April 2009
Volume 50, Issue 13
ARVO Annual Meeting Abstract  |   April 2009
Artificial Tear Use Improves Objective Signs and Visual Symptoms of Dry Eye
Author Affiliations & Notes
  • P. A. Simmons
    Ophthalmology Clinical Research,
    Allergan, Inc, Irvine, California
  • M. Gilbert
    Ophthalmology Clinical Research,
    Allergan, Inc, Irvine, California
  • F. Lai
    Allergan, Inc, Irvine, California
  • J. G. Vehige
    Ophthalmology Clinical Research,
    Allergan, Inc, Irvine, California
  • Footnotes
    Commercial Relationships  P.A. Simmons, Allergan Inc., E; M. Gilbert, Allergan Inc., E; F. Lai, Allergan Inc., E; J.G. Vehige, Allergan Inc., E.
  • Footnotes
    Support  None.
Investigative Ophthalmology & Visual Science April 2009, Vol.50, 4646. doi:
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    • Get Citation

      P. A. Simmons, M. Gilbert, F. Lai, J. G. Vehige; Artificial Tear Use Improves Objective Signs and Visual Symptoms of Dry Eye. Invest. Ophthalmol. Vis. Sci. 2009;50(13):4646.

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

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Purpose: : Artificial tears are used to improve ocular surface status, relieve ocular discomfort, and improve visual symptoms in dry eye patients. Results of a clinical trial are presented and were examined to study visual symptom response following treatment with artificial tears.

Methods: : Objective and subjective data were collected in a multicenter, randomized, controlled clinical trial in which subjects with dry eye signs and symptoms used either 0.5% Carboxymethylcellulose sodium (CMC)/0.9% Glycerin eye drops (OptiveTM Sensitive Preservative-Free Lubricant Eye Drops, Allergan) or 0.5% CMC eye drops (Refresh Plus® Lubricant Eye Drops, Allergan) at least twice a day for 30 days. Signs and symptoms including Schirmer Test, Tear Break-Up Time (TBUT), corneal and conjunctival staining, Ocular Surface Disease Index (OSDI©), plus additional subjective, acceptability, and safety variables were assessed at baseline (Day 1), Day 7, and Day 30. Visual symptoms were assessed with the vision subset of the OSDI (OSDIV) and a Visual Analog Scale (Vision VAS).

Results: : There was a statistically significant improvement (p ≤ 0.006) from baseline within each group for: OSDI©, Schirmer Test, TBUT, corneal and conjunctival staining, Symptom of Dryness, and VAS Assessments (overall global assessment, dryness severity and overall vision quality) at both follow-up visits. There was no statistically-significant difference between groups. Acceptability, Preference and Sensory questionnaires indicated that both treatments were acceptable to the majority of subjects in all aspects evaluated. Both treatment groups had a low incidence of adverse events. At Day 30, OSDIv improved from 37.6±21.5 to 22.8±20.4 and 41.6±21.6 to 25.6±22.4;Vision VAS improved from 56.8±22.4 to 65.4±20.1 and 54.2±21.6 to 66.4±19.4; and central corneal staining improved from 0.7±0.8 to 0.4±0.6 and 0.8±0.8 to 0.4±0.7 for CMC/glycerin and CMC groups, respectively. These improvements were statistically significant (p<0.001) within each group but not between groups. OSDIV and Vision VAS were highly correlated at Day 30 (Spearman Correlation Coefficient r= -0.545, p<0.001 for CMC/glycerin and r= -0.485, p<0.001 for CMC).

Conclusions: : Dry eye signs and symptoms, visual symptoms and visually relevant ocular symptoms improved from baseline within 30 days with use of CMC/glycerin or CMC artificial tears. This is consistent with previous reports that visual performance as measured by contrast sensitivity and higher order aberrations improved with the use of artificial tears. The correlation between OSDIv and Vision VAS scores support the usefulness of VAS in evaluating visual symptoms.

Clinical Trial: : www.clinicaltrials.gov NCT00514852

Keywords: cornea: tears/tear film/dry eye • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • cornea: clinical science 

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