SYSTANE® BALANCE Symptoms (OSDI) & Inflammatory Biomarkers

• 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: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Tracking Information

• First Submitted Date: November 21, 2012
• First Posted Date: November 27, 2012
• Results First Submitted Date: October 29, 2014
• Results First Posted Date: November 4, 2014
• Last Update Posted Date: June 29, 2018
• Study Start Date: March 2013
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 31, 2014)

Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit [ Time Frame: 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.

Original Primary Outcome Measures (submitted: November 21, 2012)

Mean Change from Baseline in Ocular Surface Disease Index (OSDI) Score at Day 30 [ Time Frame: Baseline (Day 0), Day 30 ]

The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire will be administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The Baseline (Day 0) OSDI score will be subtracted from the Day 30 OSDI score and reported as change. A negative number will represent a perceived improvement in ocular health.

Current Secondary Outcome Measures (submitted: October 31, 2014)

• Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) by Visit [ Time Frame: 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.
• Percentage of Eyes With Normal Slit-lamp Assessment [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 Tear Inflammatory Cytokine Expression at Day 30 [ Time Frame: 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.
• Mean Change From Baseline for % HLA-DR Inflammatory Biomarker Expression at Day 30 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Dry Eye Syndrome

Intervention

• Other: SYSTANE® BALANCE Lubricant Eye Drops
  Other Name: SYSTANE® BALANCE
• Other: SYSTANE® Gel

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 27, 2013): 54
• Original Estimated Enrollment (submitted: November 21, 2012): 50
• Actual Study Completion Date: October 2013
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT01733732
• Other Study ID Numbers: A00976
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Alcon Research
• Study Sponsor: Alcon Research
• Collaborators: Not Provided

Investigators

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

• PRS Account: Alcon Research
• Verification Date: November 2013