PMID- 30354530
OWN - NLM
STAT- MEDLINE
DCOM- 20200415
LR  - 20200415
IS  - 1460-2202 (Electronic)
IS  - 0271-3683 (Linking)
VI  - 44
IP  - 2
DP  - 2019 Feb
TI  - Novel Dexamethasone Sodium Phosphate Treatment (DSP-Visulex) for Noninfectious 
      Anterior Uveitis: A Randomized Phase I/II Clinical Trial.
PG  - 185-193
LID - 10.1080/02713683.2018.1540707 [doi]
AB  - PURPOSE: Frequent steroid drops represent a challenge in patient compliance. This 
      study evaluated the safety and efficacy of 5 minute topical dexamethasone sodium 
      phosphate-Visulex (DSP-Visulex) treatment regimen (two applications on the first 
      week then weekly after) compared to daily prednisolone acetate 1% (PA) for 
      noninfectious anterior uveitis. MATERIALS AND METHODS: Forty-four patients were 
      randomized to 8% DSP-Visulex with placebo eye drops (8% group, n = 14), 15% 
      DSP-Visulex with placebo eye drops (15% group, n = 15), or Vehicle-Visulex with 
      PA eye drops (PA group, n = 15). Patients received daily eye drops and Visulex 
      treatments on days 1, 3, 8, and 15 with an optional treatment on day 22. Efficacy 
      measures were change in anterior chamber cell (ACC) count from baseline and 
      proportion of patients with zero ACC count at days 8, 15, and 29. Safety measures 
      were adverse events (AEs), visual acuity, ocular symptoms, and intraocular 
      pressure (IOP). RESULTS: ACC resolution over time was similar among the three 
      groups. The percentage of patients with clear ACC was 18%, 22%, and 15% on day 8; 
      27%, 56%, and 54% on day 15; and 90%, 88%, and 77% on day 29 for the 8%, 15%, and 
      PA groups, respectively. The numbers of reported AEs were 10, 36, and 12 for the 
      8%, 15%, and PA groups, respectively. Ten patients among all groups experienced 
      treatment-related AEs, which included headache, eye pain, corneal abrasion, 
      conjunctival/corneal staining, conjunctivitis, visual acuity reduction, and 
      keratitis all of which were resolved during the timeframe of patients' 
      participation in the study. IOP elevation was noted in the PA group throughout 
      the study, whereas IOP elevation in the DSP-Visulex groups was observed at day 3 
      but not thereafter. CONCLUSIONS: The efficacy of the DSP-Visulex applications was 
      comparable to the daily PA drops in the treatment of noninfectious anterior 
      uveitis. Both 8% and 15% DSP-Visulex treatments were safe and well tolerated.
FAU - Papangkorn, Kongnara
AU  - Papangkorn K
AD  - a Aciont Inc , Salt Lake City , UT , USA.
FAU - Truett, Kim R
AU  - Truett KR
AD  - b KCT Data Inc , Alpharetta , GA , USA.
FAU - Vitale, Albert T
AU  - Vitale AT
AD  - c John A Moran Eye Center , Salt Lake City , UT , USA.
FAU - Jhaveri, Chirag
AU  - Jhaveri C
AD  - d Retina Consultants of Austin , Austin , TX , USA.
FAU - Scales, David K
AU  - Scales DK
AD  - e Retina & Uveitis Consultants of Texas , San Antonio , TX , USA.
FAU - Foster, C Stephen
AU  - Foster CS
AD  - f Massachusetts Eye Research and Surgery Institution , Waltham , MA , USA.
FAU - Montieth, Alyssa
AU  - Montieth A
AD  - f Massachusetts Eye Research and Surgery Institution , Waltham , MA , USA.
FAU - Higuchi, John W
AU  - Higuchi JW
AD  - a Aciont Inc , Salt Lake City , UT , USA.
FAU - Brar, Balbir
AU  - Brar B
AD  - a Aciont Inc , Salt Lake City , UT , USA.
FAU - Higuchi, William I
AU  - Higuchi WI
AD  - a Aciont Inc , Salt Lake City , UT , USA.
LA  - eng
GR  - R44 EY014772/EY/NEI NIH HHS/United States
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20181115
PL  - England
TA  - Curr Eye Res
JT  - Current eye research
JID - 8104312
RN  - 0 (Glucocorticoids)
RN  - 0 (Ophthalmic Solutions)
RN  - 2BP70L44PR (dexamethasone 21-phosphate)
RN  - 7S5I7G3JQL (Dexamethasone)
SB  - IM
MH  - Administration, Topical
MH  - Adult
MH  - Aged
MH  - Anterior Chamber/*pathology
MH  - Cell Count
MH  - Dexamethasone/administration & dosage/*analogs & derivatives
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - Glucocorticoids/administration & dosage
MH  - Humans
MH  - Intraocular Pressure/physiology
MH  - Male
MH  - Middle Aged
MH  - Ophthalmic Solutions
MH  - Retrospective Studies
MH  - Slit Lamp Microscopy
MH  - Treatment Outcome
MH  - Uveitis, Anterior/diagnosis/*drug therapy/physiopathology
MH  - *Visual Acuity
MH  - Young Adult
OTO - NOTNLM
OT  - Ocular drug delivery
OT  - clinical trial
OT  - dexamethasone
OT  - safety and efficacy
OT  - uveitis
EDAT- 2018/10/26 06:00
MHDA- 2020/04/16 06:00
CRDT- 2018/10/26 06:00
PHST- 2018/10/26 06:00 [pubmed]
PHST- 2020/04/16 06:00 [medline]
PHST- 2018/10/26 06:00 [entrez]
AID - 10.1080/02713683.2018.1540707 [doi]
PST - ppublish
SO  - Curr Eye Res. 2019 Feb;44(2):185-193. doi: 10.1080/02713683.2018.1540707. Epub 
      2018 Nov 15.