March 2012
Volume 53, Issue 14
Free
ARVO Annual Meeting Abstract  |   March 2012
The Effect Of A New lipid-based Eye drop And Its Interaction With The Lipid Layer
Author Affiliations & Notes
  • Cecile A. Maissa
    OTG Research & Consultancy, London, United Kingdom
  • Michel Guillon
    OTG Research & Consultancy, London, United Kingdom
  • Benjamin Bossard
    OTG Research & Consultancy, London, United Kingdom
  • Footnotes
    Commercial Relationships  Cecile A. Maissa, Allergan (F), Allergan, Alcon (C); Michel Guillon, Allergan (F), Allergan, Alcon (C); Benjamin Bossard, Allergan (F)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science March 2012, Vol.53, 4251. doi:
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      Cecile A. Maissa, Michel Guillon, Benjamin Bossard; The Effect Of A New lipid-based Eye drop And Its Interaction With The Lipid Layer. Invest. Ophthalmol. Vis. Sci. 2012;53(14):4251.

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

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Abstract

Purpose: : A new oil-in-water aqueous eye drop has been developed to deliver lipid and water to the eye along with the established lubricant carboxymethylcellulose, in order to replenish deficient aqueous and lipid components and stabilise the tear film. The study objective was to assess the effect of the repeated usage of this new eye drop.

Methods: : The study was a one-month duration, prospective, bilateral evaluation of the beneficial effects of the lipid-based eye drop (Optive® Plus, Allergan) on evaporative dry eye sufferers. The subjects attended at two occasions (Baseline - dispensing visit and follow-up 30 days later) both times having not used any eye drop for at least three hours. At both visits the eye drop was inserted and its effects measured up to 120 minutes post instillation and compared with pre-instillation (Basal status). Eye drop residency was monitored by the quantification of castor oil (a lipid component) in 2ul of non-reflex tear samples analysed by HPLC. The population symptomatology status was determined by the OSDI© questionnaire. Subjective comfort was evaluated on a 0 to 100 VAS scale.

Results: : Out of 40 subjects successfully enrolled, 35 subjects completed the study and 33 had valid data for castor oil analysis. The results show that: i. A single instillation of the eye drop on the untreated eye produced a significant increase in the concentration of castor oil in the tear film up to 2 hours (T60 p<0.001; T120 p=0.013). ii. Further, the basal concentration of castor oil was significantly greater (mean increase > 9x) at the follow-up visit (0.064 vs.0.007 nl/ul of tears, p=0.013), indicating a cumulative effect with repeated use. iii. The long lasting functionality of the lipid-based eye drop, demonstrated by the change in castor oil concentration in the basal tears, resulted in a significant decrease in dry eye symptomatology (OSDI p<0.001) and a significant increase in ocular comfort after one month of use (70.4 vs. 47.1 p<0.001).

Conclusions: : This new lipid-based eye drop was highly effective in relieving symptomatology in evaporative dry eye sufferers, which we hypothesize is due to the long term supplementation of the native tear film lipids in combination with the lubrication and hydration provided by the aqueous components.

Clinical Trial: : http://www.clinicaltrials.gov NCT01339936

Keywords: cornea: tears/tear film/dry eye • lipids • clinical laboratory testing 
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