povidone-iodine and Adenovirus-Infections--Human

The effectiveness of masking is rarely evaluated or reported in single- or double-masked clinical trials. Knowledge of treatment assignment by participants and clinicians can bias the assessment of treatment efficacy.. This study aimed to evaluate the effectiveness of masking in a double-masked trial of 5% povidone-iodine for the treatment of adenoviral conjunctivitis.. The Reducing Adenoviral Patient Infected Days study is a double-masked, randomized trial comparing a one-time, in-office administration of 5% povidone-iodine with artificial tears for the treatment of adenoviral conjunctivitis. Masking was assessed by asking participants and masked clinicians at designated time points if they believed the treatment administered was povidone-iodine or artificial tears, or if they were unsure. Adequacy of masking was quantified using a modified Bang Blinding Index.. Immediately after treatment, 34% of participants who received povidone-iodine and 69% of those who received artificial tears guessed incorrectly or were unsure of their treatment (modified Bang Indices of 0.31 and -0.38, respectively). On day 4, 38% of the povidone-iodine participants and 52% of the artificial tear participants guessed incorrectly or were unsure of their treatment (modified Bang Indices of 0.24 and -0.05, respectively), indicating adequate and ideal masking. On days 1, 4, 7, 14, and 21, masked clinicians guessed incorrectly or were unsure of treatment in 53%, 50%, 40%, 39%, and 42% among povidone-iodine participants compared with 44%, 35%, 38%, 35%, and 39% among artificial tears participants, respectively. The modified Bang Indices for clinician masking in the povidone-iodine group ranged from -0.05 to 0.25 and from 0.13 to 0.29 in the artificial tears group.. Masking of participants and clinicians was adequate. Successful masking increases confidence that subjective measurements are not biased. We recommend quantitative assessment and reporting the effectiveness of masking in ophthalmic clinical trials.

Topics: Adenovirus Infections, Human; Administration, Ophthalmic; Adolescent; Adult; Anti-Infective Agents, Local; Conjunctivitis, Viral; Double-Blind Method; Eye Infections, Viral; Female; Humans; Lubricant Eye Drops; Male; Ophthalmic Solutions; Pilot Projects; Povidone-Iodine; Treatment Outcome; Young Adult

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.. Multicenter, randomized, vehicle-controlled, double-masked trial.. Adults with a positive Rapid Pathogen Screening Adeno-Detector Plus test were randomized 1:1:1 to PVP-I 0.6%/dexamethasone 0.1%, PVP-I 0.6%, or vehicle, bilaterally 4 times daily for 5 days (days 1-5). Patients were evaluated on days 3, 6, and 12 (+1-day window). Efficacy measures included clinical resolution and adenoviral eradication.. Overall, 144 patients were included in the efficacy analysis (PVP-I/dexamethasone, n = 48; PVP-I, n = 50; vehicle, n = 46). The proportion of patients with clinical resolution (primary study eye with last observation carried forward [LOCF]) at the day 6 visit was higher with PVP-I/dexamethasone (31.3%) than with vehicle (10.9%; P = .0158) and PVP-I (18.0%; P = nonsignificant). The proportion with adenoviral eradication (primary study eye with LOCF) was higher with PVP-I/dexamethasone than with vehicle at the day 3 (35.4% vs 8.7%; P = .0019) and day 6 (79.2% vs 56.5%; P = .0186) visits and vs PVP-I (day 3 visit, 32.0%; day 6 visit, 62.0%; each P = nonsignificant). 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 dataset. Discontinuation owing to AEs occurred in 37 patients (vehicle, n = 16; PVP-I, n = 12; PVP-I/dexamethasone, n = 9).. PVP-I/dexamethasone appeared safe and well tolerated, and significantly improved clinical resolution and adenoviral eradication in patients with acute adenoviral conjunctivitis.

Topics: Acute Disease; Adenovirus Infections, Human; Adenoviruses, Human; Administration, Ophthalmic; Adult; Anti-Infective Agents, Local; Conjunctivitis, Viral; Dexamethasone; Double-Blind Method; Drug Therapy, Combination; Female; Glucocorticoids; Humans; Male; Middle Aged; Ophthalmic Solutions; Povidone-Iodine; Prospective Studies; Treatment Outcome

The objective of this pilot study was to determine the preliminary efficacy of a novel ophthalmic suspension containing povidone-iodine 0.4% and dexamethasone 0.1% in the treatment of adenoviral conjunctivitis.. A prospective, open-label, single-armed, phase II clinical trial in humans. Eligible patients with the clinical signs and symptoms of acute conjunctivitis who tested positive for adenoviral antigen by Rapid Pathogen Screening (RPS) Adeno Detector were enrolled in a single treatment arm consisting of a combination povidone-iodine 0.4%/dexamethasone 0.1% sterile ophthalmic suspension given four times daily for a minimum of 5 days. RPS Adeno Detector testing was performed at baseline and at each follow-up visit along with ocular fluid sampling by conjunctival swabs. Subsequent analysis performed on all swabs included both adenoviral titer by quantitative polymerase chain reaction (qPCR) and cell culture with confirmatory immunofluorescence (CC-IFA). The primary endpoint was clinical resolution of conjunctival injection and discharge. Secondary measures included reduction of qPCR titers and eradication of infectious virus as determined by CC-IFA.. A total of nine eyes of six patients with clinical signs and symptoms of acute viral conjunctivitis and a positive RPS Adeno Detector test result were enrolled in the study. In eight/nine eyes enrolled in the study, clinical resolution was observed by day 3 or day 4. In six/six eyes with detectable adenovirus by qPCR, significant reduction in viral titer was seen by day 3, day 4, or day 5. In five/six eyes with infectious virus confirmed by CC-IFA at enrollment, elimination of infectivity was achieved by day 4 or day 5. One patient was lost to followup.. An ophthalmic suspension containing povidone-iodine 0.4% and dexamethasone 0.1% may be a useful agent in the treatment of acute RPS Adeno Detector-positive conjunctivitis. A further placebo-controlled study with a larger number of patients is warranted.

Topics: Acute Disease; Adenovirus Infections, Human; Anti-Infective Agents, Local; Anti-Inflammatory Agents; Conjunctivitis, Viral; Dexamethasone; Drug Administration Schedule; Drug Combinations; Fluorescent Antibody Technique; Humans; Ophthalmic Solutions; Pilot Projects; Polymerase Chain Reaction; Povidone-Iodine; Prospective Studies; Treatment Outcome

150 patients with adenovirus type 8 infection where treated at random, in a prospective study. Based upon a quantifiable conjunctivitis severity score we tried to find out where there are differences in treatment. The best results were seen using polyvinylpyrrolidone-iodine (Betaisodona) although it could not prevent totally subepithelial corneal infiltrates. The combination of exogenous interferon alpha with polyvinylpyrrolidone-iodo-drops or trifluorothymidine-drops was less successful. We could not show any prophylactic effect of interferon on uninflamed fellow eyes. Treatment with vasoconstrictor did not show any therapeutic or prophylactic potency. This group of patients must be seen as a control group and the results of effective therapy should significantly differ from the results in this group. Topical corticosteroids should be reserved for severe symptomatic cases and those with iritis and pseudomembranous conjunctivitis. Giving topical corticosteroids in combination with antibiotics we did not find any influence on the incidence of subepithelial keratitis or the number of corneal infiltrates. The mean duration of acute keratoconjunctivitis using this therapy was longer than the mean duration in the control group with vasoconstrictor.

Topics: Acrylic Resins; Adenovirus Infections, Human; Adolescent; Adult; Aged; Aged, 80 and over; Child; Child, Preschool; Dexamethasone; Disease Outbreaks; Drug Therapy, Combination; Eye Infections, Viral; Gentamicins; Humans; Interferons; Keratoconjunctivitis; Middle Aged; Ophthalmic Solutions; Oxymetazoline; Povidone-Iodine; Prospective Studies; Trifluridine

Topics: Adenovirus Infections, Human; Administration, Ophthalmic; Adolescent; Anti-Infective Agents, Local; Antiviral Agents; Child; Drug Synergism; Eye Infections, Viral; Female; Ganciclovir; Humans; Immunoassay; Keratoconjunctivitis; Male; Ophthalmic Solutions; Povidone-Iodine; Retrospective Studies

To compare the efficacy of classical treatment and povidone-iodine treatment for adenoviral conjunctivitis.. This retrospective study was conducted at the Centre of Marmara Eye Health, Sakarya, Turkey, between January 2011 and February 2014, and comprised adult patients suffering from adenoviral conjunctivitis. The participants were randomly divided into two groups. Group I was given povidone-iodine solution while Group II was given the classical treatment and was taken as control. Povidone-iodine treatment was administered as three drops three times per day. The classical treatment comprised three drops of trifluorothymidine three times per day. Treatment were continued for two weeks. The patients who had not recovered in this time frame were defined as 'late recovering' patients. SPSS 23 was used for data analysis.. Of the 112 participants, there were 56(50%) in each group. In Group I, 54(96.4%) patients recovered in two weeks, while 2(3.6%) took more time. In Group II, 33(58.9%) patients recovered in two weeks while 23(41.1%) took more time (p<0.001). Overall, 92(82.1%) patients had familial transmission-contamination.. A new treatment protocol of povidone-iodine was used safely in patients with adenoviral conjunctivitis. Familial transmission was found very important to adenoviral conjunctivitis infection.

Topics: Adenovirus Infections, Human; Adult; Anti-Infective Agents, Local; Antiviral Agents; Conjunctivitis, Viral; Humans; Povidone-Iodine; Retrospective Studies; Time Factors; Trifluridine