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SYSTANE® BALANCE Symptoms (OSDI) & Inflammatory Biomarkers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01733732
First received: November 21, 2012
Last updated: October 31, 2014
Last verified: October 2014
  Purpose

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 Intervention
Dry Eye Syndrome
Other: SYSTANE® BALANCE Lubricant Eye Drops
Other: SYSTANE® Gel

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Ocular Comfort Measured as Mean Change From Baseline in OSDI Score by Visit [ Time Frame: Baseline (Day 0), Day 14, Day 30 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Day 0), Day 14, Day 30 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 54
Study Start Date: March 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: SYSTANE® BALANCE
Active Comparator: Systane Gel
SYSTANE® Gel, 1 drop in each eye 4 times a day for 30 days
Other: SYSTANE® Gel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01733732

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Abayomi Ogundele, PharmD Alcon Research
Principal Investigator: Penny A. Asbell, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01733732     History of Changes
Other Study ID Numbers: A00976
Study First Received: November 21, 2012
Results First Received: October 29, 2014
Last Updated: October 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Dry eye
Lipid deficiency
Inflammatory markers

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Eye Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on November 24, 2014