | Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30 | IL-6, n=24, 25 | 0.902 pg/mL | Standard Deviation 5.009 |
| Systane Balance | Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30 | IFN-gamma, n=24, 25 | 2.680 pg/mL | Standard Deviation 14.366 |
| Systane Balance | Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30 | TNF-alpha, n=24, 25 | -0.058 pg/mL | Standard Deviation 1.713 |
| Systane Balance | Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30 | IL-1beta, n=24, 25 | 0.192 pg/mL | Standard Deviation 1.161 |
| Systane Gel | Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30 | TNF-alpha, n=24, 25 | 0.693 pg/mL | Standard Deviation 5.727 |
| Systane Gel | Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30 | IFN-gamma, n=24, 25 | 15.146 pg/mL | Standard Deviation 65.229 |
| Systane Gel | Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30 | IL-6, n=24, 25 | 0.735 pg/mL | Standard Deviation 16.364 |
| Systane Gel | Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30 | IL-1beta, n=24, 25 | 0.335 pg/mL | Standard Deviation 2.515 |
Secondary
Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit
TMH (the distance between the line of reflection along the top of the tear prism to the edge of the eyelid) was measured in millimeters using the Oculus keratograph 5M. Baseline-adjusted scores were tabulated; a positive number change from baseline indicates improvement. Each eye was assessed individually. Both eyes contributed to the mean.
Time frame: Baseline (Day 0), Day 14, Day 30
Population: This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Systane Balance | Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit | Change from baseline at Day 14, n=50, 54 | 0.146 millimeters | Standard Deviation 0.165 |
| Systane Balance | Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit | Change from baseline at Day 30, n=54, 52 | 0.140 millimeters | Standard Deviation 0.168 |
| Systane Gel | Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit | Change from baseline at Day 14, n=50, 54 | 0.089 millimeters | Standard Deviation 0.181 |
| Systane Gel | Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit | Change from baseline at Day 30, n=54, 52 | 0.165 millimeters | Standard Deviation 0.242 |
Secondary
Mean Change From Baseline mRNA for % HLA-DR and TNF-alpha Gene Expression at Day 30
Conjunctival samples were collected by Impression Cytology (IC) and analyzed in a lab. Total RNA was isolated. The number of cells expressing the inflammatory marker (as a percentage of total cells) was calculated. Baseline-adjusted scores were calculated as score at Day 30 minus score at baseline. A negative baseline-adjusted value indicates an improvement. Each eye was assessed individually. Both eyes were included in the mean.
Time frame: Baseline (Day 0), Day 30
Population: This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of subjects with non-missing values at the specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Systane Balance | Mean Change From Baseline mRNA for % HLA-DR and TNF-alpha Gene Expression at Day 30 | HLA-DR, n=19, 25 | 0.079 percentage of cells | Standard Deviation 2.199 |
| Systane Balance | Mean Change From Baseline mRNA for % HLA-DR and TNF-alpha Gene Expression at Day 30 | TNF-alpha, n=20, 23 | -0.061 percentage of cells | Standard Deviation 0.313 |
| Systane Gel | Mean Change From Baseline mRNA for % HLA-DR and TNF-alpha Gene Expression at Day 30 | HLA-DR, n=19, 25 | 0.019 percentage of cells | Standard Deviation 1.027 |
| Systane Gel | Mean Change From Baseline mRNA for % HLA-DR and TNF-alpha Gene Expression at Day 30 | TNF-alpha, n=20, 23 | 0.009 percentage of cells | Standard Deviation 0.14 |
Secondary
Meibomian Gland Expression
Meibomian gland expression (ie, pressing on the meibomian glands to excrete oil) was performed by the investigator during undilated slit lamp examination and graded on a 4-point scale where 0=normal, clear oil expressed and 3=congealed or no material expressed. Each eye was assessed individually. Both eyes contributed to the mean.
Time frame: Baseline (Day 0), Day 14, Day 30
Population: This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. Here, n is the number of eyes with non-missing values at the specific time point for each arm group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Systane Balance | Meibomian Gland Expression | Baseline (Day 0), n=54, 54 | 1.4 units on a scale | Standard Deviation 0.6 |
| Systane Balance | Meibomian Gland Expression | Day 14, n=50, 54 | 1.2 units on a scale | Standard Deviation 0.59 |
| Systane Balance | Meibomian Gland Expression | Day 30, n=54, 54 | 1.2 units on a scale | Standard Deviation 0.59 |
| Systane Gel | Meibomian Gland Expression | Baseline (Day 0), n=54, 54 | 1.6 units on a scale | Standard Deviation 0.77 |
| Systane Gel | Meibomian Gland Expression | Day 14, n=50, 54 | 1.3 units on a scale | Standard Deviation 0.59 |
| Systane Gel | Meibomian Gland Expression | Day 30, n=54, 54 | 1.3 units on a scale | Standard Deviation 0.68 |
Secondary
Percentage of Eyes With Normal Slit-lamp Assessment
An undilated slit lamp exam was performed to examine the regions of the eye: orbit/lids, conjunctiva, cornea, anterior chamber, iris and lens. Each region was graded normal or abnormal. The percentage of eyes with normal assessments by region is reported. Each eye was assessed individually. Both eyes were included in the tabulation.
Time frame: Baseline (Day 0), Day 14, Day 30
Population: This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit. The actual sample size used in calculating the outcome measure may be smaller due to missing responses and/or visit attendance.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Systane Balance | Percentage of Eyes With Normal Slit-lamp Assessment | Orbit / Lids | 0.0 percentage of eyes |
| Systane Balance | Percentage of Eyes With Normal Slit-lamp Assessment | Conjunctiva | 92.6 percentage of eyes |
| Systane Balance | Percentage of Eyes With Normal Slit-lamp Assessment | Cornea | 92.6 percentage of eyes |
| Systane Balance | Percentage of Eyes With Normal Slit-lamp Assessment | Anterior chamber | 100.0 percentage of eyes |
| Systane Balance | Percentage of Eyes With Normal Slit-lamp Assessment | Iris | 94.4 percentage of eyes |
| Systane Balance | Percentage of Eyes With Normal Slit-lamp Assessment | Lens | 44.4 percentage of eyes |
| Systane Gel | Percentage of Eyes With Normal Slit-lamp Assessment | Conjunctiva | 96.0 percentage of eyes |
| Systane Gel | Percentage of Eyes With Normal Slit-lamp Assessment | Anterior chamber | 100.0 percentage of eyes |
| Systane Gel | Percentage of Eyes With Normal Slit-lamp Assessment | Lens | 44.0 percentage of eyes |
| Systane Gel | Percentage of Eyes With Normal Slit-lamp Assessment | Orbit / Lids | 0.0 percentage of eyes |
| Systane Gel | Percentage of Eyes With Normal Slit-lamp Assessment | Cornea | 92.0 percentage of eyes |
| Systane Gel | Percentage of Eyes With Normal Slit-lamp Assessment | Iris | 94.0 percentage of eyes |
| Systane Balance, Day 30 | Percentage of Eyes With Normal Slit-lamp Assessment | Lens | 44.4 percentage of eyes |
| Systane Balance, Day 30 | Percentage of Eyes With Normal Slit-lamp Assessment | Iris | 94.4 percentage of eyes |
| Systane Balance, Day 30 | Percentage of Eyes With Normal Slit-lamp Assessment | Anterior chamber | 100.0 percentage of eyes |
| Systane Balance, Day 30 | Percentage of Eyes With Normal Slit-lamp Assessment | Cornea | 92.6 percentage of eyes |
| Systane Balance, Day 30 | Percentage of Eyes With Normal Slit-lamp Assessment | Orbit / Lids | 0.0 percentage of eyes |
| Systane Balance, Day 30 | Percentage of Eyes With Normal Slit-lamp Assessment | Conjunctiva | 96.3 percentage of eyes |
| Systane Gel, Day 0 | Percentage of Eyes With Normal Slit-lamp Assessment | Anterior chamber | 100.0 percentage of eyes |
| Systane Gel, Day 0 | Percentage of Eyes With Normal Slit-lamp Assessment | Conjunctiva | 96.3 percentage of eyes |
| Systane Gel, Day 0 | Percentage of Eyes With Normal Slit-lamp Assessment | Cornea | 92.6 percentage of eyes |
| Systane Gel, Day 0 | Percentage of Eyes With Normal Slit-lamp Assessment | Lens | 51.9 percentage of eyes |
| Systane Gel, Day 0 | Percentage of Eyes With Normal Slit-lamp Assessment | Iris | 100.0 percentage of eyes |
| Systane Gel, Day 0 | Percentage of Eyes With Normal Slit-lamp Assessment | Orbit / Lids | 0.0 percentage of eyes |
| Systane Gel, Day 14 | Percentage of Eyes With Normal Slit-lamp Assessment | Orbit / Lids | 0.0 percentage of eyes |
| Systane Gel, Day 14 | Percentage of Eyes With Normal Slit-lamp Assessment | Iris | 100.0 percentage of eyes |
| Systane Gel, Day 14 | Percentage of Eyes With Normal Slit-lamp Assessment | Conjunctiva | 100.0 percentage of eyes |
| Systane Gel, Day 14 | Percentage of Eyes With Normal Slit-lamp Assessment | Cornea | 92.6 percentage of eyes |
| Systane Gel, Day 14 | Percentage of Eyes With Normal Slit-lamp Assessment | Anterior chamber | 100.0 percentage of eyes |
| Systane Gel, Day 14 | Percentage of Eyes With Normal Slit-lamp Assessment | Lens | 51.9 percentage of eyes |
| Systane Gel, Day 30 | Percentage of Eyes With Normal Slit-lamp Assessment | Anterior chamber | 100.0 percentage of eyes |
| Systane Gel, Day 30 | Percentage of Eyes With Normal Slit-lamp Assessment | Cornea | 92.6 percentage of eyes |
| Systane Gel, Day 30 | Percentage of Eyes With Normal Slit-lamp Assessment | Iris | 100.0 percentage of eyes |
| Systane Gel, Day 30 | Percentage of Eyes With Normal Slit-lamp Assessment | Lens | 51.9 percentage of eyes |
| Systane Gel, Day 30 | Percentage of Eyes With Normal Slit-lamp Assessment | Conjunctiva | 100.0 percentage of eyes |
| Systane Gel, Day 30 | Percentage of Eyes With Normal Slit-lamp Assessment | Orbit / Lids | 0.0 percentage of eyes |