June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Efficacy and safety of dexamethasone/povidone-iodine ophthalmic suspension in adenoviral conjunctivitis
Author Affiliations & Notes
  • Reza M Haque
    Shire , Lexington, Massachusetts, United States
  • Arjun Ahuja
    Seth GS Medical College & K.E.M. Hospital, Mumbai, India
  • Wenlei Liu
    Shire , Lexington, Massachusetts, United States
  • Abhijit Narvekar
    Shire , Lexington, Massachusetts, United States
  • Footnotes
    Commercial Relationships   Reza Haque, Shire (E); Arjun Ahuja, None; Wenlei Liu, Shire (E); Abhijit Narvekar, Shire (E)
  • Footnotes
    Support  This study was funded by Foresight Biotherapeutics, a member of the Shire group of companies.
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 3602. doi:
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    • Get Citation

      Reza M Haque, Arjun Ahuja, Wenlei Liu, Abhijit Narvekar; Efficacy and safety of dexamethasone/povidone-iodine ophthalmic suspension in adenoviral conjunctivitis. Invest. Ophthalmol. Vis. Sci. 2017;58(8):3602.

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

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Abstract

Purpose : There are no approved treatments for acute, adenoviral conjunctivitis. The efficacy and safety of an ophthalmic suspension (0.1% dexamethasone/0.6% povidone-iodine [PVP-I]) in the treatment of acute adenoviral conjunctivitis was evaluated in a multicenter, randomized, double-masked parallel-group, active- and vehicle-controlled phase II study.

Methods : 176 patients ≥ 18 years old were randomized 1:1:1 to dexamethasone/PVP-I suspension (n=59), PVP-I (n=59) or vehicle (n=58) after a positive Rapid Pathogen Screening Adeno Detector Plus test. One drop of study treatment was applied to both eyes four times daily x 5 days. The initial drop was administered in the office on Day 1. Additional office visits occurred on Day 3, 6, and 12 (+1 day window allowed). Safety measures included slit lamp biomicroscopy, visual acuity, and adverse events (AEs). Main efficacy measures included clinical resolution (defined as absence of watery conjunctival discharge and bulbar conjunctival redness) and adenoviral eradication (negative cell culture immunofluorescence assay [CC-IFA]). Efficacy endpoints were compared between treatment arms using Pearson’s chi-square or Fisher’s exact tests (in the case of expected counts<5) at two sided 0.05 significance level with missing data imputed by last observation carried forward method.

Results : The mean (SD) age of subjects was 34.5 (12.2). Most patients were male (66.3%) and all were Asian. A total of 124 patients completed the study. After 5 days of treatment, clinical resolution and adenoviral eradication in the primary study eye at the Day 6 visit were greater with dexamethasone/PVP-I (31.3% [15/48]; 79.2%[38/48]) compared with the vehicle (10.9% [5/46]; 56.5%[26/46]); p<0.05 for both). Resolution and eradication with PVP-I were 18.0% (9/50) and 62.0% (31/50), respectively; p=NS compared with dexamethasone/PVP-I or with vehicle. Adenoviral eradication was evident as early as Day 3 in both dexamethasone/PVP-I and PVP-I. Thirty-seven patients withdrew owing to AEs (dexamethasone/PVP-I, n=9; PVP-I, n=12; vehicle, n=16). Proportion of subjects with treatment-emergent AEs was highest in the vehicle group (69.0% [40/58] followed by PVP-I (62.7% [37/59]) and dexamethasone/PVP-I (53.4% [31/58]).

Conclusions : Study results suggest dexamethasone/PVP-I ophthalmic suspension was efficacious and safe to use in the treatment of adenoviral conjunctivitis in adults.

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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