PMID- 29787732
OWN - NLM
STAT- MEDLINE
DCOM- 20190830
LR  - 20220408
IS  - 1879-1891 (Electronic)
IS  - 0002-9394 (Linking)
VI  - 194
DP  - 2018 Oct
TI  - Randomized, Controlled, Phase 2 Trial of Povidone-Iodine/Dexamethasone Ophthalmic 
      Suspension for Treatment of Adenoviral Conjunctivitis.
PG  - 7-15
LID - S0002-9394(18)30222-8 [pii]
LID - 10.1016/j.ajo.2018.05.012 [doi]
AB  - PURPOSE: 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. DESIGN: Multicenter, randomized, vehicle-controlled, 
      double-masked trial. METHODS: 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. RESULTS: 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). CONCLUSION: 
      PVP-I/dexamethasone appeared safe and well tolerated, and significantly improved 
      clinical resolution and adenoviral eradication in patients with acute adenoviral 
      conjunctivitis.
CI  - Copyright (c) 2018 Shire, Lexington, MA, USA. Published by Elsevier Inc. All rights 
      reserved.
FAU - Pepose, Jay S
AU  - Pepose JS
AD  - Pepose Vision Institute, Chesterfield, Missouri, USA; Department of Ophthalmology 
      and Visual Sciences, Washington University School of Medicine, St. Louis, 
      Missouri, USA.
FAU - Ahuja, Arjun
AU  - Ahuja A
AD  - Seth Gordhandas Sunderdas Medical College and King Edward Memorial Hospital, 
      Mumbai, India.
FAU - Liu, Wenlei
AU  - Liu W
AD  - Shire, Lexington, Massachusetts, USA.
FAU - Narvekar, Abhijit
AU  - Narvekar A
AD  - Shire, Lexington, Massachusetts, USA.
FAU - Haque, Reza
AU  - Haque R
AD  - Shire, Lexington, Massachusetts, USA. Electronic address: rhaque@shire.com.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180519
PL  - United States
TA  - Am J Ophthalmol
JT  - American journal of ophthalmology
JID - 0370500
RN  - 0 (Anti-Infective Agents, Local)
RN  - 0 (Glucocorticoids)
RN  - 0 (Ophthalmic Solutions)
RN  - 7S5I7G3JQL (Dexamethasone)
RN  - 85H0HZU99M (Povidone-Iodine)
SB  - IM
CIN - Am J Ophthalmol. 2019 Jan;197:184. PMID: 30389099
CIN - Am J Ophthalmol. 2019 Jan;197:184-185. PMID: 30390919
CIN - Am J Ophthalmol. 2019 Aug;204:140. PMID: 31235065
CIN - Am J Ophthalmol. 2019 Sep;205:197. PMID: 31327463
MH  - Acute Disease
MH  - Adenovirus Infections, Human/diagnosis/*drug therapy/physiopathology
MH  - Adenoviruses, Human/drug effects/isolation & purification
MH  - Administration, Ophthalmic
MH  - Adult
MH  - Anti-Infective Agents, Local/adverse effects/*therapeutic use
MH  - Conjunctivitis, Viral/diagnosis/*drug therapy/physiopathology
MH  - Dexamethasone/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glucocorticoids/adverse effects/*therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Ophthalmic Solutions
MH  - Povidone-Iodine/adverse effects/*therapeutic use
MH  - Prospective Studies
MH  - Treatment Outcome
EDAT- 2018/05/23 06:00
MHDA- 2019/08/31 06:00
CRDT- 2018/05/23 06:00
PHST- 2018/02/01 00:00 [received]
PHST- 2018/05/08 00:00 [revised]
PHST- 2018/05/10 00:00 [accepted]
PHST- 2018/05/23 06:00 [pubmed]
PHST- 2019/08/31 06:00 [medline]
PHST- 2018/05/23 06:00 [entrez]
AID - S0002-9394(18)30222-8 [pii]
AID - 10.1016/j.ajo.2018.05.012 [doi]
PST - ppublish
SO  - Am J Ophthalmol. 2018 Oct;194:7-15. doi: 10.1016/j.ajo.2018.05.012. Epub 2018 May 
      19.