Phaco Training: Paper from American Journal of Ophthalmology on Adenoviral Conjunctivitis

Synopsis Adenoviral Conjunctivitis is a common condition affecting a majority of the population but there are no approved medications for the treatment of adenoviral conjunctivitis. The present study aims to evaluate the efficacy/safety of an ophthalmic suspension of povidone-iodine (PVP-I) 0.6% and dexamethasone 0.1% in patients with acute adenoviral conjunctivitis. This week’s “MED FACT” discusses a clinical study from The American Journal of Ophthalmology, “Randomized, Controlled, Phase 2 Trial of Povidone-Iodine/Dexamethasone Ophthalmic Suspension for Treatment of Adenoviral Conjunctivitis”. Oct 2018.

Authors: Jay S. Pepose et.al.

Key Takeaways: An ophthalmic suspension of PVP-I 0.6% and dexamethasone 0.1% is safe and well tolerated for the treatment of acute adenoviral conjunctivitis.

Objective: To evaluate the efficacy/safety of povidone-iodine (PVP-I) 0.6% and dexamethasone 0.1% in patients with acute adenoviral conjunctivitis.

Study Type: Multicenter, randomized, vehicle-controlled, double-masked trial Participants: 144

What was the need for this study? Currently, there are no medications approved for the treatment of adenoviral conjunctivitis and the available treatment is mostly supportive. So, there is a need to study the efficacy and safety of topical ophthalmic suspension of povidone-iodine (PVP-I) 0.6% and dexamethasone 0.1% in patients with acute adenoviral conjunctivitis.

What Was the study objective? To evaluate the efficacy/safety of povidone-iodine (PVP-I) 0.6% and dexamethasone 0.1% in patients with acute adenoviral conjunctivitis.

Study Methods Study Type Multicenter, randomized, vehicle-controlled, double-masked trial

Number of participants 144 Male & Female Treatment groups PVP-I/Dexamethasone (n= 48) PVP-I (n=50) Vehicle (n=46) Inclusion criteria Age of 18 years and above Signs of adenoviral conjunctivitis within 5 days of 1st visit. Positive Rapid Pathogen Screening Adeno- Detector Plus test at 1st visit Diagnosis of suspected acute adenoviral conjunctivitis in >1 eye Watery conjunctival discharge score of >1 Bulbar conjunctival redness score of >1 Exclusion criteria Pregnant or nursing female Known sensitivity to any of the components of the investigational drugs Presence of an ocular infection or other inflammation IOP steroid responders or H/o glaucoma or IOP>21mmHg H/o recurrent corneal erosion syndrome Significant optic nerve defects Active ulcerative keratitis Autoimmune/uncontrolled systemic/debilitating diseases Outcomes Measurement of clinical resolution or adenoviral eradication Expanded clinical cure Reductions from the global clinical score

What did the treatment include? Patients were randomly assigned in 1:1:1 to PVP-I 0.6%/dexamethasone 0.1% ophthalmic suspension, PVP-I 0.6% alone, or vehicle. One drop of study medication was applied to each eye QID for 5 days. The first dose was administered in the office on day 1 (visit 1), with office visits for efficacy and safety evaluations on day 3 (visit 2), day 6 (visit 3), and day 12 (visit 4), with a +1-day window allowed. The study treatments were provided as sterile, preserved suspensions or solutions in 10-mL amber glass bottles with separate sterile dropper tips for topical ophthalmic administration. What were the important findings? A total of 144 patients were included in the efficacy analysis, including PVP-I/dexamethasone (n =48); PVP-I (n=50); vehicle (n=46). The proportion of patients with clinical resolution at day 6 visit was higher with PVP-I/dexamethasone (31.3%) than with vehicle (10.9%) and PVP-I (18.0%) The proportion with adenoviral eradication was higher with PVP-I/dexamethasone than with vehicle at the day 3 and day 6 visits and vs PVP-I-day 3 visit and day 6 visit. Treatment-emergent adverse events (AEs) occurred in 69.0% (vehicle), 62.7% (PVP-I), and 53.4% (PVP-I/ dexamethasone) of patients in the safety data set.

How beneficial is this study to patients? The results of this study indicate that an ophthalmic suspension of PVP-I 0.6% and dexamethasone 0.1% is safe, well tolerated and significantly improves clinical resolution in the patient with acute adenoviral conjunctivitis.