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SYSTANE® BALANCE Symptoms (OSDI) & Inflammatory Biomarkers

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ClinicalTrials.gov Identifier: NCT01733732
Recruitment Status : Completed
First Posted : November 27, 2012
Results First Posted : November 4, 2014
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dry Eye Syndrome
Interventions Other: SYSTANE® BALANCE Lubricant Eye Drops
Other: SYSTANE® Gel
Enrollment 54
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).
Arm/Group Title Systane Balance Systane Gel
Hide 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
Reason Not Completed
Adverse Event             1             0
Did not attend all study visits             1             0
Arm/Group Title Systane Balance Systane Gel Total
Hide 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 Number of Baseline Participants 27 27 54
Hide Baseline Analysis Population Description
This analysis group includes all randomized subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 27 participants 54 participants
62.3  (14.5) 63.8  (12.8) 63.0  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 participants
Female
17
  63.0%
16
  59.3%
33
  61.1%
Male
10
  37.0%
11
  40.7%
21
  38.9%
1.Primary Outcome
Title Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 27 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 27 27
Mean (Standard Deviation)
Unit of Measure: LogMAR
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 27 27 27 27 27 27
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
54 54 54 54 54 54
Measure Type: Number
Unit of Measure: percentage of eyes
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 27 27
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
54 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 27 27
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
54 54
Mean (Standard Deviation)
Unit of Measure: seconds
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 27 27
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
54 54
Mean (Standard Deviation)
Unit of Measure: millimeters
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 25 27 27 27
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
50 54 54 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 27 27
Mean (Standard Deviation)
Unit of Measure: pg/mL
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 27 27
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
54 54
Mean (Standard Deviation)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 27 27
Mean (Standard Deviation)
Unit of Measure: percentage of cells
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 27 27
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
54 54
Mean (Standard Deviation)
Unit of Measure: millimeters
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 27 27
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
54 54
Mean (Standard Deviation)
Unit of Measure: mmHg
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)
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
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Systane Balance Systane Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   1/27 (3.70%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastasis to central nervous system * 1  0/27 (0.00%)  1/27 (3.70%) 
Nervous system disorders     
Convulsion  1  0/27 (0.00%)  1/27 (3.70%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Systane Balance Systane Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/27 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Abayomi Ogundele, Pharm.D, Global Brand Medical Affairs Lead
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01733732    
Other Study ID Numbers: A00976
First Submitted: November 21, 2012
First Posted: November 27, 2012
Results First Submitted: October 29, 2014
Results First Posted: November 4, 2014
Last Update Posted: June 29, 2018