PMID- 23484763
OWN - NLM
STAT- MEDLINE
DCOM- 20131025
LR  - 20220316
IS  - 1539-6304 (Electronic)
IS  - 1088-5412 (Linking)
VI  - 34
IP  - 3
DP  - 2013 May-Jun
TI  - Efficacy of bepotastine besilate ophthalmic solution 1.5% for seasonal allergic 
      conjunctivitis: a randomized, placebo-controlled, natural exposure, clinical 
      trial.
PG  - 247-54
AB  - Allergic conjunctivitis (AC) affects an estimated 20% of the population in the 
      Western world, with a large fraction suffering due to seasonal or perennial 
      allergen exposures. Bepotastine besilate ophthalmic solution (BBOS) 1.5%, a 
      dual-acting histamine (H(1)) receptor antagonist and mast cell stabilizer, is 
      indicated for itching associated with AC. This study was designed to evaluate the 
      efficacy and safety of BBOS 1.5% for reducing ocular itching associated with AC 
      in subjects enrolled in a natural exposure trial. Eligible subjects in a 
      multicenter, double-masked, randomized, parallel-group, placebo-controlled, 
      natural exposure clinical trial were randomly assigned to either BBOS 1.5% or 
      placebo eyedrops on a 1:1 basis and instilled 1 drop of the test agent into both 
      eyes twice daily for 2 weeks. The mean change from baseline in instantaneous and 
      reflective ocular itching scores at the end of 2 weeks of treatment were 
      evaluated based on subject-assessed severity of instantaneous and reflective 
      itching. Subject-reported adverse events (AEs) were also recorded for safety. 
      Treatment with BBOS 1.5% significantly reduced instantaneous and reflective 
      ocular itching scores from baseline compared with placebo over the 2-week study 
      period(p = 0.007 and p = 0.005, respectively). BBOS 1.5% was well tolerated, and 
      AEs were generally transient and mild. This clinical study indicates BBOS 1.5% 
      effectively and safely treated ocular itching in a natural exposure allergy study 
      and is a useful treatment option for the management of ocular itching associated 
      with AC. (ClinicalTrials.gov identifier number: NCT01174823.)
FAU - Carr, Warner W
AU  - Carr WW
AD  - Allergy and Asthma Association of Southern California, Mission Viejo, CA, USA.
FAU - Nayak, Anjuli S
AU  - Nayak AS
FAU - Ratner, Paul H
AU  - Ratner PH
FAU - Gow, James A
AU  - Gow JA
FAU - McNamara, Timothy R
AU  - McNamara TR
FAU - Williams, Jon I
AU  - Williams JI
CN  - Bepotastine Besilate Ophthalmic Solution 1.5% (Bepreve) Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT01174823
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Allergy Asthma Proc
JT  - Allergy and asthma proceedings
JID - 9603640
RN  - 0 (Anti-Allergic Agents)
RN  - 0 (Ophthalmic Solutions)
RN  - 0 (Piperidines)
RN  - 0 (Pyridines)
RN  - 6W18MO1QR3 (bepotastine besilate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Allergic Agents/*therapeutic use
MH  - Child
MH  - Conjunctivitis, Allergic/*drug therapy
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Intention to Treat Analysis
MH  - Male
MH  - Middle Aged
MH  - Ophthalmic Solutions
MH  - Piperidines/*therapeutic use
MH  - Pyridines/*therapeutic use
MH  - Seasons
MH  - Treatment Outcome
MH  - Young Adult
FIR - Berman, Gary
IR  - Berman G
FIR - Bernstein, David
IR  - Bernstein D
FIR - Carr, Warner
IR  - Carr W
FIR - Gower, Rich
IR  - Gower R
FIR - Hampel, Frank Jr
IR  - Hampel F Jr
FIR - Henderson, Diana
IR  - Henderson D
FIR - Nayak, Anjuli
IR  - Nayak A
FIR - Posner, Larry
IR  - Posner L
FIR - Ratner, Paul
IR  - Ratner P
FIR - Saff, Ronald
IR  - Saff R
FIR - Stillerman, Allan
IR  - Stillerman A
FIR - Wald, Jeffrey
IR  - Wald J
EDAT- 2013/03/15 06:00
MHDA- 2013/10/26 06:00
CRDT- 2013/03/15 06:00
PHST- 2013/03/15 06:00 [entrez]
PHST- 2013/03/15 06:00 [pubmed]
PHST- 2013/10/26 06:00 [medline]
AID - 3671 [pii]
AID - 10.2500/aap.2013.34.3671 [doi]
PST - ppublish
SO  - Allergy Asthma Proc. 2013 May-Jun;34(3):247-54. doi: 10.2500/aap.2013.34.3671.