PMID- 21932014
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20121002
LR  - 20211020
IS  - 1869-5760 (Electronic)
IS  - 1869-5760 (Linking)
VI  - 1
IP  - 4
DP  - 2011 Dec
TI  - Phase II placebo-controlled study of nepafenac ophthalmic suspension 0.1% for 
      postoperative inflammation and ocular pain associated with cataract surgery in 
      Japanese patients.
PG  - 147-55
LID - 10.1007/s12348-011-0036-8 [doi]
AB  - OBJECTIVE: This study aimed to examine the efficacy and safety of nepafenac 
      ophthalmic suspension compared to placebo in the management of postoperative 
      inflammation and ocular pain in Japanese patients undergoing cataract surgery. 
      METHODS: This was a multicenter, randomized, double-masked, placebo-controlled 
      clinical study. Patients received nepafenac or placebo TID beginning 1 day before 
      cataract surgery and continuing on the day of surgery for 14 days. One additional 
      drop was administered on the day of surgery. The primary efficacy variables were 
      the percentage of patients cured at postoperative day 14 visit (cure defined as 
      aqueous cells score + aqueous flare score = 0) and the percentage of patients who 
      were pain free at all postoperative visits. RESULTS: The cure rate on day 14 
      after surgery was 71.4% (75/105) in the nepafenac group and 28.6% (30/105) in the 
      placebo group, showing a significant difference in cure rate between groups. The 
      nepafenac group demonstrated higher cure rates than those in the placebo group, 
      with a significant difference in cure rate on days 7 and 14 postoperatively. The 
      ocular pain-free rate was 96.2% (102/106) in the nepafenac group and 67.6% 
      (71/105) in the placebo group, showing a significant difference between groups. 
      Concerning adverse events (AEs), 26 AEs were reported in 21 subjects (19.6%) in 
      the nepafenac group and 31 AEs were reported in 24 subjects (22.4%) in the 
      placebo group. CONCLUSION: Nepafenac ophthalmic suspension is a nonsteroidal 
      anti-inflammatory drug effective in the prevention of postoperative inflammation 
      and ocular pain associated with cataract surgery.
FAU - Numaga, Jiro
AU  - Numaga J
AD  - Department of Ophthalmology, Tokyo Metropolitan Geriatric Hospital, 35-2 
      Sakae-cho, Itabashi-ku, Tokyo, 173-0015, Japan, jnumaga@mub.biglobe.ne.jp.
LA  - eng
PT  - Journal Article
DEP - 20110920
PL  - Germany
TA  - J Ophthalmic Inflamm Infect
JT  - Journal of ophthalmic inflammation and infection
JID - 101553216
PMC - PMC3223346
EDAT- 2011/09/21 06:00
MHDA- 2011/09/21 06:01
PMCR- 2011/09/20
CRDT- 2011/09/21 06:00
PHST- 2011/01/26 00:00 [received]
PHST- 2011/07/21 00:00 [accepted]
PHST- 2011/09/21 06:00 [entrez]
PHST- 2011/09/21 06:00 [pubmed]
PHST- 2011/09/21 06:01 [medline]
PHST- 2011/09/20 00:00 [pmc-release]
AID - 36 [pii]
AID - 10.1007/s12348-011-0036-8 [doi]
PST - ppublish
SO  - J Ophthalmic Inflamm Infect. 2011 Dec;1(4):147-55. doi: 
      10.1007/s12348-011-0036-8. Epub 2011 Sep 20.