Back to Journals » Clinical Ophthalmology » Volume 13

A randomized controlled trial of povidone-iodine/dexamethasone ophthalmic suspension for acute viral conjunctivitis

Authors Pepose JS, Narvekar A, Liu W, Haque R

Received 31 October 2018

Accepted for publication 31 January 2019

Published 21 March 2019 Volume 2019:13 Pages 535—544

DOI https://doi.org/10.2147/OPTH.S191275

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Amy Norman

Peer reviewer comments 2

Editor who approved publication: Dr Scott Fraser


Jay S Pepose,1,2 Abhijit Narvekar,3 Wenlei Liu,4 Reza Haque3

1Pepose Vision Institute, Chesterfield, MO, USA; 2Department of Ophthalmology and Visual Sciences, Washington University School of Medicine, St Louis, MO, USA; 3Ophthalmics, Shire, A Takeda Company, Lexington, MA, USA; 4Biostatistics and Programming, Shire, A Takeda Company, Lexington, MA, USA

Purpose: To evaluate the clinical safety and efficacy of povidone-iodine (PVP-I) 0.6%/dexamethasone (DEX) 0.1% ophthalmic suspension vs vehicle in patients with clinically suspected acute viral conjunctivitis.
Patients and methods: This was a randomized, double-masked, parallel-group, vehicle-controlled study. Adults with a clinical diagnosis of suspected acute viral conjunctivitis were randomized 1:1 to PVP-I/DEX ophthalmic suspension or vehicle bilaterally four times daily for 5 days (Days 1–5). Evaluation was on Days 1, 3 (+1-day window), and 6 (+1). Patients with signs of acute viral conjunctivitis at the Day 6 visit received open-label PVP-I/DEX for five additional days and were evaluated on Day 11–14. The primary efficacy endpoint was clinical resolution of acute viral conjunctivitis in the study eye at the Day 6 visit.
Results: Overall, 132 patients were randomized and received treatment (PVP-I/DEX, n=66; vehicle, n=66); 38 patients continued into the open-label portion of the study. Not enough patients with confirmed adenoviral conjunctivitis (n=32/132) were enrolled to assess the primary endpoint, although there were some efficacy trends in the PVP-I/DEX group for global clinical score (sum of watery conjunctival discharge and bulbar conjunctival redness). There were no serious treatment-emergent adverse events (TEAEs) and no patients discontinued due to a TEAE. In the masked phase, 56.1% of patients receiving PVP-I/DEX experienced at least one TEAE vs 43.9% in the vehicle group; 78.9% of patients in the open-label phase experienced at least one TEAE. Most TEAEs were mild in severity.
Conclusion: PVP-I/DEX ophthalmic suspension administered for ≤14 days had a favorable safety profile and was generally well tolerated.

Keywords: adenoviral conjunctivitis, dexamethasone, povidone-iodine, randomized controlled trial

Creative Commons License This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Download Article [PDF]  View Full Text [HTML][Machine readable]