SYSTANE® BALANCE Symptoms (OSDI) & Inflammatory Biomarkers

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01733732
• Collaborator: (none)
• Enrollment: 54
• Arms: 2
• Duration (Months): 7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Other: SYSTANE® BALANCE Lubricant Eye Drops; Other: SYSTANE® Gel	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Study to Evaluate the Efficacy of SYSTANE® BALANCE in Reducing Symptoms and Inflammatory Biomarker Expression of HLA-DR and Tear Film Cytokines in Dry Eye Subjects With Lipid Deficiency
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Systane Balance SYSTANE® BALANCE Lubricant Eye Drops, 1 drop in each eye 4 times a day for 30 days	Other: SYSTANE® BALANCE Lubricant Eye Drops; Other Names: SYSTANE® BALANCE
Active Comparator: Systane Gel SYSTANE® Gel, 1 drop in each eye 4 times a day for 30 days	Other: SYSTANE® Gel

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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 exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Abayomi Ogundele, PharmD, Alcon Research
• Principal Investigator: Penny A. Asbell, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01733732
• Other Study ID Numbers: A00976
• First Posted: Nov 27, 2012
• Last Update Posted: Jun 29, 2018
• Last Verified: Nov 1, 2013

• Keywords provided by Alcon Research: Dry eye; Lipid deficiency; Inflammatory markers
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Lubricant Eye Drops

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 1 study center located in the US.
Pre-assignment Detail	A total of 54 subjects were screened and randomized. This reporting group includes all randomized subjects (54).

Arm/Group Title	Systane Balance	Systane Gel
Arm/Group Description	One drop in each eye 4 times a day for 30 days	One drop in each eye 4 times a day for 30 days
Period Title: Overall Study
STARTED	27	27
COMPLETED	25	27
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Systane Balance	Systane Gel	Total
Arm/Group Description	One drop in each eye 4 times a day for 30 days	One drop in each eye 4 times a day for 30 days	Total of all reporting groups
Overall Participants	27	27	54
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.3 (14.5)	63.8 (12.8)	63.0 (13.6)
Sex: Female, Male (Count of Participants)
Female	17 63%	16 59.3%	33 61.1%
Male	10 37%	11 40.7%	21 38.9%

Outcome Measures

1. Primary Outcome

Title	Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Systane Balance	Systane Gel
Arm/Group Description	One drop in each eye 4 times a day for 30 days	One drop in each eye 4 times a day for 30 days
Measure Participants	27	27
Change from baseline at Day 14, n=25, 27	-7.85 (18.19)	-12.58 (19.05)
Change from baseline at Day 30, n=27, 27	-10.23 (21.72)	-16.74 (21.13)

2. Secondary Outcome

Title	Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Systane Balance	Systane Gel
Arm/Group Description	One drop in each eye 4 times a day for 30 days	One drop in each eye 4 times a day for 30 days
Measure Participants	27	27
Change from baseline at Day 14, n=50, 53	-0.02 (0.06)	-0.01 (0.04)
Change from baseline at Day 30, n=54, 51	-0.02 (0.06)	-0.02 (0.06)

3. Secondary Outcome

Title	Percentage of Eyes With Normal Slit-lamp Assessment
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Systane Balance, Day 0	Systane Balance, Day 14	Systane Balance, Day 30	Systane Gel, Day 0	Systane Gel, Day 14	Systane Gel, Day 30
Arm/Group Description	One drop in each eye 4 times a day for 30 days	One drop in each eye 4 times a day for 30 days	One drop in each eye 4 times a day for 30 days	One drop in each eye 4 times a day for 30 days	One drop in each eye 4 times a day for 30 days	One drop in each eye 4 times a day for 30 days
Measure Participants	27	27	27	27	27	27
Measure eyes	54	54	54	54	54	54
Orbit / Lids	0.0	0.0	0.0	0.0	0.0	0.0
Conjunctiva	92.6	96.0	96.3	96.3	100.0	100.0
Cornea	92.6	92.0	92.6	92.6	92.6	92.6
Anterior chamber	100.0	100.0	100.0	100.0	100.0	100.0
Iris	94.4	94.0	94.4	100.0	100.0	100.0
Lens	44.4	44.0	44.4	51.9	51.9	51.9

4. Secondary Outcome

Title	Meibomian Gland Expression
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Systane Balance	Systane Gel
Arm/Group Description	One drop in each eye 4 times a day for 30 days	One drop in each eye 4 times a day for 30 days
Measure Participants	27	27
Measure eyes	54	54
Baseline (Day 0), n=54, 54	1.4 (0.60)	1.6 (0.77)
Day 14, n=50, 54	1.2 (0.59)	1.3 (0.59)
Day 30, n=54, 54	1.2 (0.59)	1.3 (0.68)

5. Secondary Outcome

Title	Mean Change From Baseline in Non-invasive Keratographic Tear Break up Time (NIKBUT) by Visit
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Systane Balance	Systane Gel
Arm/Group Description	One drop in each eye 4 times a day for 30 days	One drop in each eye 4 times a day for 30 days
Measure Participants	27	27
Measure eyes	54	54
Change from baseline at Day 14, n=45, 54	0.587 (6.696)	-0.325 (4.557)
Change from baseline at Day 30, n=49, 52	-0.914 (5.697)	1.261 (6.633)

6. Secondary Outcome

Title	Mean Change From Baseline in Tear Meniscus Height (TMH) by Visit
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Systane Balance	Systane Gel
Arm/Group Description	One drop in each eye 4 times a day for 30 days	One drop in each eye 4 times a day for 30 days
Measure Participants	27	27
Measure eyes	54	54
Change from baseline at Day 14, n=50, 54	0.146 (0.165)	0.089 (0.181)
Change from baseline at Day 30, n=54, 52	0.140 (0.168)	0.165 (0.242)

7. Secondary Outcome

Title	Mean Change From Baseline in Ocular Surface Staining by Visit
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Systane Balance, Change From Baseline at Day 14	Systane Balance, Change From Baseline at Day 30	Systane Gel, Change From Baseline at Day 14	Systane Gel, Change From Baseline at Day 30
Arm/Group Description	One drop in each eye 4 times a day for 30 days	One drop in each eye 4 times a day for 30 days	One drop in each eye 4 times a day for 30 days	One drop in each eye 4 times a day for 30 days
Measure Participants	25	27	27	27
Measure eyes	50	54	54	54
Corneal staining	-1.0 (2.0)	-0.9 (2.3)	-1.3 (2.2)	-1.6 (2.4)
Conjunctival staining	-0.7 (1.4)	-0.7 (1.4)	-0.9 (1.5)	-1.0 (1.4)

8. Secondary Outcome

Title	Mean Change From Baseline in Tear Inflammatory Cytokine Expression at Day 30
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Systane Balance	Systane Gel
Arm/Group Description	One drop in each eye 4 times a day for 30 days	One drop in each eye 4 times a day for 30 days
Measure Participants	27	27
IFN-gamma, n=24, 25	2.680 (14.366)	15.146 (65.229)
IL-1beta, n=24, 25	0.192 (1.161)	0.335 (2.515)
IL-6, n=24, 25	0.902 (5.009)	0.735 (16.364)
TNF-alpha, n=24, 25	-0.058 (1.713)	0.693 (5.727)

9. Secondary Outcome

Title	Mean Change From Baseline for % HLA-DR Inflammatory Biomarker Expression at Day 30
Description	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

Outcome Measure Data

Analysis Population Description

This analysis population includes all subjects who were randomized and attended at least one post-baseline study visit.

Arm/Group Title	Systane Balance	Systane Gel
Arm/Group Description	One drop in each eye 4 times a day for 30 days	One drop in each eye 4 times a day for 30 days
Measure Participants	27	27
Measure eyes	54	54
Mean (Standard Deviation) [percentage of cells]	-0.751 (1.934)	-0.300 (0.844)

10. Secondary Outcome

Title	Mean Change From Baseline mRNA for % HLA-DR and TNF-alpha Gene Expression at Day 30
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Systane Balance	Systane Gel
Arm/Group Description	One drop in each eye 4 times a day for 30 days	One drop in each eye 4 times a day for 30 days
Measure Participants	27	27
HLA-DR, n=19, 25	0.079 (2.199)	0.019 (1.027)
TNF-alpha, n=20, 23	-0.061 (0.313)	0.009 (0.140)

11. Secondary Outcome

Title	Mean Change From Baseline in Dry Eye Status as Measured by the Schirmer's Test by Visit
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Systane Balance	Systane Gel
Arm/Group Description	One drop in each eye 4 times a day for 30 days	One drop in each eye 4 times a day for 30 days
Measure Participants	27	27
Measure eyes	54	54
Change from baseline at Day 14, n=50, 54	-0.3 (7.0)	2.8 (7.9)
Change from baseline at Day 30, n=54, 54	4.6 (8.5)	2.6 (8.2)

12. Secondary Outcome

Title	Mean Change From Baseline in Intraocular Pressure (IOP) by Visit
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Systane Balance	Systane Gel
Arm/Group Description	One drop in each eye 4 times a day for 30 days	One drop in each eye 4 times a day for 30 days
Measure Participants	27	27
Measure eyes	54	54
Change from baseline at Day 14, n=50, 54	0.0 (0.5)	0.2 (0.9)
Change from baseline at Day 30, n=54, 54	0.1 (1.4)	-0.1 (0.2)

Adverse Events

Time Frame	Adverse events (AEs) were collected for the duration of the study (7 months). This analysis group includes all subjects exposed to the test product.
Adverse Event Reporting Description	An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reports of AEs were obtained through volunteered and elicited comments from the subjects.
Arm/Group Title	Systane Balance		Systane Gel
Arm/Group Description	One drop in each eye 4 times a day for 30 days		One drop in each eye 4 times a day for 30 days
All Cause Mortality
	Systane Balance		Systane Gel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Systane Balance		Systane Gel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		1/27 (3.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis to central nervous system	0/27 (0%)		1/27 (3.7%)
Nervous system disorders
Convulsion	0/27 (0%)		1/27 (3.7%)
Other (Not Including Serious) Adverse Events
	Systane Balance		Systane Gel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/27 (0%)		0/27 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.