April 2011
Volume 52, Issue 14
ARVO Annual Meeting Abstract  |   April 2011
Evaluation of Systane Balance for Effect on Area of Ocular Protection, Tear Film Break Up Time, and Interblink Interval in a Population of Dry Eye Subjects
Author Affiliations & Notes
  • Joseph M. Griffin
    Global Scientific Market Affairs, Alcon Research Ltd, Fort Worth, Texas
  • Keith J. Lane
    ORA, Inc, Andover, Massachusetts
  • George W. Ousler, III
    ORA, Inc, Andover, Massachusetts
  • Endri Angeli
    ORA, Inc, Andover, Massachusetts
  • Stephanie Breton
    ORA, Inc, Andover, Massachusetts
  • Richard Abelson
    Statistics and Data Corporation, Tempe, Arizona
  • Mark B. Abelson
    ORA, Inc, Andover, Massachusetts
    Schepens Eye Research Institute and Harvard Medical School, Boston, Massachusetts
  • Footnotes
    Commercial Relationships  Joseph M. Griffin, Alcon Research, Ltd. (E); Keith J. Lane, ORA (E); George W. Ousler, III, ORA (E); Endri Angeli, ORA (E); Stephanie Breton, ORA (E); Richard Abelson, SDC (E); Mark B. Abelson, ORA (E)
  • Footnotes
    Support  Alcon Research, Ltd
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 3847. doi:
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      Joseph M. Griffin, Keith J. Lane, George W. Ousler, III, Endri Angeli, Stephanie Breton, Richard Abelson, Mark B. Abelson; Evaluation of Systane Balance for Effect on Area of Ocular Protection, Tear Film Break Up Time, and Interblink Interval in a Population of Dry Eye Subjects. Invest. Ophthalmol. Vis. Sci. 2011;52(14):3847.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose: : Collectively termed the OPI 2.0 System (Abelson 2010), this novel diagnostic tool provides data on tear film break up time (TFBUT), tear film break up area (TFBUA), and inter-blink interval (IBI) during a non-invasive, natural blink pattern. Systane Balance is an artificial tear designed to restore lipid layer integrity and provide enhanced tear film stability. The study evaluated the performance of Systane Balance in a population of dry eye subjects using the OPI 2.0 System.

Methods: : Thirty one adult subjects with a history of mild to moderate Dry Eye completed the study. TFBUT, IBI, and TFBUA were recorded at baseline. Following baseline, Systane Balance was instilled bilaterally. Measurements were taken again at 10 and 55 minutes after installation. Patients performed QID dosing at home for a period of 8 days, then returned to repeat OPI 2.0 assessments on Day 8. Both single and repeated dosing of Systane Balance, corneal and conjunctival staining, and ocular discomfort were analyzed and related to the OPI 2.0 results.

Results: : Baseline mean TFBUT and IBI increased from initial to follow-up visits by 86% (p=0.001) and 75% (p<0.001), respectively. At the initial visit, measurements at 10 and 55 minutes were significantly higher than baseline (TFBUT: p=0.075 and p=0.008; IBI: p=0.019 and p=0.007). TFBUA improved at the 10 minute measurement for both visits (p=0.070 and p=0.048), and for the subset of patients with >2% exposure levels at baseline, the improvement continued to the 55 minute measurement (initial visit: p=0.002; follow-up visit: p=0.015). Traditional signs and symptoms all improved following 8 days of treatment with Systane Balance (corneal staining: p=0.046; conjunctival staining: p<0.00; ocular discomfort: p<0.001).

Conclusions: : Systane Balance significantly improved TFBUT, IBI, and TFBUA as measured using the OPI 2.0 system.

Clinical Trial: : http://www.clinicaltrials.gov NCT01223040

Keywords: cornea: clinical science • visual acuity • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials 

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