Back to resultsSYSTANE® BALANCE Symptoms (OSDI) & Inflammatory Biomarkers
Primary Purpose
Dry Eye Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SYSTANE® BALANCE Lubricant Eye Drops
SYSTANE® Gel
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry eye, Lipid deficiency, Inflammatory markers
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Systane Balance
Systane Gel
Arm Description
SYSTANE® BALANCE Lubricant Eye Drops, 1 drop in each eye 4 times a day for 30 days
SYSTANE® Gel, 1 drop in each eye 4 times a day for 30 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01733732
Brief Title
SYSTANE® BALANCE Symptoms (OSDI) & Inflammatory Biomarkers
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 Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
Dry eye, Lipid deficiency, Inflammatory markers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Systane Balance
Arm Type
Experimental
Arm Description
SYSTANE® BALANCE Lubricant Eye Drops, 1 drop in each eye 4 times a day for 30 days
Arm Title
Systane Gel
Arm Type
Active Comparator
Arm Description
SYSTANE® Gel, 1 drop in each eye 4 times a day for 30 days
Intervention Type
Other
Intervention Name(s)
SYSTANE® BALANCE Lubricant Eye Drops
Other Intervention Name(s)
SYSTANE® BALANCE
Intervention Type
Other
Intervention Name(s)
SYSTANE® Gel
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
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
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
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
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
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abayomi Ogundele, PharmD
Organizational Affiliation
Alcon Research
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Penny A. Asbell, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
SYSTANE® BALANCE Symptoms (OSDI) & Inflammatory Biomarkers
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