June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
A Phase I/II clinical study evaluating the safety and efficacy of bilaterally dosed topical lipoic acid choline ester eye drops for the treatment of presbyopia
Author Affiliations & Notes
  • Michael Stanton Korenfeld
    Ophthalmology and Visual Sciences, Washington University, St. Louis, Missouri, United States
    Ophthalmology and Visual Sciences, Comprehensive Eye Care, Ltd, Washington, Missouri, United States
  • David G Evans
    Total Eye Care, PA, Memphis, Tennessee, United States
  • Steven H Rauchman
    North Valley Eye Medical Group, Mission Hills, California, United States
  • Kenneth N Sall
    Sall Research Medical Center, Artesia, California, United States
  • Jerry M Stein
    Summer Creek Consulting, LLC, Fort Worth, Texas, United States
  • Stella M Robertson
    Arrochar Consulting, LLC, Fort Worth, Texas, United States
  • Travis Whitfill
    Bios Partners, Fort Worth, Texas, United States
  • Judy Gordon
    ClinReg Consulting Services, Inc, Laguna Beach, California, United States
  • William Burns
    Encore Vision, Inc, Fort Worth, Texas, United States
  • Adrian Glasser
    Adrian Glasser Consulting Services, Tampa, Florida, United States
  • Footnotes
    Commercial Relationships   Michael Korenfeld, Encore Vision, Inc (I); David Evans, None; Steven Rauchman, None; Kenneth Sall, None; Jerry Stein, Encore Vision, Inc (C); Stella Robertson, Encore Vision, Inc (I), Encore Vision, Inc (C); Travis Whitfill, Encore Vision, Inc (I), Encore Vision, Inc (C); Judy Gordon, Encore Vision, Inc (C); William Burns, Encore Vision, Inc (I), Encore Vision, Inc (E); Adrian Glasser, Encore Vision, Inc (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 331. doi:
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      Michael Stanton Korenfeld, David G Evans, Steven H Rauchman, Kenneth N Sall, Jerry M Stein, Stella M Robertson, Travis Whitfill, Judy Gordon, William Burns, Adrian Glasser; A Phase I/II clinical study evaluating the safety and efficacy of bilaterally dosed topical lipoic acid choline ester eye drops for the treatment of presbyopia. Invest. Ophthalmol. Vis. Sci. 2017;58(8):331.

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

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Abstract

Purpose : There are no currently approved pharmacological therapies designed to treat presbyopia, a condition thought to be related to an increased number of crystalline lens disulfide bonds, which leads to a loss of lens flexibility. Lipoic acid is an antioxidant shown to chemically reduce lens disulfide bonds, which results in greater cytosol displacement during accommodation, and increased dynamic lens refractive power. This first-in-man, Phase I/II study was designed to evaluate the topical bilateral use of a lipoic acid choline ester formulation (EV06 Ophthalmic Solution, 1.5%) on distance corrected near visual acuity (DCNVA) in a sample of presbyopes.

Methods : Subjects were recruited at 4 sites for this randomized, double-masked, placebo-controlled study. The 75 generally healthy 45-55 year old subjects all met eligibility criteria, including DCNVA worse than 20/40 in each eye and manifest refraction spherical equivalent between, or equal to, +4.0D to -4.0D. DCNVA was assessed using ETDRS charts (M&S System). Following informed consent, subjects were randomized to EV06(n=50) or Placebo(n=25). On Days 1-7, subjects were dosed BID in one eye to ensure safety prior to Days 8–91, when dosing was BID bilaterally.

Results : Acceptable safety and comfort were observed. 72 of 75 randomized subjects completed the study (EV06 n=49; Placebo n=23). No subjects discontinued for drug related ocular adverse events. Clinically significant improvements in bilateral DCNVA (change in DCNVA from Day 1, baseline) were observed in the EV06 Group compared to the Placebo Group, with the onset of statistically significant differences in DCNVA OU beginning on Day 8 (Placebo vs EV06, mean±SEM: 0.035±0.013 vs 0.084±0.016 LogMAR; p=0.024) and continuing throughout the 3-month study (Day 91: 0.089±0.020 vs 0.189±0.019 LogMAR; p=0.001). The percentage of subjects with DCNVA OU of 20/32 or better at baseline was 8.0% in both EV06 and Placebo Groups (p=1.00) compared to 61.2% and 26.1% on Day 91 (p=0.011), respectively. There were no clinically or statistically significant changes in best corrected distance visual acuity, pupil size or intraocular pressure.

Conclusions : These Phase I/II study results suggest that EV06 Ophthalmic Solution is safe and effective for the treatment of presbyopia.

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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