A Phase 2, Randomized, Controlled Trial of Povidone-Iodine/Dexamethasone Ophthalmic Suspension for the Treatment of Adenoviral Conjunctivitis
Robert D. Gross, MBA, MD; Jay S. Pepose, MD, PhD; Abhijit Narvekar, MBBS, MS; Arjun Ahuja, MBBS, MD; Wenlei Liu, PhD; Reza Haque, MD, PhD
Introduction: Conjunctivitis due to adenovirus or bacterial infection affects both adults and children. Studies demonstrate the potential of an ophthalmic combination of povidone-iodine (PVP-I) and dexamethasone to treat either condition [1,2,3], and provide preclinical evidence of rapid antibacterial efficacy against various gram-positive and gram-negative bacterial isolates. We evaluated efficacy/safety of PVP-I/dexamethasone ophthalmic suspension for acute adenoviral conjunctivitis in adults.
Methods: A multicenter, randomized, double-masked phase 2 study was conducted in adults with a positive Rapid Pathogen Screening Adeno Detector Plus(TM) test. Patients were randomized 1:1:1 to one drop of 0.6% PVP-I/0.1% dexamethasone suspension, 0.6% PVP-I or vehicle bilaterally 4x daily on days 1-5 and evaluated on days 3, 6, and 12 (+1-day window allowed). Main efficacy measures included adenoviral eradication and clinical resolution.
Results: Overall, 144 were included in the primary analysis (n=48 PVP-I/dexamethasone, 50 PVP-I, 46 vehicle). The proportion of patients with adenoviral eradication (primary study eye with last observation carried forward [LOCF]), PVP-I/dexamethasone versus vehicle: day-3 visit, 35.4% versus 8.7% (p<0.01); day-6 visit, 79.2% versus 56.5% (p<0.05); and versus PVP-I: day-3 visit, 32.0% (p=nonsignificant [NS]); day-6 visit, 62.0% (p=NS). Clinical resolution (primary study eye with LOCF): day-6 visit, PVP-I/dexamethasone versus vehicle: 31.3% versus 10.9% (p<0.05). Treatment emergent adverse events (AEs) occurred in 69.0% (vehicle), 62.7% (PVP-I), and 53.4% (PVP-I/dexamethasone) of patients. Discontinuation due to AEs occurred in 37 patients (n=16 vehicle, 12 PVP-I, 9 PVP-I/dexamethasone).
Discussion: PVP-I/dexamethasone ophthalmic suspension was efficacious and safe for adenoviral conjunctivitis in adults.
Conclusion: Ongoing phase 3 studies will evaluate efficacy/safety in children.
References:  Isenberg SJ, Apt L, Valenton M, et al. A controlled trial of povidone-iodine to treat infectious conjunctivitis in children. American journal of ophthalmology. 2002;134:681-688.
 Kovalyuk N, Kaiserman I, Mimouni M, et al. Treatment of adenoviral keratoconjunctivitis with a combination of povidone-iodine 1.0% and dexamethasone 0.1% drops: a clinical prospective controlled randomized study. Acta ophthalmologica. 2017.
 Pelletier JS, Miller D, Liang B, et al. In vitro efficacy of a povidone-iodine 0.4% and dexamethasone 0.1% suspension against ocular pathogens. Journal of cataract and refractive surgery. 2011;37:763-766