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

Abstract

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.

Figure 1

Study design. Abbreviations: DEX, dexamethasone; PVP-I, povidone-iodine.

Figure 2

Patient disposition. Notes: The viral-positive population consisted of all patients in the modified ITT population with a positive viral test at Visit 1 in either eye by any method (Rapid Pathogen Screening, cell culture immunofluorescence assay, and/or quantitative polymerase chain reaction). Abbreviations: DEX, dexamethasone; ITT, intention-to-treat; PVP-I, povidone-iodine.

Figure 3

Adenovirus detection in the modified ITT population. Notes: There were no significant differences in detected adenovirus between treatment groups at all visits. Positive is defined as ≥100 copies/mL for quantitative PCR and “detected” virus for CC-IFA. Percentages are based on the number of eyes in each group with reported results. Values inside bars = number of eyes with positive result/total number of eyes in each group with reported results. Abbreviations: CC-IFA, cell culture immunofluorescence assay; DEX, dexamethasone; ITT, intention-to-treat; PCR, polymerase chain reaction; PVP-I, povidone-iodine.