PMID- 24136301
OWN - NLM
STAT- MEDLINE
DCOM- 20140831
LR  - 20220409
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Linking)
VI  - 30
IP  - 10
DP  - 2013 Oct
TI  - Loteprednol etabonate ophthalmic gel 0.5% following cataract surgery: integrated 
      analysis of two clinical studies.
PG  - 907-23
LID - 10.1007/s12325-013-0059-7 [doi]
AB  - INTRODUCTION: We aimed to evaluate the safety and efficacy of loteprednol 
      etabonate (LE) gel 0.5% compared with vehicle in the treatment of postoperative 
      inflammation and pain following cataract surgery, using the integrated analysis 
      of data from two identical, prospective, multicenter, randomized, double-masked, 
      parallel-group, vehicle-controlled trials. METHODS: Patients with anterior 
      chamber cell (ACC) inflammation >/= grade 2 (6-15 cells) 1 day post-surgery were 
      randomized to receive 1 or 2 drops of LE gel 0.5% or vehicle 4 times per day 
      instilled in the study eye for 14 days. Primary outcome measures included the 
      proportion of patients with complete resolution of ACC and grade 0 (no) pain on 
      postoperative Day 8. Safety endpoints included adverse events (AEs), changes from 
      baseline in intraocular pressure (IOP) and visual acuity (VA), biomicroscopy, and 
      funduscopy findings. Gel comfort was graded by patients according to drop 
      sensation. RESULTS: The intent-to-treat population included 813 patients (409 LE 
      gel 0.5% and 404 vehicle). At postoperative Day 8, 30.8% and 15.1% of patients 
      randomized to LE gel 0.5% or vehicle, respectively, had complete resolution of 
      ACC, while 74.3% and 43.8% of patients, respectively, had grade 0 pain (P < 0.001 
      for both). Tolerability assessments for ocular itching, photophobia, and tearing 
      favored LE gel 0.5% compared with vehicle at different time points beginning at 
      Day 3. Two patients in the LE gel 0.5% group and 1 patient in the vehicle group 
      exhibited a transient treatment-emergent increase in IOP >/= 10 mmHg. 
      Treatment-related AEs were generally mild to moderate and occurred less 
      frequently with LE gel 0.5% than with vehicle. Reports of treatment-related 
      blurred vision were rare (n = 2, vehicle). CONCLUSION: LE gel 0.5% was 
      efficacious and well tolerated in the treatment of postoperative pain and 
      inflammation following ocular surgery, with minimal risk of IOP elevation.
FAU - Rajpal, Rajesh K
AU  - Rajpal RK
AD  - See Clearly Vision Group, 8138 Watson Street, McLean, VA, 22102, USA, 
      RRajpal@seeclearly.com.
FAU - Fong, Raymond
AU  - Fong R
FAU - Comstock, Timothy L
AU  - Comstock TL
LA  - eng
SI  - ClinicalTrials.gov/NCT01010633
SI  - ClinicalTrials.gov/NCT01060072
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20131018
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Androstadienes)
RN  - 0 (Anti-Inflammatory Agents)
RN  - 0 (Gels)
RN  - YEH1EZ96K6 (Loteprednol Etabonate)
MH  - Administration, Ophthalmic
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Androstadienes/*therapeutic use
MH  - Anterior Chamber
MH  - Anti-Inflammatory Agents/*therapeutic use
MH  - *Cataract Extraction
MH  - Double-Blind Method
MH  - Female
MH  - Gels
MH  - Humans
MH  - Inflammation/*drug therapy
MH  - Loteprednol Etabonate
MH  - Male
MH  - Middle Aged
MH  - Pain, Postoperative/drug therapy
MH  - Postoperative Complications/*drug therapy
MH  - Treatment Outcome
EDAT- 2013/10/19 06:00
MHDA- 2014/09/01 06:00
CRDT- 2013/10/19 06:00
PHST- 2013/08/08 00:00 [received]
PHST- 2013/10/19 06:00 [entrez]
PHST- 2013/10/19 06:00 [pubmed]
PHST- 2014/09/01 06:00 [medline]
AID - 10.1007/s12325-013-0059-7 [doi]
PST - ppublish
SO  - Adv Ther. 2013 Oct;30(10):907-23. doi: 10.1007/s12325-013-0059-7. Epub 2013 Oct 
      18.