June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Reading Performance and Satisfaction with Pilocarpine HCl Ophthalmic Solution 1.25% in Mild Presbyopia: Association with Vision Gains
Author Affiliations & Notes
  • Shane Kannarr
    Kannarr Eye Care LLC, Pittsburg, Kansas, United States
  • Melissa Morrison Toyos
    Toyos Clinic, Memphis, Tennessee, United States
  • Lisa K. Feulner
    Advanced Eye Care, Bel Air, Maryland, United States
  • Frank Zheng
    Lafayette Optometric Group, Lafayette, California, United States
  • Cathleen McCabe
    The Eye Associates, Sarasota, Florida, United States
  • Casey Davis
    Allergan, an AbbVie company, California, United States
  • Zuoyi Zhang
    Allergan, an AbbVie company, California, United States
  • Scott Schachter
    Allergan, an AbbVie company, California, United States
  • Footnotes
    Commercial Relationships   Shane Kannarr Alcon, Allergan (an AbbVie company), Bausch & Lomb, Essilor, Johnson & Johnson, Novartis, Osmotica, Vision Source, Code C (Consultant/Contractor); Melissa Toyos Bausch, Mallinckrodt, Sun, Zeiss, Lumenis, RVL, Oyster Point, Code C (Consultant/Contractor), Bausch, Mallinckrodt, Sun, Zeiss, Greenlight, Kala, Lumenis, DigiSight, RVL, Novartis, Allysta, Biohaven, Recordati, Glaukos, Code F (Financial Support), Bausch, Mallinckrodt, Sun, Lumenis, RVL, Code R (Recipient); Lisa Feulner Aldeyra Therapeutics, Allergan (an AbbVie company), Bruder, Bausch & Lomb, Carl Zeiss Meditech, Novartis, Orasis Pharmaceuticals, Oyster Point Pharma, Sight Sciences, Sun Pharmaceuticals, Tarsus Pharmaceuticals, Thea C, Code C (Consultant/Contractor), RVL/Osmotica, TearClear, Code S (non-remunerative); Frank Zheng Carl Zeiss Meditec, Iris Vision (Radius Xr), Barti, Coopervision, Bausch & Lomb, Code C (Consultant/Contractor); Cathleen McCabe Alcon, Aerie Pharmaceuticals, Bausch & Lomb, Allergan (an AbbVie company), Novartis, Sun Pharmaceuticals, Ziess, Ocular Therapeutix, Sight Sciences, Engage Technologies Group, Science Based Health, Imprimis, Dompe, Tarsus, Visus, Orasis, Quidel, Lensar, iStar Medical, RxSight, Code C (Consultant/Contractor), Alcon, Allergan (an AbbVie company), Johnson & Johnson Vision, Glaukos, Surface Pharma, Code F (Financial Support), Engage Technologies Group, LayerBio, Code I (Personal Financial Interest); Casey Davis AbbVie Inc., Code C (Consultant/Contractor); Zuoyi Zhang AbbVie Inc., Code E (Employment); Scott Schachter AbbVie Inc., Code E (Employment)
  • Footnotes
    Support  Allergan, an AbbVie company
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 2510. doi:
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    • Get Citation

      Shane Kannarr, Melissa Morrison Toyos, Lisa K. Feulner, Frank Zheng, Cathleen McCabe, Casey Davis, Zuoyi Zhang, Scott Schachter; Reading Performance and Satisfaction with Pilocarpine HCl Ophthalmic Solution 1.25% in Mild Presbyopia: Association with Vision Gains. Invest. Ophthalmol. Vis. Sci. 2023;64(8):2510.

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

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Abstract

Purpose : In the randomized, double-masked, phase 3 GEMINI 1 study in presbyopia, pilocarpine hydrochloride ophthalmic solution 1.25% (“Pilo”) improved distance-corrected near visual acuity (DCNVA), and reading performance and associated satisfaction, as assessed with the validated Near Vision Presbyopia Task-based Questionnaire (NVPTQ). This post hoc analysis of participants with mild presbyopia (baseline photopic DCNVA 20/25-20/40) explored the relation between improvements in DCNVA and NVPTQ outcomes.

Methods : Study participants (40-55 years) received bilateral Pilo or vehicle (V) once daily for 30 days. We estimated least square mean changes from baseline (CFB) in mesopic NVPTQ reading performance score (0-5 scale) and satisfaction score (0-4 scale) on Day 14 (Hour 1 postdose) and Day 30 (Hour 3 postdose) in participants stratified by their level of improvement (1, 2 or ≥3 lines) in mesopic DCNVA (dominant eye) on Day 30 (Hour 3 postdose).

Results : Of 323 participants, 153 had mild presbyopia; of these, 34 (Pilo, n=19; V, n=15), 46 (Pilo, n=24; V, n=22), and 29 (Pilo, n=23; V, n=6) achieved 1-, 2-, or ≥3-line improvement in mesopic DCNVA on Day 30. Mean CFB in NVPTQ reading performance score on Days 14 and 30, respectively, was 1.5 and 1.1 with Pilo vs 0.7 and 0.8 with V for participants with 1-line improvement in DCNVA (both P>0.05); 1.6 and 1.4 with Pilo vs 0.0 and 0.4 with V for those with 2-line improvement (P= 0.0002 for Day 14; P=0.0214 for Day 30); and 2.0 and 2.0 with Pilo vs 0.9 and 2.5 with V for those with ≥3-line improvement (both P>0.05). Mean CFB in NVPTQ satisfaction score on Days 14 and 30, respectively, was 1.1 and 0.8 with Pilo vs 0.5 and 0.7 with V for participants with 1-line improvement in DCNVA (both P>0.05); 1.5 and 1.3 with Pilo vs -0.1 and 0.4 with V for those with 2-line improvement (P<0.0001 for Day 14; P=0.0232 for Day 30); and 1.8 and 1.6 with Pilo vs 1.2 and 2.5 with V for those with ≥3-line improvement (both P>0.05).

Conclusions : In mild presbyopes all levels of DCNVA gain (1, 2, ≥3 lines) experienced numerically greater improvements in NVPTQ outcomes with Pilo vs V, with significantly greater improvements in those with 2-line gain (a clinically meaningful response in mild presbyopia). At ≥3-line gain, disparities in NVPTQ outcomes were likely due to the limited size of the V treatment group.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

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