June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Fixed versus pro-re-nata dosing of polyethylene glycol/propylene glycol-based artificial tears: A randomized clinical trial
Author Affiliations & Notes
  • Penny A Asbell
    Ophthalmology, Icahn School of Medicine at Mount Sinai, New York, New York, United States
  • Algis J Vingrys
    University of Melbourne, Parkville, Parkville, Victoria, Australia
  • Jacqueline Tan
    University of New South Wales, Sydney, New South Wales, Australia
  • Philip Lee Shettle
    Shettle Eye Research, Largo, Florida, United States
  • Eugene B McLaurin
    Total Eye Care, Memphis, Tennessee, United States
  • Abayomi Ogundele
    Novartis Pharmaceutical Corporation, East Hanover, New Jersey, United States
  • Laura Elizabeth Downie
    University of Melbourne, Parkville, Parkville, Victoria, Australia
  • Gary Jenkins
    Nashville Vision Associates, Nashville, Tennessee, United States
  • Footnotes
    Commercial Relationships   Penny Asbell, Alcon (C), Alcon (F), Allergan (C), Bausch and Lomb (C), MC2Biotek (F), Regeneron (C), Senju (C), Shire (C); Algis Vingrys, Alcon (F), Allergan (F); Jacqueline Tan, Alcon (F), Allergan (F), CooperVision (F); Philip Shettle, None; Eugene McLaurin, Aciex (F), Acucela (F), Aerie Pharmaceutical (F), Alcon (F), Astra Zeneca (F), Bausch &Lomb (F), For SightVision (F), Inotek Pharma (F), InSite Vision (F), Mimetoge (F), Ocular Therapeutics (F), ReGenTree (F), Xigen (F); Abayomi Ogundele, Novartis Pharmaceutical Corporation (E); Laura Downie, Alcon (F), Allergan (F), CooperVision (F); Gary Jenkins, Alcon (F), Allergan (F)
  • Footnotes
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Investigative Ophthalmology & Visual Science June 2017, Vol.58, 2685. doi:
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      Penny A Asbell, Algis J Vingrys, Jacqueline Tan, Philip Lee Shettle, Eugene B McLaurin, Abayomi Ogundele, Laura Elizabeth Downie, Gary Jenkins; Fixed versus pro-re-nata dosing of polyethylene glycol/propylene glycol-based artificial tears: A randomized clinical trial. Invest. Ophthalmol. Vis. Sci. 2017;58(8):2685.

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

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Purpose : Artificial tears are usually dosed on an as needed basis (PRN). This study evaluated the clinical benefits of a fixed (4 times daily/QID) versus PRN dosing of polyethylene glycol/propylene glycol (PEG/PG)-based artificial tears (Systane®Ultra) in patients with dry eye disease (DED).

Methods : This was a phase IV, prospective, randomized (1:2), multicenter, observer-masked, active-control, parallel-group study (NCT02446015). Patients with DED, ≥18 years old, with a total ocular staining score (TOSS) of ≥4 to ≤9 on the 15-point Oxford scale were eligible. Patients instilled 1 drop of PEG/PG either QID or PRN for 28 days. The primary endpoint was the change from baseline in the TOSS score at Day 28 (superiority of QID to PRN was established if the upper limit of one-sided 95% confidence interval [CI] for least square mean difference [QID−PRN] was <0). Change from baseline in Impact of Dry Eye on Everyday Life (IDEEL) scores for symptom-bother (SB), treatment effectiveness (TE) and inconvenience (TI) were also assessed.

Results : Of the 101 patients randomized, 97 (QID=34; PRN=63) received treatment; mean age±SD was 50.4±17.7 years and 79.4% of patients were female. At Day 28, TOSS score decreased for both groups; the TOSS score change (mean±SE) from baseline was -1.19±0.26 in QID and -0.94±0.24 PRN groups (treatment difference:-0.26±0.28; 95% CI=-∞ to 0.21; p=0.184). At Day 28, the change from baseline in IDEEL SB score (mean±SE) was -7.0±2.01 in QID and -2.94±1.85 in PRN groups with a treatment difference of -4.06±2.25 (p=0.037). The treatment difference between QID and PRN groups for IDEEL TE score was 2.28±3.84 (p=0.277) and IDEEL TI score was -8.8±3.21 (p=0.996). A negative correlation was observed for change from baseline in TOSS score and (1) TE score (r=-0.405; p=0.019), and (2) TI score (r=-0.239; p=0.18), only in the QID group. Adverse events (AEs) were reported by 2.9% and 3.2% of patients in the QID and the PRN groups, respectively. No serious AEs were reported.

Conclusions : PEG/PG eye drops, instilled QID or PRN, were well tolerated and reduced ocular staining (TOSS). While patient-rated inconvenience was higher, the SB score improved notably with QID dosing suggesting that the regular use of artificial tears may provide better symptomatic relief. Further evaluation of fixed dosing may be helpful to determine best dosing for symptom relief in DED.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.


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