June 2020
Volume 61, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2020
Effect of cyclosporine ophthalmic solution 0.09% on conjunctival staining in patients with keratoconjunctivitis sicca
Author Affiliations & Notes
  • Abayomi B Ogundele
    Sun Pharmaceutical Industries, Inc., Princeton, New Jersey, United States
  • Paul Karpecki
    Kentucky Eye Institute, Kentucky, United States
  • Douglas Devries
    Eye Care Associates of Nevada, Nevada, United States
  • Charles Darby
    Sun Pharma Advanced Research Company Ltd., New Jersey, United States
  • Jodi Luchs
    Florida Vision Institute, Florida, United States
  • Footnotes
    Commercial Relationships   Abayomi Ogundele, Sun Pharmaceutical Industries Inc. (E); Paul Karpecki, Aerie (F), Akorn (F), Alcon (F), Allergan (F), Allysta (F), Avellino Labs (F), Azura Pharmaceuticals (F), Bausch & Lomb (F), Bio-Tissue (F), Blephex (F), Bruder (F), Cambium (F), EyeBrain/Neurolens (F), EyeGate Pharma (F), Eyevance (F), Imprimis (F), Jobson Medical Information/Web MD (F), Johnson & Johnson Vision (F), Nevakar (F), Novaliq (F), Oasis Medical (F), Ocular Sciences (F), Oculus (F), OcuMedic (F), Sun Pharmaceutical Industries, Inc. (F); Douglas Devries, Akorn (F), Alcon (F), Allergan (F), Bausch & Lomb (F), Bio Tissue (F), Bruder (I), BVI Medical (F), Eye 4 Lives (F), Johnson & Johnson Vision (Abbott Medical Optics) (F), OcuSoft (F), Ophthalmic Resources (F), Revision Optics (F), RPS (I), RySurg (F), Science Based Health (F), Shire (F), Sun Pharmaceutical Industries, Inc. (F), TearLab (F), Tear Science (F), VMax Vision (F); Charles Darby, Sun Pharmaceutical Industries, Inc. (E); Jodi Luchs, Alcon (F), Allergan (F), Bausch & Lomb (F), Calhoun Vision (F), CLXO (F), Insightful Solutions (F), Shire (F), Sun Pharmaceutical Industries, Inc. (F), Tear Lab (F), Trefoil Therapeutics (F)
  • Footnotes
    Support  Sun Pharmaceutical Industries, Inc.
Investigative Ophthalmology & Visual Science June 2020, Vol.61, 115. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Abayomi B Ogundele, Paul Karpecki, Douglas Devries, Charles Darby, Jodi Luchs; Effect of cyclosporine ophthalmic solution 0.09% on conjunctival staining in patients with keratoconjunctivitis sicca. Invest. Ophthalmol. Vis. Sci. 2020;61(7):115.

      Download citation file:


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

      ×
  • Supplements
Abstract

Purpose : The severity of keratoconjunctivitis sicca (KCS) can be indicated with conjunctival staining. OTX-101 0.09% is approved in the United States to increase tear production in patients with KCS. This pooled analysis of phase 2b/3 and phase 3 studies examines the effect of OTX-101 on conjunctival staining in the worse eye.

Methods : In these randomized, double-masked studies, patients self-administered 1 drop OTX-101 or vehicle in both eyes twice daily. Conjunctival staining was performed at screening, baseline, and common study days 28, 56, and 84. Zones 1 (temporal), 3 (inferior temporal), 5 (inferior nasal) , and 6 (nasal) of the conjunctiva were scored from 0–3 points (0 = no stain, 3 = densely concentrated micropuntate stain spots). Worse eye was defined as the eye with lower Schirmer’s score at baseline, or right eye if equal. Adverse events (AE) were reported throughout both studies.

Results : For zones 1, 3, 5, and 6, the baseline mean conjunctival score (standard deviation) for OTX-101 (n = 523) vs vehicle (n = 525) was 1.0 (0.7) vs 1.1 (0.8), 1.5 (0.7) vs 1.5 (0.7), 1.6 (0.7) vs 1.6 (0.8), and 1.5 (0.8) vs 1.5 (0.7), respectively. At day 28, the least square (LS) mean percent change from baseline (standard error [SE]) for zones 3 and 5 for OTX-101 vs vehicle was −14.1 (2.1) vs −8.1 (2.1) and −13.1 (2.2) vs −5.5 (2.2), respectively; P = 0.0429 and P = 0.0144, respectively. At day 56, the LS mean percent change from baseline (SE) for zones 1, 3, and 5 for OTX-101 vs vehicle were −37.2 (3.2) vs −28.1 (3.1), −21.6 (2.3) vs −10.5 (2.3), and −23.2 (2.2) vs −11.0 (2.2), respectively; P = 0.0405, P = 0.0007, and P <0.0001, respectively. At day 84, the LS mean percent change from baseline (SE) for zones 1, 3, and 5 conjunctival scores for OTX-101 vs vehicle were −41.5 (3.3) vs −31.1 (3.2), −25.5 (2.4) vs −13.3 (2.3), and −25.0 (2.4) vs −13.5 (2.4), respectively; P = 0.0235, P = 0.0003, and P = 0.0006, respectively. Pooled safety analysis (n = 524 per arm) showed most AEs were mild; instillation site pain was most common AE (21.8% vs 4.0% for OTX-101 and vehicle, respectively).

Conclusions : OTX-101 0.09% significantly improved conjunctival surface integrity in patients with KCS, with a difference seen as early as day 28 (zones 3 and 5) and day 56 (zone 1) in 3 of the 4 individual zones. OTX-101 0.09% was well tolerated.

This is a 2020 ARVO Annual Meeting abstract.

×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×